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Dose Ranging Study Of Bococizumab (PF-04950615; RN316) In Hypercholesterolemic Japanese Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02055976
Recruitment Status : Completed
First Posted : February 5, 2014
Results First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hypercholesterolemia
Interventions Drug: Bococizumab (PF-04950615;RN316)
Drug: Placebo
Drug: Ezetimibe
Enrollment 218
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Period Title: Overall Study
Started 25 24 24 26 22 25 25 24 23
Completed 25 24 23 25 22 24 23 24 23
Not Completed 0 0 1 1 0 1 2 0 0
Reason Not Completed
Other             0             0             1             0             0             0             0             0             0
Adverse Event             0             0             0             0             0             1             1             0             0
Does not meet entrance criteria             0             0             0             0             0             0             1             0             0
Lost to Follow-up             0             0             0             1             0             0             0             0             0
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo Total
Hide Arm/Group Description Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. Total of all reporting groups
Overall Number of Baseline Participants 25 24 24 26 22 25 25 24 23 218
Hide Baseline Analysis Population Description
Safety analysis set included all randomized and non-randomized participants who were administered at least 1 dose of study treatment.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants 218 participants
Less than (<) 18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
18-44 years
1
   4.0%
3
  12.5%
1
   4.2%
3
  11.5%
2
   9.1%
1
   4.0%
3
  12.0%
3
  12.5%
2
   8.7%
19
   8.7%
45-64 years
18
  72.0%
10
  41.7%
16
  66.7%
14
  53.8%
14
  63.6%
16
  64.0%
14
  56.0%
20
  83.3%
12
  52.2%
134
  61.5%
Greater than or equal to (>=) 65 years
6
  24.0%
11
  45.8%
7
  29.2%
9
  34.6%
6
  27.3%
8
  32.0%
8
  32.0%
1
   4.2%
9
  39.1%
65
  29.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants 218 participants
Female
8
  32.0%
10
  41.7%
12
  50.0%
13
  50.0%
10
  45.5%
13
  52.0%
15
  60.0%
9
  37.5%
10
  43.5%
100
  45.9%
Male
17
  68.0%
14
  58.3%
12
  50.0%
13
  50.0%
12
  54.5%
12
  48.0%
10
  40.0%
15
  62.5%
13
  56.5%
118
  54.1%
1.Primary Outcome
Title Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 85
Hide Description LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Time Frame Baseline, Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all the participants who were randomized and administered at least 1 dose of study treatment.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 23 26 22 25 23 24 23
Mean (Standard Deviation)
Unit of Measure: percent change
-55.65  (15.748) -68.25  (18.769) -74.00  (13.848) -5.91  (14.323) -18.56  (15.968) -47.25  (17.699) -62.24  (16.097) -65.89  (10.779) -1.21  (14.815)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Adjusted mean difference and 2-sided 95% confidence interval were derived from the mixed-effect model for repeated measures (MMRM) model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-value (adjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -49.838
Confidence Interval (2-Sided) 95%
-57.335 to -42.340
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.775
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-value (adjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -66.754
Confidence Interval (2-Sided) 95%
-74.523 to -58.986
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.912
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -71.534
Confidence Interval (2-Sided) 95%
-79.284 to -63.784
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.903
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -47.531
Confidence Interval (2-Sided) 95%
-55.511 to -39.551
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.016
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -62.624
Confidence Interval (2-Sided) 95%
-70.557 to -54.691
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.993
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -64.268
Confidence Interval (2-Sided) 95%
-72.128 to -56.409
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.955
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 113
Hide Description LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Time Frame Baseline, Day 113
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, number of participants analyzed (N) signifies number of participants evaluable for this outcome measure.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 24 24 23 25 22 25 23 23 23
Mean (Standard Deviation)
Unit of Measure: percent change
-54.41  (12.062) -64.46  (19.149) -69.98  (19.074) -12.10  (12.727) -20.55  (18.682) -44.94  (19.641) -61.79  (15.476) -66.98  (12.396) 0.39  (16.246)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Adjusted mean difference and 2-sided 95% confidence interval were derived from the mixed-effect model for repeated measures (MMRM) model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -42.293
Confidence Interval (2-Sided) 95%
-49.417 to -35.168
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.587
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -56.262
Confidence Interval (2-Sided) 95%
-63.603 to -48.921
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.696
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -61.384
Confidence Interval (2-Sided) 95%
-68.733 to -54.035
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.700
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -47.578
Confidence Interval (2-Sided) 95%
-56.067 to -39.088
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.273
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -63.346
Confidence Interval (2-Sided) 95%
-71.776 to -54.915
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.244
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -66.691
Confidence Interval (2-Sided) 95%
-75.088 to -58.295
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.226
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Low Density Lipoprotein-Cholesterol (LDL-C)
Hide Description LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time Frame Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
135.36  (23.652) 123.85  (20.585) 129.19  (17.769) 135.90  (24.697) 135.36  (24.745) 164.22  (25.839) 158.00  (20.004) 159.90  (19.800) 155.22  (23.096)
Day 5 Number Analyzed 25 participants 23 participants 23 participants 26 participants 22 participants 25 participants 25 participants 24 participants 22 participants
86.72  (24.917) 71.83  (26.020) 76.04  (17.111) 130.35  (22.280) 111.50  (23.118) 128.68  (30.905) 120.20  (21.352) 114.63  (30.177) 165.09  (22.880)
Day 8 Number Analyzed 25 participants 24 participants 24 participants 25 participants 21 participants 25 participants 24 participants 22 participants 23 participants
70.36  (18.932) 55.38  (28.309) 57.71  (16.433) 132.08  (21.244) 105.86  (21.070) 118.20  (33.823) 102.63  (26.577) 96.50  (36.130) 167.22  (23.537)
Day 15 Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
73.76  (18.807) 51.96  (23.921) 39.00  (16.395) 132.50  (19.449) 102.64  (19.458) 113.28  (36.371) 80.44  (25.366) 77.08  (25.943) 165.39  (21.148)
Day 22 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
49.08  (19.577) 37.58  (20.011) 31.00  (11.176) 133.27  (19.359) 101.68  (21.825) 90.32  (34.956) 67.29  (26.527) 67.71  (32.399) 166.04  (15.741)
Day 29 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 25 participants 25 participants 24 participants 22 participants
61.56  (24.316) 48.29  (21.814) 34.26  (13.965) 129.60  (23.381) 107.50  (23.299) 93.36  (36.718) 65.20  (17.970) 63.58  (23.404) 168.14  (24.032)
Day 36 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
44.40  (19.967) 35.13  (17.306) 29.52  (11.233) 128.50  (23.930) 103.05  (26.462) 80.64  (34.744) 60.67  (19.257) 60.75  (27.619) 154.00  (22.815)
Day 43 Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
58.24  (21.357) 39.63  (20.342) 31.83  (11.750) 126.23  (14.356) 104.95  (23.941) 87.76  (36.555) 64.84  (19.882) 61.83  (29.732) 167.30  (21.850)
Day 50 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
39.76  (16.042) 32.33  (16.578) 29.96  (11.400) 127.92  (20.392) 106.23  (21.728) 76.96  (32.194) 57.91  (20.889) 59.29  (28.406) 158.83  (17.031)
Day 57 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
56.88  (18.306) 37.21  (18.352) 29.61  (11.053) 125.27  (20.330) 99.27  (26.705) 81.32  (33.628) 63.54  (25.072) 55.75  (26.272) 152.91  (15.395)
Day 71 Number Analyzed 24 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
61.50  (22.683) 36.29  (18.196) 33.13  (13.384) 130.31  (21.031) 109.18  (26.412) 90.96  (34.188) 60.63  (24.315) 57.33  (25.237) 156.70  (25.663)
Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
58.96  (19.650) 38.00  (19.077) 33.91  (19.400) 126.38  (21.478) 110.64  (33.530) 86.64  (30.447) 59.83  (27.495) 54.71  (18.388) 151.30  (21.137)
Day 99 Number Analyzed 25 participants 24 participants 22 participants 25 participants 22 participants 25 participants 24 participants 24 participants 23 participants
66.48  (23.208) 41.96  (18.995) 38.09  (25.183) 125.80  (15.992) 106.14  (31.001) 93.80  (29.672) 61.67  (31.175) 54.25  (20.339) 163.70  (17.778)
Day 106 Number Analyzed 25 participants 24 participants 22 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
45.16  (20.874) 32.13  (18.059) 37.36  (24.849) 127.76  (17.973) 104.14  (25.496) 84.52  (29.679) 57.00  (25.719) 57.42  (22.654) 155.57  (17.010)
Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
62.17  (20.417) 42.88  (19.427) 38.48  (24.346) 118.88  (22.883) 107.32  (30.459) 89.44  (29.798) 61.48  (28.511) 53.39  (20.954) 153.30  (16.255)
Day 127 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
108.16  (21.893) 86.71  (27.414) 61.87  (33.267) 131.92  (21.922) 132.73  (29.660) 137.00  (36.894) 87.22  (42.031) 78.96  (25.696) 161.17  (24.383)
Day 141 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
126.13  (26.555) 111.38  (24.588) 95.30  (37.497) 129.32  (20.860) 139.14  (38.095) 160.80  (37.487) 130.22  (40.707) 103.08  (34.759) 163.52  (22.224)
Day 155 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 23 participants 23 participants 24 participants 23 participants
126.52  (23.631) 113.75  (19.236) 110.57  (26.678) 133.92  (23.240) 139.45  (35.880) 165.17  (31.251) 140.78  (29.645) 119.54  (32.896) 158.17  (15.135)
Day 169 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 24 participants 23 participants 23 participants 22 participants
131.28  (25.988) 123.42  (25.782) 124.04  (24.453) 129.28  (24.576) 140.91  (39.309) 168.50  (28.657) 154.52  (21.715) 137.13  (32.817) 168.55  (19.767)
4.Secondary Outcome
Title Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Day 85 and Day 113
Hide Description LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time Frame Baseline, Day 85, 113
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: mg/dL
Change at Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
-76.40  (26.447) -85.85  (28.977) -95.11  (21.145) -9.52  (21.041) -24.73  (23.125) -77.58  (29.943) -99.28  (32.550) -105.19  (19.833) -3.91  (23.632)
Change at Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
-73.33  (18.047) -80.98  (28.902) -90.54  (28.496) -17.48  (20.767) -28.05  (23.663) -74.78  (34.970) -97.63  (25.545) -107.57  (21.765) -1.91  (20.147)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -67.254
Confidence Interval (2-Sided) 95%
-76.757 to -57.752
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.785
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -87.122
Confidence Interval (2-Sided) 95%
-96.969 to -77.275
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.959
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -93.327
Confidence Interval (2-Sided) 95%
-103.153 to -83.501
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.949
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -71.724
Confidence Interval (2-Sided) 95%
-84.128 to -59.321
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.243
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -96.206
Confidence Interval (2-Sided) 95%
-108.541 to -83.872
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.209
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -98.533
Confidence Interval (2-Sided) 95%
-110.743 to -86.323
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.145
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -56.225
Confidence Interval (2-Sided) 95%
-65.630 to -46.819
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.736
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -73.813
Confidence Interval (2-Sided) 95%
-83.507 to -64.119
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.881
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -81.239
Confidence Interval (2-Sided) 95%
-90.939 to -71.538
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.885
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -72.573
Confidence Interval (2-Sided) 95%
-84.461 to -60.684
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.983
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -96.222
Confidence Interval (2-Sided) 95%
-108.039 to -84.405
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.948
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -102.184
Confidence Interval (2-Sided) 95%
-113.945 to -90.424
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.919
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Total Cholesterol (TC)
Hide Description Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time Frame Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
214.16  (30.658) 210.29  (21.594) 211.71  (23.065) 222.44  (31.317) 222.84  (25.395) 245.94  (30.425) 243.26  (21.967) 244.19  (29.987) 242.04  (22.956)
Day 5 Number Analyzed 25 participants 23 participants 23 participants 26 participants 22 participants 25 participants 25 participants 24 participants 22 participants
169.20  (28.586) 154.83  (30.045) 156.91  (22.240) 219.42  (24.861) 197.77  (25.487) 211.56  (37.176) 203.56  (28.777) 199.58  (41.618) 249.09  (24.156)
Day 8 Number Analyzed 25 participants 24 participants 24 participants 25 participants 21 participants 25 participants 24 participants 22 participants 23 participants
149.72  (24.979) 137.71  (31.992) 136.50  (21.364) 222.68  (28.253) 190.19  (20.856) 202.44  (37.095) 184.58  (30.935) 186.73  (44.905) 254.26  (22.481)
Day 15 Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
154.20  (26.011) 137.83  (27.241) 120.75  (25.589) 221.69  (23.988) 190.50  (20.964) 198.64  (39.145) 165.48  (30.456) 165.71  (37.735) 251.91  (24.830)
Day 22 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
129.28  (22.856) 119.00  (26.462) 112.78  (19.247) 218.12  (24.006) 190.64  (23.768) 176.28  (36.510) 152.63  (29.854) 153.67  (43.213) 253.57  (15.716)
Day 29 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 25 participants 25 participants 24 participants 22 participants
141.04  (27.355) 133.54  (25.507) 114.91  (24.487) 217.12  (24.280) 192.41  (31.173) 176.36  (41.260) 153.20  (25.762) 150.42  (34.557) 256.73  (22.391)
Day 36 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
124.12  (22.380) 113.88  (25.000) 107.35  (19.590) 217.08  (26.204) 187.55  (30.803) 163.48  (39.528) 147.08  (25.568) 144.63  (40.577) 244.65  (24.356)
Day 43 Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
139.40  (23.944) 128.83  (30.724) 113.75  (23.167) 214.62  (19.179) 190.86  (28.734) 171.96  (40.287) 151.80  (23.638) 147.25  (41.429) 254.04  (19.793)
Day 50 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
120.04  (20.687) 112.63  (23.585) 107.74  (22.471) 215.42  (23.262) 189.18  (24.209) 161.00  (37.653) 145.22  (24.814) 144.17  (40.223) 246.09  (17.776)
Day 57 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
134.16  (25.826) 116.96  (24.489) 104.61  (20.045) 208.04  (23.282) 184.14  (31.148) 158.96  (39.046) 148.00  (30.107) 135.83  (39.794) 236.78  (16.105)
Day 71 Number Analyzed 24 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
142.13  (29.489) 121.04  (28.608) 113.48  (25.056) 218.38  (23.474) 192.91  (31.288) 174.64  (37.758) 146.17  (29.736) 142.42  (37.326) 243.74  (24.849)
Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
135.52  (25.161) 119.58  (24.959) 109.57  (27.611) 208.88  (24.747) 198.82  (36.000) 165.44  (32.651) 141.09  (31.318) 134.17  (30.972) 231.52  (22.701)
Day 99 Number Analyzed 25 participants 24 participants 22 participants 25 participants 22 participants 25 participants 24 participants 24 participants 23 participants
151.24  (31.139) 128.58  (28.864) 122.36  (36.702) 216.28  (19.250) 194.05  (33.230) 178.36  (33.103) 149.83  (33.780) 139.13  (32.510) 249.83  (19.277)
Day 106 Number Analyzed 25 participants 24 participants 22 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
126.40  (29.017) 114.75  (26.967) 118.55  (29.987) 212.36  (22.002) 190.27  (28.352) 167.84  (32.859) 142.26  (32.265) 139.92  (35.003) 241.65  (18.982)
Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
140.63  (26.650) 124.58  (27.910) 115.17  (30.293) 201.64  (26.967) 191.73  (34.189) 169.72  (31.052) 146.00  (33.889) 134.17  (31.400) 236.83  (16.808)
Day 127 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
193.96  (26.253) 176.88  (32.328) 147.87  (37.486) 219.32  (26.684) 221.18  (32.444) 223.16  (39.032) 176.74  (46.917) 166.63  (34.144) 249.78  (25.598)
Day 141 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
209.75  (32.446) 202.71  (26.989) 184.09  (38.141) 216.48  (22.450) 229.50  (38.480) 247.36  (40.025) 217.43  (43.351) 192.96  (37.406) 253.48  (21.494)
Day 155 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 23 participants 23 participants 24 participants 23 participants
208.32  (28.912) 203.83  (24.533) 195.26  (31.865) 221.28  (24.455) 228.86  (37.640) 250.00  (34.453) 227.83  (31.438) 208.25  (33.069) 246.35  (15.171)
Day 169 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 24 participants 23 participants 23 participants 22 participants
212.96  (29.508) 212.79  (25.267) 211.00  (31.348) 221.00  (26.091) 234.95  (43.216) 254.17  (32.859) 245.57  (34.103) 227.65  (39.088) 258.64  (20.537)
6.Secondary Outcome
Title Change From Baseline in Total Cholesterol (TC) at Day 85 and Day 113
Hide Description Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time Frame Baseline, Day 85, 113
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: mg/dL
Change at Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
-78.64  (28.525) -90.71  (31.705) -101.43  (25.436) -13.56  (22.346) -24.02  (26.166) -80.50  (31.851) -102.80  (34.603) -110.02  (24.119) -10.52  (26.111)
Change at Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
-73.44  (21.242) -85.71  (30.263) -95.83  (27.765) -21.68  (23.686) -31.11  (24.992) -76.22  (36.301) -97.89  (29.274) -111.96  (24.871) -5.22  (20.333)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-value (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -69.537
Confidence Interval (2-Sided) 95%
-80.900 to -58.175
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.721
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -86.446
Confidence Interval (2-Sided) 95%
-98.074 to -74.818
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.855
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -98.273
Confidence Interval (2-Sided) 95%
-109.983 to -86.563
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.898
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -71.435
Confidence Interval (2-Sided) 95%
-85.757 to -57.112
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.209
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -94.959
Confidence Interval (2-Sided) 95%
-109.333 to -80.585
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.236
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -98.519
Confidence Interval (2-Sided) 95%
-112.727 to -84.311
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.150
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -55.191
Confidence Interval (2-Sided) 95%
-66.592 to -43.791
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.741
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -72.211
Confidence Interval (2-Sided) 95%
-83.825 to -60.597
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.848
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -83.065
Confidence Interval (2-Sided) 95%
-94.807 to -71.323
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.913
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -73.879
Confidence Interval (2-Sided) 95%
-87.147 to -60.612
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.678
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -95.428
Confidence Interval (2-Sided) 95%
-108.732 to -82.124
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.697
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -104.859
Confidence Interval (2-Sided) 95%
-118.079 to -91.639
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.654
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percent Change From Baseline in Total Cholesterol (TC) at Day 85 and Day 113
Hide Description Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Time Frame Baseline, Day 85, 113
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: percent change
Change at Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
-36.26  (11.313) -42.64  (13.310) -48.22  (11.066) -5.47  (9.038) -10.85  (11.295) -32.56  (12.011) -41.98  (12.224) -45.28  (9.539) -3.82  (10.484)
Change at Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
-34.28  (8.799) -40.55  (13.471) -45.58  (12.422) -9.18  (9.204) -14.02  (10.900) -30.50  (13.212) -40.27  (11.798) -45.71  (9.786) -1.62  (8.941)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -31.642
Confidence Interval (2-Sided) 95%
-37.039 to -26.246
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.717
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -39.880
Confidence Interval (2-Sided) 95%
-45.403 to -34.358
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.781
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -45.889
Confidence Interval (2-Sided) 95%
-51.450 to -40.329
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.800
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -30.137
Confidence Interval (2-Sided) 95%
-36.110 to -24.164
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.006
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -39.525
Confidence Interval (2-Sided) 95%
-45.520 to -33.531
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.018
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -41.372
Confidence Interval (2-Sided) 95%
-47.299 to -35.445
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.983
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -25.374
Confidence Interval (2-Sided) 95%
-30.717 to -20.032
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.690
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -33.490
Confidence Interval (2-Sided) 95%
-38.934 to -28.047
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.741
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -38.760
Confidence Interval (2-Sided) 95%
-44.262 to -33.258
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.770
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -30.847
Confidence Interval (2-Sided) 95%
-36.568 to -25.127
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.879
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -40.019
Confidence Interval (2-Sided) 95%
-45.754 to -34.285
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.887
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -43.947
Confidence Interval (2-Sided) 95%
-49.647 to -38.247
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.869
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Apolipoprotein B (ApoB)
Hide Description ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time Frame Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
92.76  (14.383) 92.54  (12.362) 90.40  (12.732) 95.65  (13.229) 96.70  (13.382) 106.54  (15.800) 104.02  (14.652) 101.88  (11.494) 103.13  (13.608)
Day 5 Number Analyzed 25 participants 23 participants 23 participants 26 participants 22 participants 25 participants 25 participants 24 participants 22 participants
67.72  (15.175) 59.83  (14.269) 60.26  (8.853) 94.62  (12.847) 84.68  (13.570) 88.40  (18.777) 82.88  (13.179) 78.00  (14.025) 104.86  (11.902)
Day 8 Number Analyzed 25 participants 24 participants 24 participants 25 participants 21 participants 25 participants 24 participants 22 participants 23 participants
56.12  (12.245) 49.04  (15.982) 47.42  (9.050) 95.72  (16.395) 80.38  (13.113) 82.52  (19.402) 71.71  (13.614) 70.27  (16.237) 107.61  (11.357)
Day 15 Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
60.20  (15.658) 49.38  (15.528) 36.50  (8.703) 96.65  (13.069) 79.36  (9.639) 82.24  (21.127) 62.28  (16.403) 58.08  (12.265) 107.39  (12.052)
Day 22 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
44.28  (13.227) 36.83  (12.923) 31.09  (5.938) 96.35  (10.954) 79.77  (12.976) 68.76  (20.949) 53.46  (14.700) 50.54  (15.300) 108.35  (10.530)
Day 29 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 25 participants 25 participants 24 participants 22 participants
52.08  (16.595) 46.42  (16.264) 32.83  (8.611) 96.00  (11.800) 80.73  (12.691) 69.32  (20.613) 54.20  (12.285) 50.25  (11.752) 107.23  (12.134)
Day 36 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
41.04  (11.998) 35.50  (13.603) 29.43  (6.036) 96.27  (14.717) 80.18  (13.828) 62.40  (19.885) 49.25  (8.115) 46.92  (14.191) 103.74  (13.363)
Day 43 Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
51.36  (14.494) 42.50  (17.942) 31.96  (7.538) 94.31  (9.216) 82.68  (12.797) 67.24  (19.959) 53.60  (14.283) 48.50  (14.301) 110.39  (11.645)
Day 50 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
38.48  (10.759) 34.08  (12.728) 30.52  (6.660) 95.69  (12.802) 82.86  (12.822) 62.28  (19.932) 49.43  (11.469) 47.58  (14.443) 107.22  (11.062)
Day 57 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
49.44  (14.077) 38.29  (16.236) 29.48  (6.052) 93.81  (12.316) 79.68  (15.490) 62.00  (19.660) 53.25  (17.745) 45.79  (12.322) 104.13  (9.057)
Day 71 Number Analyzed 24 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
52.83  (16.903) 38.71  (16.648) 32.00  (7.634) 97.23  (11.884) 85.18  (14.378) 69.96  (19.673) 50.63  (11.568) 47.79  (12.112) 107.78  (16.082)
Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
51.32  (15.258) 39.21  (15.291) 33.65  (14.717) 93.46  (12.666) 86.77  (16.934) 68.68  (17.409) 49.35  (15.183) 45.13  (10.678) 102.09  (12.387)
Day 99 Number Analyzed 25 participants 24 participants 22 participants 25 participants 22 participants 25 participants 24 participants 24 participants 23 participants
57.36  (17.291) 44.29  (17.853) 37.55  (18.913) 95.08  (12.165) 84.05  (16.247) 72.56  (18.063) 53.63  (17.272) 45.88  (11.211) 110.91  (11.049)
Day 106 Number Analyzed 25 participants 24 participants 22 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
42.12  (13.233) 34.71  (15.029) 35.55  (15.987) 94.36  (12.192) 83.32  (14.965) 66.72  (17.111) 48.87  (13.168) 47.00  (12.332) 107.48  (10.117)
Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
53.50  (13.593) 42.83  (16.612) 36.48  (15.111) 88.40  (13.438) 82.77  (15.593) 69.08  (17.007) 52.52  (15.774) 45.87  (11.530) 105.61  (9.940)
Day 127 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
82.00  (13.871) 73.04  (21.566) 54.61  (24.203) 95.16  (12.216) 98.50  (16.280) 97.20  (20.827) 69.91  (28.257) 62.75  (19.525) 111.35  (14.288)
Day 141 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
89.50  (14.611) 87.71  (18.112) 74.87  (25.118) 95.08  (12.024) 100.45  (19.043) 108.96  (21.279) 92.70  (27.420) 77.67  (25.466) 110.09  (12.109)
Day 155 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 23 participants 23 participants 24 participants 23 participants
90.16  (14.291) 89.00  (15.836) 81.87  (16.652) 96.00  (11.832) 101.23  (18.619) 111.39  (17.758) 98.26  (19.262) 86.04  (23.451) 108.43  (10.422)
Day 169 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 24 participants 23 participants 23 participants 22 participants
93.36  (16.176) 93.63  (14.455) 91.57  (15.147) 96.88  (13.532) 103.09  (20.718) 112.46  (16.005) 105.91  (17.661) 95.74  (21.764) 111.41  (9.879)
9.Secondary Outcome
Title Change From Baseline in Apolipoprotein B (ApoB) at Day 85 and Day 113
Hide Description ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time Frame Baseline, Day 85, 113
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: mg/dL
Change at Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
-41.44  (16.385) -53.33  (19.097) -56.43  (17.650) -2.19  (10.703) -9.93  (14.350) -37.86  (18.125) -54.33  (21.080) -56.75  (14.506) -1.04  (13.020)
Change at Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
-39.56  (12.011) -49.71  (18.699) -53.61  (16.526) -7.70  (12.436) -13.93  (12.650) -37.46  (18.504) -51.15  (16.855) -56.83  (15.501) 2.48  (11.107)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -41.118
Confidence Interval (2-Sided) 95%
-47.760 to -34.476
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.344
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -54.787
Confidence Interval (2-Sided) 95%
-61.543 to -48.032
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.402
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -60.549
Confidence Interval (2-Sided) 95%
-67.403 to -53.694
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.453
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -36.589
Confidence Interval (2-Sided) 95%
-43.999 to -29.178
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.730
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -54.683
Confidence Interval (2-Sided) 95%
-62.102 to -47.265
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.734
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -56.517
Confidence Interval (2-Sided) 95%
-63.845 to -49.189
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.688
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -33.262
Confidence Interval (2-Sided) 95%
-39.608 to -26.915
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.196
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -45.956
Confidence Interval (2-Sided) 95%
-52.388 to -39.523
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.239
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -51.500
Confidence Interval (2-Sided) 95%
-58.063 to -44.937
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.305
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -40.474
Confidence Interval (2-Sided) 95%
-47.523 to -33.426
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.547
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -54.634
Confidence Interval (2-Sided) 95%
-61.685 to -47.583
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.549
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -59.608
Confidence Interval (2-Sided) 95%
-66.602 to -52.614
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.520
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein B (ApoB) at Day 85 and Day 113
Hide Description ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Time Frame Baseline, Day 85, 113
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: percent change
Change at Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
-44.30  (15.675) -57.02  (17.985) -62.31  (15.684) -1.77  (10.567) -9.97  (14.426) -35.16  (15.906) -51.62  (16.289) -55.31  (11.060) -0.13  (12.144)
Change at Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
-42.64  (11.864) -53.45  (18.449) -59.48  (15.320) -7.54  (11.662) -14.17  (12.713) -34.66  (16.214) -49.10  (14.474) -54.88  (12.109) 3.43  (12.038)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -43.265
Confidence Interval (2-Sided) 95%
-50.347 to -36.183
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.566
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -57.962
Confidence Interval (2-Sided) 95%
-65.167 to -50.758
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.628
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -64.729
Confidence Interval (2-Sided) 95%
-72.039 to -57.419
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.682
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -36.428
Confidence Interval (2-Sided) 95%
-43.451 to -29.405
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.535
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -53.296
Confidence Interval (2-Sided) 95%
-60.325 to -46.267
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.538
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -55.489
Confidence Interval (2-Sided) 95%
-62.436 to -48.542
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.496
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -35.288
Confidence Interval (2-Sided) 95%
-42.059 to -28.516
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.410
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -48.845
Confidence Interval (2-Sided) 95%
-55.709 to -41.982
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.456
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -55.114
Confidence Interval (2-Sided) 95%
-62.116 to -48.112
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.526
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -40.045
Confidence Interval (2-Sided) 95%
-47.118 to -32.971
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.560
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -53.810
Confidence Interval (2-Sided) 95%
-60.883 to -46.737
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.560
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -58.620
Confidence Interval (2-Sided) 95%
-65.640 to -51.600
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.533
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Apolipoprotein A-I (ApoA-I)
Hide Description ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time Frame Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
137.02  (13.235) 142.60  (16.507) 140.31  (18.813) 145.65  (21.908) 145.34  (16.171) 138.90  (21.808) 145.38  (19.260) 146.75  (25.587) 150.13  (16.834)
Day 5 Number Analyzed 25 participants 23 participants 23 participants 26 participants 22 participants 25 participants 25 participants 24 participants 22 participants
140.72  (14.644) 146.65  (16.773) 144.48  (19.943) 146.08  (21.505) 144.68  (16.193) 142.12  (22.260) 145.12  (18.485) 149.79  (24.285) 150.09  (17.989)
Day 8 Number Analyzed 25 participants 24 participants 24 participants 25 participants 21 participants 25 participants 24 participants 22 participants 23 participants
140.44  (14.972) 147.46  (16.707) 146.88  (19.200) 147.00  (21.527) 145.57  (16.351) 146.76  (25.406) 145.79  (19.260) 152.45  (28.118) 150.48  (16.782)
Day 15 Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
141.56  (13.811) 153.00  (16.325) 150.46  (20.479) 147.04  (22.704) 148.50  (18.918) 145.76  (23.197) 150.08  (20.762) 157.04  (25.154) 151.00  (19.214)
Day 22 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
143.20  (15.554) 152.88  (18.473) 151.78  (20.576) 145.31  (21.481) 146.41  (17.012) 145.96  (22.354) 150.08  (19.019) 155.17  (23.265) 151.65  (17.185)
Day 29 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 25 participants 25 participants 24 participants 22 participants
144.32  (15.118) 155.79  (19.598) 151.78  (22.913) 144.28  (20.633) 146.23  (17.221) 146.36  (22.503) 150.04  (21.763) 155.96  (23.143) 154.32  (15.304)
Day 36 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
143.48  (15.273) 149.88  (17.957) 150.13  (21.102) 143.46  (20.609) 145.91  (18.652) 145.08  (22.953) 153.33  (19.417) 155.08  (24.063) 149.30  (18.639)
Day 43 Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
144.52  (12.842) 153.88  (18.262) 150.33  (22.584) 142.42  (21.495) 144.64  (16.105) 146.00  (21.050) 152.32  (21.059) 155.75  (32.193) 149.04  (16.932)
Day 50 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
145.80  (15.042) 151.25  (19.157) 149.13  (19.008) 143.46  (20.397) 141.95  (15.807) 142.84  (21.885) 152.52  (19.739) 153.92  (25.100) 145.70  (14.348)
Day 57 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
138.40  (14.919) 149.46  (19.509) 145.83  (18.930) 137.62  (18.206) 142.18  (15.445) 136.32  (20.010) 145.96  (22.029) 144.96  (25.049) 138.87  (16.491)
Day 71 Number Analyzed 24 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
145.50  (16.192) 152.92  (21.086) 150.43  (21.002) 142.62  (19.150) 144.18  (15.383) 143.88  (21.896) 151.88  (17.523) 154.25  (23.130) 146.17  (14.981)
Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
138.04  (14.968) 148.17  (16.818) 144.04  (15.933) 136.00  (20.229) 144.23  (14.498) 132.88  (19.303) 145.13  (17.168) 146.58  (23.006) 136.30  (16.753)
Day 99 Number Analyzed 25 participants 24 participants 22 participants 25 participants 22 participants 25 participants 24 participants 24 participants 23 participants
147.40  (18.771) 154.54  (17.840) 150.86  (21.108) 147.48  (20.799) 145.91  (16.798) 143.88  (19.577) 151.29  (21.612) 149.83  (20.750) 144.65  (19.812)
Day 106 Number Analyzed 25 participants 24 participants 22 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
145.92  (18.773) 154.96  (19.282) 150.23  (18.341) 143.12  (17.822) 144.64  (15.413) 142.56  (21.143) 149.26  (19.909) 150.46  (21.444) 141.17  (15.497)
Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
139.21  (15.731) 149.17  (18.719) 144.13  (18.587) 137.72  (21.454) 145.00  (14.690) 138.40  (19.581) 149.09  (18.033) 143.96  (21.353) 140.04  (16.767)
Day 127 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
144.08  (18.630) 148.75  (17.738) 150.04  (23.145) 145.60  (22.763) 144.27  (14.701) 141.68  (20.412) 148.48  (18.012) 149.17  (23.566) 144.48  (15.237)
Day 141 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
145.46  (19.006) 151.21  (18.990) 154.17  (22.321) 148.52  (23.261) 144.45  (16.721) 141.36  (20.968) 148.74  (17.324) 151.29  (22.831) 149.13  (19.328)
Day 155 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 23 participants 23 participants 24 participants 23 participants
143.52  (17.564) 148.83  (20.267) 149.52  (21.848) 147.60  (23.076) 147.09  (16.446) 140.96  (23.437) 148.09  (21.037) 149.13  (23.899) 148.83  (18.077)
Day 169 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 24 participants 23 participants 23 participants 22 participants
142.96  (20.387) 151.54  (19.010) 150.96  (19.025) 154.88  (23.938) 153.64  (21.367) 144.13  (24.746) 151.70  (21.699) 151.13  (29.425) 154.36  (19.742)
12.Secondary Outcome
Title Change From Baseline in Apolipoprotein A-I (ApoA-I) at Day 85 and Day 113
Hide Description ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time Frame Baseline, Day 85, 113
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: mg/dL
Change at Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
1.02  (9.479) 5.56  (10.575) 3.63  (11.155) -9.65  (9.495) -1.11  (11.118) -6.02  (11.069) -2.09  (12.040) -0.17  (11.897) -13.83  (10.602)
Change at Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
2.52  (9.226) 6.56  (12.310) 3.72  (11.977) -7.86  (13.052) -0.34  (10.783) -0.50  (9.512) 1.87  (9.328) -3.54  (8.982) -10.09  (11.236)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 8.896
Confidence Interval (2-Sided) 95%
3.646 to 14.145
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.643
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 15.429
Confidence Interval (2-Sided) 95%
10.141 to 20.717
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.662
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 12.321
Confidence Interval (2-Sided) 95%
6.959 to 17.683
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.700
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 6.804
Confidence Interval (2-Sided) 95%
0.761 to 12.847
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.041
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 10.565
Confidence Interval (2-Sided) 95%
4.556 to 16.573
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.023
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 12.895
Confidence Interval (2-Sided) 95%
6.993 to 18.796
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.969
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 8.644
Confidence Interval (2-Sided) 95%
2.157 to 15.130
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.266
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 14.708
Confidence Interval (2-Sided) 95%
8.208 to 21.208
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.272
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 11.168
Confidence Interval (2-Sided) 95%
4.580 to 17.757
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.317
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 8.132
Confidence Interval (2-Sided) 95%
2.947 to 13.316
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.609
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 10.230
Confidence Interval (2-Sided) 95%
5.079 to 15.381
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.592
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 5.767
Confidence Interval (2-Sided) 95%
0.670 to 10.864
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.565
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Day 85 and Day 113
Hide Description ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Time Frame Baseline, Day 85, 113
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: percent change
Change at Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
0.87  (7.002) 4.20  (7.438) 3.26  (8.418) -6.44  (6.252) -0.34  (7.749) -3.82  (8.033) -1.00  (8.245) 0.44  (8.673) -9.10  (6.738)
Change at Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
1.93  (6.789) 4.82  (8.766) 3.13  (8.663) -5.16  (8.106) 0.15  (7.819) 0.13  (7.013) 1.53  (6.572) -1.84  (5.923) -6.55  (6.903)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 6.079
Confidence Interval (2-Sided) 95%
2.296 to 9.863
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.905
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 10.786
Confidence Interval (2-Sided) 95%
6.976 to 14.597
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.918
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 9.069
Confidence Interval (2-Sided) 95%
5.206 to 12.932
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.945
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 4.859
Confidence Interval (2-Sided) 95%
0.541 to 9.178
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.173
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 7.331
Confidence Interval (2-Sided) 95%
3.037 to 11.624
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.161
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 9.075
Confidence Interval (2-Sided) 95%
4.856 to 13.293
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.122
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 5.936
Confidence Interval (2-Sided) 95%
1.435 to 10.437
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.266
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 10.213
Confidence Interval (2-Sided) 95%
5.702 to 14.724
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.271
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 8.056
Confidence Interval (2-Sided) 95%
3.484 to 12.629
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.302
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 5.846
Confidence Interval (2-Sided) 95%
2.312 to 9.380
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.778
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 6.910
Confidence Interval (2-Sided) 95%
3.400 to 10.421
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.766
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 4.168
Confidence Interval (2-Sided) 95%
0.693 to 7.642
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.748
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Apolipoprotein A-II (ApoA-II)
Hide Description ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time Frame Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
30.700  (3.6817) 30.223  (2.8992) 30.471  (2.8918) 31.515  (3.8373) 32.189  (3.2855) 29.940  (3.3630) 31.232  (3.9681) 30.294  (3.0541) 31.354  (3.9552)
Day 5 Number Analyzed 25 participants 23 participants 23 participants 26 participants 22 participants 25 participants 25 participants 24 participants 22 participants
30.884  (3.6551) 30.161  (2.9004) 30.443  (3.4057) 31.608  (3.6099) 32.709  (3.4130) 30.088  (3.4784) 30.972  (4.2462) 30.558  (3.0567) 31.473  (4.1750)
Day 8 Number Analyzed 25 participants 24 participants 24 participants 25 participants 21 participants 25 participants 24 participants 22 participants 23 participants
30.224  (2.8736) 30.675  (3.1077) 30.738  (2.9137) 32.036  (3.2261) 32.495  (3.0372) 30.760  (3.3363) 30.608  (3.8492) 30.664  (3.2942) 31.635  (3.6272)
Day 15 Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
30.528  (3.7034) 31.129  (2.9304) 31.304  (3.0309) 32.062  (3.2968) 33.136  (3.6822) 30.568  (3.3308) 31.516  (3.9116) 31.275  (3.4925) 31.530  (4.6451)
Day 22 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
31.232  (3.1787) 30.667  (3.4561) 31.183  (3.8763) 31.846  (3.0899) 32.273  (3.2310) 30.620  (3.3448) 31.125  (4.0921) 30.896  (3.0900) 32.200  (3.6940)
Day 29 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 25 participants 25 participants 24 participants 22 participants
31.608  (3.2712) 32.279  (4.1331) 31.035  (3.7585) 32.096  (3.6363) 32.395  (3.1748) 30.740  (3.0899) 31.100  (3.6272) 31.071  (2.8639) 31.882  (3.6960)
Day 36 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
31.208  (3.5747) 30.838  (3.3920) 30.622  (3.3870) 31.150  (3.3011) 32.091  (4.0243) 29.768  (3.2825) 31.404  (4.0581) 30.975  (3.3526) 31.478  (3.7066)
Day 43 Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
31.600  (3.8155) 31.908  (4.2809) 31.004  (3.6090) 31.685  (3.6743) 32.636  (3.1568) 30.720  (3.6371) 32.408  (4.0300) 31.138  (3.4691) 31.922  (3.8381)
Day 50 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
31.772  (3.9676) 31.117  (3.5511) 30.991  (2.9264) 31.900  (3.5621) 32.282  (3.5327) 29.760  (3.8077) 32.704  (3.8668) 31.083  (3.8423) 30.830  (3.7644)
Day 57 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
30.708  (5.1285) 30.271  (4.0390) 29.987  (3.2086) 30.773  (3.4292) 32.405  (3.0798) 28.548  (3.8710) 31.454  (4.3687) 30.033  (3.9031) 29.861  (3.3007)
Day 71 Number Analyzed 24 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
32.600  (4.3091) 31.554  (4.3823) 31.148  (2.8016) 32.092  (3.5748) 33.127  (3.3208) 30.260  (3.9125) 32.658  (3.9677) 31.804  (3.5119) 31.317  (4.0283)
Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
30.484  (4.5441) 30.296  (4.2019) 29.974  (3.3766) 30.577  (4.1019) 33.095  (3.4642) 29.036  (3.6811) 31.957  (4.8917) 30.533  (4.0376) 29.657  (3.6082)
Day 99 Number Analyzed 25 participants 24 participants 22 participants 25 participants 22 participants 25 participants 24 participants 24 participants 23 participants
32.868  (4.2145) 32.054  (4.3729) 31.436  (3.7821) 32.500  (4.3987) 33.155  (3.9087) 31.352  (3.8161) 32.925  (5.9562) 31.229  (2.9670) 31.570  (4.3204)
Day 106 Number Analyzed 25 participants 24 participants 22 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
31.908  (4.1181) 31.850  (3.8284) 31.073  (3.3504) 31.724  (3.5444) 32.432  (3.6429) 30.520  (3.9332) 32.552  (4.3131) 31.438  (3.7623) 30.865  (3.7092)
Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
30.442  (4.1097) 30.313  (4.1545) 29.787  (3.3975) 30.388  (3.3572) 32.559  (3.0055) 29.300  (3.3821) 32.361  (4.1480) 30.239  (3.2747) 30.126  (3.5101)
Day 127 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
32.068  (3.9869) 31.358  (3.9263) 31.370  (3.4158) 31.824  (3.4922) 32.905  (3.2614) 30.904  (3.1115) 32.374  (3.7973) 31.242  (3.5215) 31.839  (3.7256)
Day 141 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
32.704  (4.5005) 32.325  (4.2787) 32.835  (3.3582) 32.044  (4.2146) 32.818  (3.4188) 31.412  (3.6261) 33.287  (3.0694) 32.029  (3.4970) 32.178  (3.1213)
Day 155 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 23 participants 23 participants 24 participants 23 participants
32.164  (3.9476) 31.629  (4.4463) 31.878  (3.3637) 31.956  (4.1374) 32.877  (3.7858) 31.061  (3.8024) 32.891  (4.0870) 31.867  (3.6487) 31.439  (3.4050)
Day 169 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 24 participants 23 participants 23 participants 22 participants
31.848  (4.1778) 32.033  (3.8588) 32.352  (3.8903) 33.120  (4.2339) 33.623  (4.2722) 31.433  (3.8678) 33.578  (4.4671) 32.070  (3.9987) 32.345  (3.6908)
15.Secondary Outcome
Title Change From Baseline in Apolipoprotein A-II (ApoA-II) at Day 85 and Day 113
Hide Description ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time Frame Baseline, Day 85, 113
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: mg/dL
Change at Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
-0.216  (2.2274) 0.073  (2.6605) -0.450  (2.3906) -0.938  (1.8339) 0.907  (2.6785) -0.904  (2.3894) 0.354  (3.3769) 0.240  (3.1812) -1.698  (2.9589)
Change at Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
-0.073  (2.0937) 0.090  (2.3882) -0.637  (2.2412) -1.104  (4.0438) 0.370  (2.2388) -0.640  (2.0394) 0.759  (2.2739) 0.002  (2.8256) -1.228  (3.4404)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.127
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.7208
Confidence Interval (2-Sided) 95%
-0.5283 to 1.9700
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.6289
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.053
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 1.0574
Confidence Interval (2-Sided) 95%
-0.2259 to 2.3406
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.6461
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.354
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.2445
Confidence Interval (2-Sided) 95%
-1.0486 to 1.5375
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.6511
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.176
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.8055
Confidence Interval (2-Sided) 95%
-0.9066 to 2.5177
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.8615
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 2.0071
Confidence Interval (2-Sided) 95%
0.2899 to 3.7242
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.8641
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 1.7116
Confidence Interval (2-Sided) 95%
0.0184 to 3.4049
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.8520
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.138
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.8585
Confidence Interval (2-Sided) 95%
-0.6992 to 2.4163
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.7844
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.137
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.8807
Confidence Interval (2-Sided) 95%
-0.7064 to 2.4678
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.7990
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.373
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.2624
Confidence Interval (2-Sided) 95%
-1.3370 to 1.8618
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.8053
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.333
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.3239
Confidence Interval (2-Sided) 95%
-1.1611 to 1.8089
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.7472
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 1.9322
Confidence Interval (2-Sided) 95%
0.4441 to 3.4203
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.7488
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.133
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.8340
Confidence Interval (2-Sided) 95%
-0.6451 to 2.3130
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.7442
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Day 85 and Day 113
Hide Description ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Time Frame Baseline, Day 85, 113
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: percent change
Change at Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
-0.85  (7.387) 0.17  (8.699) -1.34  (7.672) -2.93  (5.741) 3.13  (8.288) -2.87  (7.788) 1.34  (10.779) 0.98  (10.565) -4.97  (9.262)
Change at Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
-0.21  (6.972) 0.13  (7.974) -1.99  (7.403) -2.77  (11.234) 1.48  (6.776) -1.94  (6.337) 2.64  (7.315) 0.39  (9.526) -3.29  (10.137)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.155
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 2.0813
Confidence Interval (2-Sided) 95%
-1.9730 to 6.1356
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.0411
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.062
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 3.2608
Confidence Interval (2-Sided) 95%
-0.9035 to 7.4250
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.0965
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.349
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.8224
Confidence Interval (2-Sided) 95%
-3.3733 to 5.0182
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.1126
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.202
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 2.3254
Confidence Interval (2-Sided) 95%
-3.1801 to 7.8310
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.7702
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 6.1048
Confidence Interval (2-Sided) 95%
0.5833 to 11.6263
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.7784
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 5.2393
Confidence Interval (2-Sided) 95%
-0.2058 to 10.6845
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.7396
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.185
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 2.1827
Confidence Interval (2-Sided) 95%
-2.6334 to 6.9988
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.4251
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.195
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 2.1376
Confidence Interval (2-Sided) 95%
-2.7718 to 7.0469
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.4716
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.450
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.3113
Confidence Interval (2-Sided) 95%
-4.6358 to 5.2584
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.4909
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.397
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.6078
Confidence Interval (2-Sided) 95%
-4.0274 to 5.2431
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.3322
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 5.7096
Confidence Interval (2-Sided) 95%
1.0659 to 10.3532
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.3367
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.147
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 2.4558
Confidence Interval (2-Sided) 95%
-2.1608 to 7.0724
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.3230
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Lipoprotein (a) (Lp[a])
Hide Description Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time Frame Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
18.452  (13.1792) 20.998  (17.2111) 18.840  (16.7289) 19.265  (14.3646) 19.468  (18.4181) 14.080  (11.9369) 15.458  (12.6296) 13.400  (9.0719) 16.239  (10.1883)
Day 5 Number Analyzed 25 participants 23 participants 23 participants 26 participants 22 participants 25 participants 25 participants 24 participants 22 participants
16.224  (13.4935) 18.348  (17.7316) 16.204  (16.6072) 18.523  (15.2512) 20.450  (18.8904) 12.464  (10.5751) 14.580  (12.2541) 11.783  (9.3506) 15.859  (10.9932)
Day 8 Number Analyzed 25 participants 24 participants 24 participants 25 participants 21 participants 25 participants 24 participants 22 participants 23 participants
14.892  (13.2944) 15.333  (18.3499) 14.167  (15.5022) 19.184  (14.7461) 17.243  (15.7353) 12.000  (11.8358) 12.617  (10.4189) 12.768  (8.9168) 16.443  (12.1793)
Day 15 Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
14.208  (12.9280) 14.129  (17.8567) 11.392  (14.1251) 19.258  (16.0484) 18.982  (20.4348) 10.140  (10.0017) 12.548  (10.9860) 9.996  (8.1113) 16.443  (11.4594)
Day 22 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
12.628  (12.4393) 12.446  (16.1397) 10.765  (13.3504) 18.785  (16.0604) 17.800  (18.6499) 10.936  (10.1920) 11.583  (11.3914) 8.800  (7.1835) 16.026  (11.0080)
Day 29 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 25 participants 25 participants 24 participants 22 participants
12.832  (12.3874) 13.379  (16.2405) 10.552  (12.7986) 18.304  (15.6050) 17.873  (18.0678) 10.424  (10.6085) 10.888  (9.8450) 9.312  (7.3675) 17.423  (11.1746)
Day 36 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
11.152  (11.9088) 12.833  (16.0418) 10.409  (12.7145) 17.046  (14.4893) 18.050  (19.5448) 9.484  (10.6692) 10.329  (9.7943) 8.067  (6.7186) 15.843  (10.8050)
Day 43 Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
11.648  (12.2798) 12.525  (16.1360) 9.633  (12.4360) 16.912  (14.1356) 17.214  (18.6825) 9.380  (9.6416) 9.944  (9.7431) 8.821  (7.6426) 15.961  (10.3890)
Day 50 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
10.344  (11.3684) 11.675  (14.8818) 9.039  (12.0250) 16.835  (14.2068) 17.314  (19.6439) 10.040  (10.4835) 10.191  (9.2630) 7.621  (6.5659) 15.078  (9.7608)
Day 57 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
10.708  (10.3883) 10.871  (13.5224) 8.578  (11.2275) 15.892  (14.0990) 17.573  (21.9401) 9.392  (10.2457) 9.487  (8.2801) 6.858  (6.2894) 14.313  (9.3930)
Day 71 Number Analyzed 24 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
11.358  (12.3793) 11.354  (14.0492) 9.009  (11.7733) 16.542  (13.5029) 16.991  (20.0151) 9.248  (11.4972) 9.529  (8.6412) 6.979  (6.5414) 13.500  (9.4333)
Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
10.960  (11.6806) 10.879  (14.1289) 9.239  (11.1448) 16.519  (14.5691) 17.609  (19.7001) 8.808  (10.3417) 9.261  (7.6804) 6.637  (5.6695) 12.726  (8.9598)
Day 99 Number Analyzed 25 participants 24 participants 22 participants 25 participants 22 participants 25 participants 24 participants 24 participants 23 participants
12.232  (12.5326) 11.837  (15.6082) 8.855  (13.9399) 15.764  (14.4527) 16.868  (19.6709) 7.940  (9.6343) 8.537  (7.6094) 6.792  (5.6212) 13.691  (9.5937)
Day 106 Number Analyzed 25 participants 24 participants 22 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
10.756  (11.7377) 11.079  (14.2590) 9.123  (14.1064) 15.396  (12.8944) 16.682  (18.8434) 8.608  (9.5662) 8.296  (7.3410) 6.858  (6.1058) 12.800  (8.9601)
Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
12.108  (12.3479) 11.183  (14.5312) 9.565  (14.0691) 14.492  (12.9060) 16.814  (17.8976) 8.020  (9.0412) 8.287  (7.6439) 6.787  (5.8743) 12.913  (9.7212)
Day 127 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
15.476  (14.6308) 15.112  (16.5781) 11.961  (15.6073) 15.500  (13.0255) 16.618  (19.1791) 9.864  (10.2016) 10.543  (9.2205) 7.642  (6.9977) 13.596  (9.3340)
Day 141 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
16.842  (15.6809) 17.329  (18.9837) 14.422  (17.3620) 15.828  (13.7114) 17.236  (18.8525) 10.100  (10.9325) 11.996  (10.0494) 8.442  (6.7945) 13.139  (9.2951)
Day 155 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 23 participants 23 participants 24 participants 23 participants
17.264  (15.4506) 17.483  (19.9385) 16.052  (16.9174) 16.004  (13.7418) 17.382  (19.8297) 10.204  (11.2720) 13.465  (10.8114) 9.600  (7.5028) 13.183  (9.1710)
Day 169 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 24 participants 23 participants 23 participants 22 participants
17.824  (15.1879) 17.404  (18.0405) 16.635  (17.8211) 15.384  (13.7150) 17.059  (20.8409) 11.271  (11.4561) 13.613  (11.5074) 10.626  (8.0902) 14.741  (10.3647)
18.Secondary Outcome
Title Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 85 and Day 113
Hide Description Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time Frame Baseline, Day 85, 113
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: mg/dL
Change at Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
-7.492  (5.1400) -10.119  (5.4374) -10.239  (8.2471) -2.746  (3.1292) -1.859  (3.0759) -5.272  (5.1528) -7.100  (5.9402) -6.763  (5.3474) -3.513  (3.6550)
Change at Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
-6.815  (4.6182) -9.815  (5.0568) -9.913  (6.6763) -3.574  (4.0251) -2.655  (3.1725) -6.060  (4.5477) -8.074  (6.0886) -7.098  (4.5025) -3.326  (3.4975)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -4.9203
Confidence Interval (2-Sided) 95%
-7.5504 to -2.2901
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.3242
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -7.1983
Confidence Interval (2-Sided) 95%
-9.8718 to -4.5249
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.3462
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -7.3118
Confidence Interval (2-Sided) 95%
-9.9935 to -4.6301
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.3505
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -3.0629
Confidence Interval (2-Sided) 95%
-5.1132 to -1.0125
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.0320
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -3.6209
Confidence Interval (2-Sided) 95%
-5.6804 to -1.5614
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.0367
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -4.1778
Confidence Interval (2-Sided) 95%
-6.2184 to -2.1372
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.0269
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -3.2914
Confidence Interval (2-Sided) 95%
-5.8649 to -0.7178
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.2954
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -6.3569
Confidence Interval (2-Sided) 95%
-8.9706 to -3.7432
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.3157
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -6.3962
Confidence Interval (2-Sided) 95%
-9.0247 to -3.7677
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.3233
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -3.9228
Confidence Interval (2-Sided) 95%
-5.7506 to -2.0950
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.9199
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -4.7094
Confidence Interval (2-Sided) 95%
-6.5459 to -2.8729
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.9244
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -4.4374
Confidence Interval (2-Sided) 95%
-6.2630 to -2.6118
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.9187
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 85 and Day 113
Hide Description Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Time Frame Baseline, Day 85, 113
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: percent change
Change at Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
-47.11  (20.802) -58.53  (22.181) -46.51  (63.192) -19.37  (25.160) -15.22  (23.532) -37.85  (27.223) -37.29  (24.552) -43.37  (39.755) -18.40  (30.139)
Change at Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
-42.30  (19.223) -57.94  (22.317) -59.42  (21.689) -24.35  (21.348) -18.64  (18.300) -45.26  (22.490) -47.60  (19.448) -49.77  (25.417) -15.89  (36.642)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -27.4492
Confidence Interval (2-Sided) 95%
-47.7872 to -7.1112
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.2401
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -40.5908
Confidence Interval (2-Sided) 95%
-61.3577 to -19.8240
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.4568
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -27.1630
Confidence Interval (2-Sided) 95%
-48.0927 to -6.2332
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.5402
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -24.1677
Confidence Interval (2-Sided) 95%
-41.8023 to -6.5332
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.8755
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -19.2255
Confidence Interval (2-Sided) 95%
-36.9471 to -1.5038
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.9203
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -26.5155
Confidence Interval (2-Sided) 95%
-44.0795 to -8.9515
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.8387
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -18.3898
Confidence Interval (2-Sided) 95%
-28.6698 to -8.1097
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.1768
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -36.7882
Confidence Interval (2-Sided) 95%
-47.2423 to -26.3341
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.2640
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -36.8453
Confidence Interval (2-Sided) 95%
-47.3864 to -26.3041
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.3084
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -32.9411
Confidence Interval (2-Sided) 95%
-48.5748 to -17.3075
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.8656
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -31.3176
Confidence Interval (2-Sided) 95%
-47.0238 to -15.6114
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.9032
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -32.8470
Confidence Interval (2-Sided) 95%
-48.4650 to -17.2289
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.8576
Estimation Comments [Not Specified]
20.Secondary Outcome
Title High Density Lipoprotein- Cholesterol (HDL-C)
Hide Description HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time Frame Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
54.58  (9.048) 54.75  (11.789) 57.00  (12.858) 58.54  (14.683) 56.98  (9.607) 57.22  (14.146) 60.40  (13.228) 62.02  (21.455) 60.87  (10.606)
Day 5 Number Analyzed 25 participants 23 participants 23 participants 26 participants 22 participants 25 participants 25 participants 24 participants 22 participants
55.68  (11.131) 57.04  (12.532) 58.43  (13.480) 58.19  (14.403) 57.00  (9.866) 57.20  (15.785) 60.32  (13.643) 62.08  (21.354) 59.73  (11.344)
Day 8 Number Analyzed 25 participants 24 participants 24 participants 25 participants 21 participants 25 participants 24 participants 22 participants 23 participants
56.48  (11.266) 58.38  (12.700) 60.33  (13.017) 60.52  (14.234) 58.67  (10.136) 59.60  (15.729) 61.33  (14.230) 64.00  (23.420) 60.57  (11.289)
Day 15 Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
58.52  (8.637) 59.96  (11.925) 62.79  (15.562) 59.35  (15.179) 60.23  (12.208) 60.24  (16.048) 62.32  (15.513) 66.58  (22.085) 60.30  (11.117)
Day 22 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
59.36  (11.158) 60.08  (12.176) 64.52  (14.585) 58.08  (12.743) 60.05  (10.017) 60.92  (16.253) 63.92  (13.529) 65.38  (17.358) 61.48  (11.233)
Day 29 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 25 participants 25 participants 24 participants 22 participants
59.96  (10.486) 61.75  (13.553) 63.83  (15.948) 57.96  (13.192) 59.00  (9.587) 60.84  (16.222) 62.52  (15.196) 67.96  (20.412) 64.14  (9.896)
Day 36 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
57.92  (10.622) 60.50  (13.112) 62.39  (14.151) 57.62  (13.518) 58.23  (10.314) 59.76  (14.521) 65.25  (14.411) 65.21  (19.489) 59.91  (10.833)
Day 43 Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
59.76  (8.724) 62.21  (13.266) 62.29  (15.415) 57.31  (13.936) 58.82  (10.450) 59.36  (14.950) 63.64  (15.435) 65.17  (18.846) 59.74  (10.558)
Day 50 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
60.12  (10.248) 60.04  (12.185) 62.09  (14.058) 57.81  (14.525) 58.55  (10.835) 59.40  (14.955) 64.91  (13.651) 65.21  (19.669) 59.39  (10.586)
Day 57 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
58.40  (8.221) 58.83  (13.830) 60.35  (13.231) 54.88  (12.745) 57.45  (10.804) 57.16  (12.589) 61.92  (14.374) 62.63  (20.549) 56.61  (10.782)
Day 71 Number Analyzed 24 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
60.29  (9.438) 62.96  (14.0492) 64.83  (16.854) 56.85  (12.069) 58.00  (9.798) 59.16  (13.539) 63.92  (14.185) 66.29  (20.354) 57.78  (9.662)
Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
58.24  (9.926) 59.54  (12.827) 59.70  (11.315) 53.96  (12.981) 59.77  (10.438) 55.04  (13.421) 63.09  (13.211) 62.00  (17.619) 56.35  (10.075)
Day 99 Number Analyzed 25 participants 24 participants 22 participants 25 participants 22 participants 25 participants 24 participants 24 participants 23 participants
62.68  (11.926) 62.54  (13.462) 62.32  (14.496) 59.92  (12.812) 60.36  (10.472) 60.00  (13.051) 64.54  (15.453) 64.63  (18.946) 59.30  (12.430)
Day 106 Number Analyzed 25 participants 24 participants 22 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
62.36  (11.489) 63.25  (15.118) 64.41  (13.355) 58.28  (12.651) 59.45  (10.117) 60.08  (15.231) 64.39  (15.718) 65.17  (18.897) 58.30  (11.703)
Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
58.13  (11.395) 61.04  (14.245) 59.39  (12.565) 55.28  (13.145) 60.32  (10.049) 57.92  (14.617) 63.00  (14.331) 61.83  (18.218) 56.17  (10.421)
Day 127 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
59.16  (12.212) 59.46  (13.552) 62.78  (14.013) 60.72  (15.118) 57.82  (9.272) 58.56  (13.818) 63.61  (16.160) 63.88  (19.161) 58.00  (10.838)
Day 141 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
60.58  (11.960) 60.63  (13.682) 64.26  (14.530) 60.96  (15.970) 59.09  (10.766) 59.40  (16.081) 63.26  (14.229) 64.00  (20.167) 62.39  (14.138)
Day 155 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 23 participants 23 participants 24 participants 23 participants
58.72  (10.620) 59.00  (14.341) 61.96  (14.455) 59.48  (14.535) 59.45  (9.179) 59.04  (16.425) 63.00  (15.021) 63.67  (20.550) 61.87  (13.602)
Day 169 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 24 participants 23 participants 23 participants 22 participants
57.48  (11.794) 59.04  (12.726) 62.48  (14.441) 61.88  (15.078) 60.50  (11.827) 60.29  (16.206) 62.04  (15.155) 65.00  (24.355) 65.05  (13.584)
21.Secondary Outcome
Title Change From Baseline in High Density Lipoprotein- Cholesterol (HDL-C) at Day 85 and Day 113
Hide Description HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time Frame Baseline, Day 85, 113
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: mg/dL
Change at Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
3.66  (6.216) 4.79  (5.568) 2.63  (5.394) -4.58  (4.573) 2.80  (6.223) -2.18  (6.065) 1.46  (7.408) -0.02  (7.575) -4.52  (5.191)
Change at Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
3.90  (6.437) 6.29  (7.003) 2.33  (8.053) -3.28  (7.264) 3.34  (5.702) 0.70  (6.489) 1.37  (7.799) -0.63  (6.995) -4.70  (5.045)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 7.663
Confidence Interval (2-Sided) 95%
4.820 to 10.506
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.431
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 9.290
Confidence Interval (2-Sided) 95%
6.389 to 12.190
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.460
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 7.255
Confidence Interval (2-Sided) 95%
4.336 to 10.175
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.470
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.110
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 2.228
Confidence Interval (2-Sided) 95%
-1.361 to 5.818
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.806
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 5.578
Confidence Interval (2-Sided) 95%
1.972 to 9.185
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.815
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 4.712
Confidence Interval (2-Sided) 95%
1.156 to 8.268
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.789
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 5.888
Confidence Interval (2-Sided) 95%
1.844 to 9.932
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.035
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 9.251
Confidence Interval (2-Sided) 95%
5.153 to 13.349
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.062
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 5.264
Confidence Interval (2-Sided) 95%
1.147 to 9.380
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.072
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 5.065
Confidence Interval (2-Sided) 95%
1.402 to 8.728
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.843
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 5.096
Confidence Interval (2-Sided) 95%
1.413 to 8.780
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.853
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 4.301
Confidence Interval (2-Sided) 95%
0.658 to 7.943
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.832
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Percent Change From Baseline in High Density Lipoprotein- Cholesterol (HDL-C) at Day 85 and Day 113
Hide Description HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Time Frame Baseline, Day 85, 113
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: percent change
Change at Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
7.26  (10.914) 9.46  (11.132) 5.86  (9.988) -7.31  (7.254) 5.42  (10.501) -3.10  (10.471) 2.93  (11.259) 2.35  (12.101) -7.16  (8.271)
Change at Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
7.39  (11.623) 11.97  (13.385) 5.27  (12.612) -4.83  (9.919) 6.31  (9.989) 1.86  (11.617) 2.35  (10.959) 1.05  (10.017) -7.53  (7.966)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 13.389
Confidence Interval (2-Sided) 95%
8.373 to 18.405
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.525
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 16.546
Confidence Interval (2-Sided) 95%
11.430 to 21.663
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.576
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 13.288
Confidence Interval (2-Sided) 95%
8.137 to 18.438
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.593
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.081
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 4.112
Confidence Interval (2-Sided) 95%
-1.671 to 9.895
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.909
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 9.560
Confidence Interval (2-Sided) 95%
3.743 to 15.377
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.927
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 9.826
Confidence Interval (2-Sided) 95%
4.103 to 15.548
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.878
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 10.004
Confidence Interval (2-Sided) 95%
3.395 to 16.612
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.326
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 16.252
Confidence Interval (2-Sided) 95%
9.560 to 22.943
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.367
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 9.571
Confidence Interval (2-Sided) 95%
2.847 to 16.295
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.384
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 9.029
Confidence Interval (2-Sided) 95%
3.348 to 14.710
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.858
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 8.543
Confidence Interval (2-Sided) 95%
2.827 to 14.260
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.876
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 8.898
Confidence Interval (2-Sided) 95%
3.252 to 14.544
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.840
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Very Low Density Lipoprotein-Cholesterol (VLDL-C)
Hide Description VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time Frame Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
19.92  (9.312) 23.79  (11.286) 20.92  (7.651) 21.42  (6.858) 22.48  (7.869) 17.44  (7.509) 17.66  (9.090) 16.63  (6.273) 17.50  (8.549)
Day 5 Number Analyzed 25 participants 23 participants 23 participants 26 participants 22 participants 25 participants 25 participants 24 participants 22 participants
21.36  (9.999) 19.70  (8.249) 17.22  (5.977) 23.85  (10.657) 21.95  (8.249) 19.80  (11.927) 16.08  (8.356) 18.00  (10.065) 20.68  (10.035)
Day 8 Number Analyzed 25 participants 24 participants 24 participants 25 participants 21 participants 25 participants 24 participants 22 participants 23 participants
19.64  (13.073) 18.00  (6.574) 15.58  (6.192) 21.72  (10.577) 20.29  (7.100) 18.64  (9.995) 16.25  (6.661) 18.95  (9.810) 22.48  (13.737)
Day 15 Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
17.20  (8.921) 20.42  (9.930) 16.50  (9.869) 23.04  (9.035) 22.68  (9.712) 18.52  (9.265) 16.28  (8.735) 16.25  (10.605) 20.43  (10.612)
Day 22 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
17.04  (6.761) 19.04  (7.410) 14.65  (6.786) 21.65  (7.573) 21.59  (7.866) 17.20  (7.984) 16.42  (6.580) 17.17  (14.199) 18.13  (9.416)
Day 29 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 25 participants 25 participants 24 participants 22 participants
15.76  (7.253) 19.88  (9.967) 15.39  (4.717) 21.88  (9.523) 22.73  (10.552) 17.00  (7.746) 19.68  (16.106) 13.04  (6.753) 19.00  (8.258)
Day 36 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
18.96  (9.361) 15.33  (4.984) 14.04  (5.842) 21.92  (9.587) 21.59  (9.169) 17.28  (6.901) 16.46  (6.129) 15.50  (5.905) 24.22  (17.231)
Day 43 Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
16.56  (6.246) 21.33  (13.770) 18.04  (10.813) 23.65  (12.547) 20.95  (7.712) 20.00  (7.708) 18.12  (7.316) 16.96  (6.734) 22.78  (11.631)
Day 50 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
16.36  (9.269) 17.67  (6.787) 14.39  (6.966) 21.69  (11.235) 19.23  (6.718) 17.48  (8.186) 17.04  (7.151) 15.54  (7.818) 22.26  (13.685)
Day 57 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
14.36  (6.034) 17.46  (8.939) 13.87  (4.674) 20.88  (7.957) 21.55  (5.878) 15.44  (5.108) 16.83  (12.437) 13.54  (4.222) 20.13  (10.092)
Day 71 Number Analyzed 24 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
15.92  (7.064) 17.50  (9.212) 13.83  (3.950) 21.77  (9.868) 20.82  (8.151) 19.04  (6.846) 16.79  (6.840) 14.63  (6.337) 22.61  (9.014)
Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
14.24  (6.247) 17.63  (8.816) 14.04  (6.745) 22.58  (7.991) 19.77  (5.936) 16.68  (7.040) 14.09  (6.735) 14.04  (4.639) 16.43  (8.877)
Day 99 Number Analyzed 25 participants 24 participants 22 participants 25 participants 22 participants 25 participants 24 participants 24 participants 23 participants
16.20  (6.371) 18.04  (10.378) 18.68  (17.700) 21.72  (11.085) 20.14  (7.298) 17.84  (6.756) 16.46  (9.514) 16.21  (8.490) 21.13  (8.981)
Day 106 Number Analyzed 25 participants 24 participants 22 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
14.44  (6.545) 15.96  (6.328) 14.59  (5.981) 19.32  (7.330) 18.64  (6.499) 17.76  (7.573) 16.09  (5.672) 13.13  (5.788) 20.00  (9.376)
Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
15.83  (8.726) 16.54  (7.863) 15.26  (5.056) 21.88  (14.701) 18.50  (7.951) 15.92  (8.246) 15.96  (8.466) 13.87  (6.107) 19.39  (8.322)
Day 127 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
20.48  (11.594) 23.21  (14.231) 16.61  (7.686) 19.32  (9.534) 21.59  (7.992) 19.72  (8.091) 17.91  (11.445) 17.38  (12.631) 21.61  (13.121)
Day 141 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
18.13  (7.279) 22.25  (15.109) 17.39  (5.007) 19.16  (9.573) 23.68  (9.564) 19.52  (10.627) 17.61  (7.518) 18.54  (9.913) 20.09  (9.409)
Day 155 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 23 participants 23 participants 24 participants 23 participants
17.00  (3.905) 22.21  (11.858) 16.52  (7.141) 20.56  (9.319) 21.41  (7.028) 19.30  (9.632) 16.17  (8.144) 18.92  (10.738) 18.57  (9.110)
Day 169 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 24 participants 23 participants 23 participants 22 participants
18.88  (7.732) 21.42  (7.442) 17.30  (6.292) 19.60  (7.286) 24.55  (11.931) 19.13  (8.644) 23.00  (23.279) 18.00  (10.167) 19.68  (8.306)
24.Secondary Outcome
Title Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Day 85 and Day 113
Hide Description VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time Frame Baseline, Day 85, 113
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: mg/dL
Change at Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
-5.68  (6.973) -6.17  (7.171) -6.57  (6.726) 1.15  (4.841) -2.70  (7.069) -0.76  (5.114) -2.63  (9.497) -2.58  (7.290) -1.07  (4.989)
Change at Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
-4.29  (8.538) -7.25  (9.067) -5.35  (6.619) 0.34  (10.957) -3.98  (8.873) -1.52  (5.771) -0.76  (9.276) -2.98  (6.998) 1.89  (5.762)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -7.462
Confidence Interval (2-Sided) 95%
-10.311 to -4.614
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.434
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -6.693
Confidence Interval (2-Sided) 95%
-9.610 to -3.776
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.469
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -8.755
Confidence Interval (2-Sided) 95%
-11.692 to -5.817
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.479
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.484
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -0.072
Confidence Interval (2-Sided) 95%
-3.596 to 3.451
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.773
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.173
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -1.701
Confidence Interval (2-Sided) 95%
-5.264 to 1.862
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.793
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.135
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -1.953
Confidence Interval (2-Sided) 95%
-5.452 to 1.546
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.761
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -4.447
Confidence Interval (2-Sided) 95%
-9.230 to 0.335
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.406
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -6.764
Confidence Interval (2-Sided) 95%
-11.617 to -1.910
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.442
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -5.951
Confidence Interval (2-Sided) 95%
-10.836 to -1.066
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.458
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.056
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -3.070
Confidence Interval (2-Sided) 95%
-6.876 to 0.736
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.915
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.095
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -2.557
Confidence Interval (2-Sided) 95%
-6.408 to 1.293
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.937
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -5.271
Confidence Interval (2-Sided) 95%
-9.074 to -1.469
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.913
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Day 85 and Day 113
Hide Description VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Time Frame Baseline, Day 85, 113
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: percent change
Change at Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 24 participants 23 participants 24 participants 23 participants
-23.42  (30.458) -22.99  (25.647) -28.96  (25.281) 7.08  (26.054) -6.48  (27.276) -7.61  (23.163) 5.66  (76.931) -3.54  (45.821) -3.63  (39.826)
Change at Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 24 participants 23 participants 23 participants 23 participants
-17.23  (35.083) -26.62  (28.464) -19.28  (33.794) -1.89  (43.239) -10.80  (38.288) -9.72  (29.006) 10.72  (65.297) -10.36  (36.732) 18.73  (48.065)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -31.880
Confidence Interval (2-Sided) 95%
-45.925 to -17.836
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.071
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -29.187
Confidence Interval (2-Sided) 95%
-43.571 to -14.803
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.242
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -39.657
Confidence Interval (2-Sided) 95%
-54.136 to -25.178
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.290
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.366
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -4.681
Confidence Interval (2-Sided) 95%
-31.713 to 22.350
Parameter Dispersion
Type: Standard Error of the Mean
Value: 13.601
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.773
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 10.227
Confidence Interval (2-Sided) 95%
-16.774 to 37.228
Parameter Dispersion
Type: Standard Error of the Mean
Value: 13.586
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.422
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -2.646
Confidence Interval (2-Sided) 95%
-29.206 to 23.915
Parameter Dispersion
Type: Standard Error of the Mean
Value: 13.362
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.107
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -12.911
Confidence Interval (2-Sided) 95%
-33.411 to 7.589
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.309
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -23.119
Confidence Interval (2-Sided) 95%
-43.923 to -2.315
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.461
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.054
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -17.159
Confidence Interval (2-Sided) 95%
-38.108 to 3.789
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.535
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -24.416
Confidence Interval (2-Sided) 95%
-49.696 to 0.865
Parameter Dispersion
Type: Standard Error of the Mean
Value: 12.718
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.311
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -6.287
Confidence Interval (2-Sided) 95%
-31.541 to 18.968
Parameter Dispersion
Type: Standard Error of the Mean
Value: 12.705
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -32.443
Confidence Interval (2-Sided) 95%
-57.400 to -7.485
Parameter Dispersion
Type: Standard Error of the Mean
Value: 12.555
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Triglyceride (TG)
Hide Description Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time Frame Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
121.04  (56.152) 158.21  (71.477) 127.65  (59.878) 140.23  (51.283) 152.59  (50.105) 122.40  (50.578) 124.40  (59.717) 111.58  (42.354) 130.39  (49.826)
Day 5 Number Analyzed 25 participants 23 participants 23 participants 26 participants 22 participants 25 participants 25 participants 24 participants 22 participants
134.20  (78.692) 130.30  (58.718) 112.17  (47.884) 154.27  (74.707) 146.41  (76.274) 128.20  (79.256) 115.40  (52.401) 114.25  (61.969) 121.09  (48.602)
Day 8 Number Analyzed 25 participants 24 participants 24 participants 25 participants 21 participants 25 participants 24 participants 22 participants 23 participants
126.44  (123.041) 124.58  (49.786) 95.71  (42.796) 150.40  (76.908) 128.43  (50.155) 122.72  (66.459) 103.50  (48.515) 130.91  (75.156) 136.91  (91.378)
Day 15 Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
109.52  (65.672) 143.96  (70.871) 123.96  (108.066) 149.31  (64.392) 145.91  (79.420) 125.64  (55.667) 113.52  (60.601) 114.25  (54.003) 130.65  (53.724)
Day 22 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
105.56  (45.283) 119.17  (55.800) 101.96  (54.725) 133.65  (48.535) 144.64  (68.531) 125.00  (54.636) 109.04  (49.088) 113.79  (106.198) 130.26  (59.246)
Day 29 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 25 participants 25 participants 24 participants 22 participants
97.84  (49.164) 133.38  (74.370) 100.04  (39.343) 147.92  (68.536) 130.00  (52.743) 111.24  (46.683) 142.84  (141.763) 94.29  (37.698) 122.09  (49.749)
Day 36 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
113.68  (71.769) 111.25  (45.529) 96.52  (56.535) 154.65  (59.929) 139.95  (79.796) 115.12  (54.424) 109.17  (54.052) 105.67  (38.421) 158.30  (102.642)
Day 43 Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
108.16  (56.609) 161.75  (134.409) 130.71  (124.380) 159.19  (85.270) 135.23  (70.762) 123.80  (52.925) 119.44  (53.110) 109.29  (54.365) 140.61  (73.706)
Day 50 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
108.12  (65.442) 126.58  (56.883) 100.57  (52.553) 148.50  (77.558) 121.64  (51.406) 123.48  (61.199) 114.22  (53.090) 113.29  (53.870) 142.30  (83.014)
Day 57 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
94.40  (49.048) 124.25  (69.357) 92.52  (45.106) 139.50  (56.099) 137.55  (53.502) 102.28  (33.512) 117.21  (84.666) 90.67  (28.925) 136.78  (67.987)
Day 71 Number Analyzed 24 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
103.13  (51.243) 125.50  (74.428) 93.91  (39.340) 156.27  (65.687) 139.27  (85.017) 122.68  (52.192) 112.13  (56.034) 103.13  (47.534) 146.43  (64.368)
Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
92.36  (47.872) 130.25  (78.800) 95.00  (54.102) 142.81  (57.891) 142.45  (60.126) 118.64  (46.593) 100.04  (53.185) 99.92  (40.798) 119.17  (57.046)
Day 99 Number Analyzed 25 participants 24 participants 22 participants 25 participants 22 participants 25 participants 24 participants 24 participants 23 participants
110.56  (57.944) 128.25  (70.840) 131.32  (118.340) 156.84  (70.931) 137.82  (60.866) 122.96  (55.697) 118.17  (63.727) 115.08  (63.629) 133.91  (49.879)
Day 106 Number Analyzed 25 participants 24 participants 22 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
97.80  (46.662) 116.29  (50.480) 102.59  (50.880) 131.68  (55.816) 133.41  (68.902) 116.16  (55.618) 109.91  (45.304) 93.54  (38.520) 139.00  (53.142)
Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
101.58  (51.130) 112.88  (60.824) 94.39  (34.093) 141.64  (96.032) 129.14  (73.031) 111.72  (53.875) 116.26  (69.771) 101.43  (52.274) 136.61  (64.291)
Day 127 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
133.40  (71.046) 159.25  (101.582) 115.96  (63.954) 133.40  (66.304) 153.14  (62.304) 138.08  (60.533) 139.83  (103.182) 124.50  (86.402) 159.43  (89.130)
Day 141 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
115.13  (51.964) 164.79  (129.257) 123.39  (35.150) 131.08  (56.266) 156.27  (76.965) 135.80  (75.159) 119.91  (59.343) 129.13  (70.190) 137.35  (56.775)
Day 155 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 23 participants 23 participants 24 participants 23 participants
115.44  (39.459) 164.13  (102.919) 113.83  (43.209) 139.44  (65.901) 149.23  (68.510) 129.00  (70.010) 119.91  (61.088) 133.33  (81.100) 131.74  (62.736)
Day 169 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 24 participants 23 participants 23 participants 22 participants
120.76  (56.962) 151.63  (59.252) 122.43  (65.091) 149.40  (58.176) 167.91  (79.436) 126.67  (60.290) 166.22  (176.973) 128.26  (71.260) 125.41  (36.439)
27.Secondary Outcome
Title Change From Baseline in Triglyceride (TG) at Day 85 and Day 113
Hide Description Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time Frame Baseline, Day 85, 113
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: mg/dL
Change at Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
-28.68  (41.898) -27.96  (49.754) -29.52  (40.669) 2.58  (35.796) -10.14  (43.129) -3.76  (37.502) -15.87  (48.341) -11.67  (42.519) -11.22  (23.797)
Change at Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
-20.02  (41.197) -45.33  (53.285) -30.13  (48.592) -0.58  (63.896) -23.45  (51.443) -10.68  (27.488) 0.35  (48.858) -12.46  (44.128) 6.22  (32.888)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -35.967
Confidence Interval (2-Sided) 95%
-57.463 to -14.472
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.822
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -29.186
Confidence Interval (2-Sided) 95%
-51.123 to -7.249
Parameter Dispersion
Type: Standard Error of the Mean
Value: 11.044
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -40.010
Confidence Interval (2-Sided) 95%
-62.175 to -17.845
Parameter Dispersion
Type: Standard Error of the Mean
Value: 11.160
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.614
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 3.170
Confidence Interval (2-Sided) 95%
-18.502 to 24.842
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.906
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.221
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -8.563
Confidence Interval (2-Sided) 95%
-30.554 to 13.427
Parameter Dispersion
Type: Standard Error of the Mean
Value: 11.067
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.303
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -5.649
Confidence Interval (2-Sided) 95%
-27.376 to 16.079
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.933
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.067
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -22.003
Confidence Interval (2-Sided) 95%
-50.882 to 6.875
Parameter Dispersion
Type: Standard Error of the Mean
Value: 14.530
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -41.761
Confidence Interval (2-Sided) 95%
-70.934 to -12.588
Parameter Dispersion
Type: Standard Error of the Mean
Value: 14.676
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -34.933
Confidence Interval (2-Sided) 95%
-64.410 to -5.456
Parameter Dispersion
Type: Standard Error of the Mean
Value: 14.832
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.064
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -17.978
Confidence Interval (2-Sided) 95%
-41.282 to 5.326
Parameter Dispersion
Type: Standard Error of the Mean
Value: 11.725
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.318
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -5.654
Confidence Interval (2-Sided) 95%
-29.311 to 18.004
Parameter Dispersion
Type: Standard Error of the Mean
Value: 11.903
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -19.435
Confidence Interval (2-Sided) 95%
-42.902 to 4.032
Parameter Dispersion
Type: Standard Error of the Mean
Value: 11.807
Estimation Comments [Not Specified]
28.Secondary Outcome
Title Percent Change From Baseline in Triglyceride (TG) at Day 85 and Day 113
Hide Description Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Time Frame Baseline, Day 85, 113
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: percent change
Change at Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
-21.00  (31.109) -16.85  (28.672) -23.38  (24.421) 3.74  (27.803) -5.20  (23.919) 2.62  (33.715) -9.40  (42.868) -5.21  (35.698) -9.33  (19.235)
Change at Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
-14.44  (26.916) -27.65  (26.827) -17.70  (29.263) -3.82  (36.247) -15.23  (24.917) -8.31  (19.500) 1.32  (37.694) -8.47  (35.865) 4.57  (29.077)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -25.974
Confidence Interval (2-Sided) 95%
-41.217 to -10.731
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.674
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -21.110
Confidence Interval (2-Sided) 95%
-36.665 to -5.555
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.831
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -31.034
Confidence Interval (2-Sided) 95%
-46.758 to -15.310
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.917
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.799
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 8.034
Confidence Interval (2-Sided) 95%
-10.948 to 27.015
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.553
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.398
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -2.511
Confidence Interval (2-Sided) 95%
-21.748 to 16.727
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.682
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.515
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.369
Confidence Interval (2-Sided) 95%
-18.668 to 19.407
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.580
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.128
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -10.056
Confidence Interval (2-Sided) 95%
-27.549 to 7.437
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.801
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -24.352
Confidence Interval (2-Sided) 95%
-42.008 to -6.695
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.882
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -14.994
Confidence Interval (2-Sided) 95%
-32.858 to 2.870
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.987
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.071
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -13.830
Confidence Interval (2-Sided) 95%
-32.368 to 4.709
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.326
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.361
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -3.378
Confidence Interval (2-Sided) 95%
-22.191 to 15.435
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.464
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.056
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -15.035
Confidence Interval (2-Sided) 95%
-33.698 to 3.629
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.389
Estimation Comments [Not Specified]
29.Secondary Outcome
Title Non-High Density Lipoprotein- Cholesterol (Non-HDL-C)
Hide Description Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time Frame Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
159.58  (29.033) 155.54  (20.706) 154.71  (22.511) 163.90  (25.271) 165.86  (26.655) 188.72  (30.222) 182.86  (22.842) 182.17  (21.217) 181.17  (23.577)
Day 5 Number Analyzed 25 participants 23 participants 23 participants 26 participants 22 participants 25 participants 25 participants 24 participants 22 participants
113.52  (28.259) 97.78  (25.034) 98.48  (15.003) 161.23  (22.059) 140.77  (26.324) 154.36  (35.666) 143.24  (23.520) 137.50  (28.770) 189.36  (24.432)
Day 8 Number Analyzed 25 participants 24 participants 24 participants 25 participants 21 participants 25 participants 24 participants 22 participants 23 participants
93.24  (22.966) 79.33  (27.140) 76.17  (15.222) 162.16  (29.067) 131.52  (23.712) 142.84  (36.478) 123.25  (25.378) 122.73  (29.183) 193.70  (20.424)
Day 15 Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
95.68  (27.248) 77.88  (27.299) 57.96  (16.134) 162.35  (20.558) 130.27  (19.489) 138.40  (38.794) 103.16  (26.742) 99.13  (22.099) 191.61  (22.845)
Day 22 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
69.92  (23.315) 58.92  (23.638) 48.26  (10.037) 160.04  (19.838) 130.59  (24.595) 115.36  (37.861) 88.71  (24.172) 88.29  (28.964) 192.09  (18.757)
Day 29 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 25 participants 25 participants 24 participants 22 participants
81.08  (26.644) 71.79  (26.662) 51.09  (14.820) 159.16  (20.163) 133.41  (30.589) 115.52  (38.434) 90.68  (25.610) 82.46  (20.659) 192.59  (23.425)
Day 36 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
66.20  (21.848) 53.38  (22.329) 44.96  (10.598) 159.46  (25.221) 129.32  (29.451) 103.72  (37.651) 81.83  (15.898) 79.42  (26.345) 184.74  (25.913)
Day 43 Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
79.64  (23.937) 66.63  (30.685) 51.46  (14.926) 157.31  (16.790) 132.05  (29.005) 112.60  (37.446) 88.16  (23.005) 82.08  (27.547) 194.30  (22.876)
Day 50 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
59.92  (17.814) 52.58  (21.847) 45.65  (11.276) 157.62  (22.608) 130.64  (25.964) 101.60  (36.427) 80.30  (20.448) 78.96  (27.207) 186.70  (20.220)
Day 57 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
75.76  (23.552) 58.13  (23.709) 44.26  (9.186) 153.15  (19.601) 126.68  (28.919) 101.80  (35.249) 86.08  (30.679) 73.21  (24.568) 180.17  (17.167)
Day 71 Number Analyzed 24 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
81.83  (28.164) 58.08  (26.357) 48.65  (13.110) 161.54  (22.089) 134.91  (30.239) 115.48  (36.001) 82.25  (22.283) 76.13  (22.793) 185.96  (28.798)
Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
77.28  (25.268) 60.04  (23.665) 49.87  (24.464) 154.92  (22.289) 139.05  (36.247) 110.40  (30.783) 78.00  (27.144) 72.17  (18.874) 175.17  (24.398)
Day 99 Number Analyzed 25 participants 24 participants 22 participants 25 participants 22 participants 25 participants 24 participants 24 participants 23 participants
88.56  (28.234) 66.04  (29.895) 60.05  (35.754) 156.36  (18.830) 133.68  (34.790) 118.36  (32.875) 85.29  (30.599) 74.50  (19.496) 190.52  (20.551)
Day 106 Number Analyzed 25 participants 24 participants 22 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
64.04  (24.315) 51.50  (23.178) 54.14  (28.648) 154.08  (19.378) 130.82  (29.301) 107.76  (31.232) 77.87  (23.470) 74.75  (22.115) 183.35  (19.664)
Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
82.50  (24.128) 63.54  (25.086) 55.78  (27.153) 146.36  (23.787) 131.41  (32.515) 111.80  (30.993) 83.00  (27.632) 72.35  (20.232) 180.65  (16.489)
Day 127 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
134.80  (24.100) 117.42  (37.408) 85.09  (41.318) 158.60  (22.504) 163.36  (33.835) 164.60  (38.791) 113.13  (46.332) 102.75  (33.666) 191.78  (28.623)
Day 141 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
149.17  (29.556) 142.08  (32.188) 119.83  (42.083) 155.52  (20.490) 170.41  (37.185) 187.96  (41.528) 154.17  (45.140) 128.96  (44.304) 191.09  (24.978)
Day 155 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 23 participants 23 participants 24 participants 23 participants
149.60  (26.876) 144.83  (26.836) 133.30  (30.526) 161.80  (21.960) 169.41  (37.377) 190.96  (34.453) 164.83  (34.193) 144.58  (40.902) 184.48  (18.030)
Day 169 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 24 participants 23 participants 23 participants 22 participants
155.48  (28.791) 153.75  (25.535) 148.52  (27.770) 159.12  (20.961) 174.45  (41.877) 193.88  (33.789) 183.52  (37.346) 162.65  (40.341) 193.59  (17.816)
30.Secondary Outcome
Title Change From Baseline in Non-High Density Lipoprotein- Cholesterol (Non-HDL-C) at Day 85 and Day 113
Hide Description Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time Frame Baseline, Day 85, 113
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: mg/dL
Change at Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
-82.30  (30.323) -95.50  (32.345) -104.07  (27.573) -8.98  (20.888) -26.82  (28.796) -78.32  (33.436) -104.26  (34.056) -110.00  (24.274) -6.00  (24.009)
Change at Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
-77.33  (22.371) -92.00  (32.099) -98.15  (28.798) -18.40  (22.784) -34.45  (26.242) -76.92  (35.588) -99.26  (27.347) -111.33  (24.646) -0.52  (20.267)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -76.189
Confidence Interval (2-Sided) 95%
-86.975 to -65.403
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.431
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -95.205
Confidence Interval (2-Sided) 95%
-106.238 to -84.172
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.556
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -106.077
Confidence Interval (2-Sided) 95%
-117.239 to -94.915
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.622
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -71.234
Confidence Interval (2-Sided) 95%
-84.390 to -58.077
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.622
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -100.638
Confidence Interval (2-Sided) 95%
-113.768 to -87.508
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.609
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -103.386
Confidence Interval (2-Sided) 95%
-116.353 to -90.420
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.525
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -61.124
Confidence Interval (2-Sided) 95%
-71.813 to -50.435
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.382
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -81.837
Confidence Interval (2-Sided) 95%
-92.721 to -70.954
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.480
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -89.683
Confidence Interval (2-Sided) 95%
-100.740 to -78.627
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.567
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -76.747
Confidence Interval (2-Sided) 95%
-88.902 to -64.593
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.118
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -100.666
Confidence Interval (2-Sided) 95%
-112.781 to -88.551
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.098
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -109.490
Confidence Interval (2-Sided) 95%
-121.519 to -97.462
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.054
Estimation Comments [Not Specified]
31.Secondary Outcome
Title Percent Change From Baseline in Non-High Density Lipoprotein- Cholesterol (Non-HDL-C) at Day 85 and Day 113
Hide Description Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Time Frame Baseline, Day 85, 113
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: percent change
Change at Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
-50.98  (15.662) -60.62  (17.746) -67.69  (14.462) -4.77  (11.716) -16.20  (16.334) -41.11  (16.193) -56.87  (14.745) -60.17  (10.493) -2.49  (12.951)
Change at Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
-48.56  (12.284) -58.57  (17.970) -63.92  (15.872) -10.59  (11.977) -20.67  (15.155) -40.19  (17.244) -54.54  (13.671) -60.43  (11.070) 0.88  (13.236)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -46.772
Confidence Interval (2-Sided) 95%
-53.671 to -39.874
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.473
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -59.200
Confidence Interval (2-Sided) 95%
-66.257 to -52.143
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.554
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -66.868
Confidence Interval (2-Sided) 95%
-74.007 to -59.730
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.595
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -40.051
Confidence Interval (2-Sided) 95%
-47.195 to -32.908
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.595
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -56.009
Confidence Interval (2-Sided) 95%
-63.135 to -48.882
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.587
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -57.576
Confidence Interval (2-Sided) 95%
-64.618 to -50.533
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.544
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -37.991
Confidence Interval (2-Sided) 95%
-44.721 to -31.260
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.389
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -50.856
Confidence Interval (2-Sided) 95%
-57.709 to -44.002
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.451
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -56.354
Confidence Interval (2-Sided) 95%
-63.315 to -49.393
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.505
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -43.172
Confidence Interval (2-Sided) 95%
-50.417 to -35.926
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.647
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -56.698
Confidence Interval (2-Sided) 95%
-63.916 to -49.480
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.633
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -61.305
Confidence Interval (2-Sided) 95%
-68.477 to -54.134
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.609
Estimation Comments [Not Specified]
32.Secondary Outcome
Title Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio
Hide Description Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time Frame Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: ratio
Baseline Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
4.0118  (0.82813) 4.0154  (0.92478) 3.8500  (0.72414) 3.9629  (0.77435) 4.0223  (0.81145) 4.5408  (1.11809) 4.2558  (1.15512) 4.2610  (1.08481) 4.1076  (0.88524)
Day 5 Number Analyzed 25 participants 23 participants 23 participants 26 participants 22 participants 25 participants 25 participants 24 participants 22 participants
3.1372  (0.81529) 2.7861  (0.57451) 2.7500  (0.38981) 3.9465  (0.83527) 3.5668  (0.77085) 3.9264  (1.11497) 3.5036  (0.76250) 3.4029  (0.86267) 4.3259  (0.99932)
Day 8 Number Analyzed 25 participants 24 participants 24 participants 25 participants 21 participants 25 participants 24 participants 22 participants 23 participants
2.7252  (0.63762) 2.4100  (0.53023) 2.3083  (0.33483) 3.8588  (0.92894) 3.3510  (0.79979) 3.6024  (1.07004) 3.1367  (0.80233) 3.0941  (0.80907) 4.3374  (0.88617)
Day 15 Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
2.6884  (0.58429) 2.3754  (0.62550) 1.9658  (0.33815) 3.9308  (0.89274) 3.2700  (0.68229) 3.4940  (1.02033) 2.7772  (0.71059) 2.6050  (0.53948) 4.3017  (0.84316)
Day 22 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
2.2428  (0.53640) 2.0258  (0.49301) 1.7730  (0.18504) 3.8915  (0.75155) 3.2550  (0.66627) 3.0676  (0.92151) 2.4338  (0.43218) 2.3617  (0.35946) 4.2822  (0.97569)
Day 29 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 25 participants 25 participants 24 participants 22 participants
2.4020  (0.54386) 2.2533  (0.64125) 1.8296  (0.26896) 3.8852  (0.73498) 3.3318  (0.70099) 3.0260  (0.77510) 2.5780  (0.75738) 2.2800  (0.37240) 4.1023  (0.81890)
Day 36 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
2.1924  (0.45842) 1.9300  (0.46830) 1.7404  (0.18627) 3.9496  (0.92977) 3.2882  (0.68375) 2.8452  (0.78785) 2.3000  (0.31095) 2.2529  (0.39114) 4.2222  (0.97022)
Day 43 Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
2.3688  (0.48338) 2.1396  (0.61972) 1.8754  (0.39255) 3.9338  (0.87409) 3.3259  (0.70739) 3.0044  (0.77172) 2.5124  (0.80082) 2.3004  (0.42044) 4.4074  (1.03394)
Day 50 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
2.0280  (0.36876) 1.9254  (0.48864) 1.7443  (0.15406) 3.9419  (0.98670) 3.3277  (0.71213) 2.8300  (0.81738) 2.2883  (0.38697) 2.2658  (0.43915) 4.2909  (0.97014)
Day 57 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
2.3148  (0.44657) 2.0758  (0.63508) 1.7448  (0.12638) 3.9596  (0.84943) 3.2632  (0.60608) 2.8436  (0.67094) 2.5708  (1.24941) 2.2225  (0.37721) 4.3361  (0.97295)
Day 71 Number Analyzed 24 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
2.3925  (0.57023) 1.9988  (0.56686) 1.7709  (0.19489) 4.0085  (0.93120) 3.3855  (0.64850) 3.0528  (0.77095) 2.3258  (0.34951) 2.1988  (0.36789) 4.3791  (1.15180)
Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
2.3724  (0.52972) 2.0721  (0.54913) 1.8561  (0.49386) 4.0508  (0.91154) 3.3986  (0.73940) 3.1204  (0.72628) 2.2796  (0.46691) 2.2142  (0.37394) 4.2613  (1.08945)
Day 99 Number Analyzed 25 participants 24 participants 22 participants 25 participants 22 participants 25 participants 24 participants 24 participants 23 participants
2.4564  (0.54658) 2.1417  (0.70783) 2.0305  (0.76914) 3.7648  (0.83515) 3.3073  (0.81497) 3.0868  (0.75654) 2.4075  (0.70042) 2.2121  (0.37358) 4.4200  (1.15874)
Day 106 Number Analyzed 25 participants 24 participants 22 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
2.0476  (0.40004) 1.8650  (0.50620) 1.8814  (0.56847) 3.7912  (0.78337) 3.2832  (0.72097) 2.9176  (0.75101) 2.2517  (0.37291) 2.1896  (0.37808) 4.3157  (1.01377)
Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
2.4688  (0.50001) 2.1042  (0.55015) 1.9691  (0.52016) 3.8248  (0.91875) 3.2359  (0.65683) 3.0760  (0.78321) 2.3639  (0.45213) 2.2335  (0.42128) 4.3570  (0.88681)
Day 127 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
3.3776  (0.67839) 3.1533  (0.98795) 2.4822  (0.91213) 3.7984  (0.90030) 3.9132  (0.79683) 3.9896  (0.99046) 2.9087  (0.92317) 2.8208  (1.08222) 4.4717  (1.06069)
Day 141 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
3.5433  (0.67339) 3.5242  (0.96281) 3.0078  (0.91134) 3.7508  (0.88092) 3.9841  (0.87530) 4.4256  (1.20555) 3.6070  (1.06034) 3.3500  (1.37776) 4.2843  (1.17378)
Day 155 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 23 participants 23 participants 24 participants 23 participants
3.6240  (0.63587) 3.6392  (0.92468) 3.2748  (0.76307) 3.9100  (0.92453) 3.9205  (0.79163) 4.5057  (1.18175) 3.8126  (0.99748) 3.6450  (1.45582) 4.1804  (1.03516)
Day 169 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 24 participants 23 participants 23 participants 22 participants
3.8140  (0.77275) 3.7471  (0.82852) 3.4830  (0.67010) 3.7436  (0.86236) 4.0036  (0.99761) 4.4975  (1.25117) 4.2000  (1.23292) 3.8970  (1.40230) 4.1182  (0.81436)
33.Secondary Outcome
Title Change From Baseline in Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio at Day 85 and Day 113
Hide Description Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time Frame Baseline, Day 85, 113
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: ratio
Change at Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
-1.6394  (0.69058) -1.9433  (0.90358) -1.9835  (0.78766) 0.0879  (0.43755) -0.6236  (0.66072) -1.4204  (0.91892) -1.8407  (0.85260) -2.0469  (0.96230) 0.1537  (0.47755)
Change at Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
-1.5671  (0.65875) -1.9113  (0.93385) -1.8704  (0.73630) -0.1560  (0.53286) -0.7864  (0.60966) -1.4648  (0.83864) -1.7563  (0.74752) -2.0461  (0.92038) 0.2493  (0.43772)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -1.69928
Confidence Interval (2-Sided) 95%
-1.96175 to -1.43682
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13216
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -2.07922
Confidence Interval (2-Sided) 95%
-2.34622 to -1.81223
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13446
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -2.23886
Confidence Interval (2-Sided) 95%
-2.50795 to -1.96978
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13553
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -1.43281
Confidence Interval (2-Sided) 95%
-1.75689 to -1.10872
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.16311
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -2.01501
Confidence Interval (2-Sided) 95%
-2.33718 to -1.69283
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.16217
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -2.11359
Confidence Interval (2-Sided) 95%
-2.43230 to -1.79489
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.16038
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -1.35298
Confidence Interval (2-Sided) 95%
-1.62324 to -1.08271
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13609
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -1.79615
Confidence Interval (2-Sided) 95%
-2.07001 to -1.52229
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13790
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -1.86921
Confidence Interval (2-Sided) 95%
-2.14575 to -1.59266
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13927
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -1.57311
Confidence Interval (2-Sided) 95%
-1.85788 to -1.28834
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14333
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -2.00256
Confidence Interval (2-Sided) 95%
-2.28521 to -1.71990
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14228
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -2.20298
Confidence Interval (2-Sided) 95%
-2.48399 to -1.92197
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14142
Estimation Comments [Not Specified]
34.Secondary Outcome
Title Percent Change From Baseline in Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio at Day 85 and Day 113
Hide Description Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Time Frame Baseline, Day 85, 113
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: percent change
Change at Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
-39.99  (12.892) -47.06  (15.152) -50.43  (13.358) 2.19  (10.328) -14.65  (14.740) -29.51  (16.200) -43.25  (12.569) -45.74  (11.961) 3.81  (10.643)
Change at Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
-38.20  (10.463) -46.04  (15.705) -47.68  (13.195) -3.81  (12.537) -18.57  (13.541) -31.07  (14.770) -41.49  (10.520) -45.65  (12.114) 6.98  (12.436)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -41.92915
Confidence Interval (2-Sided) 95%
-47.55052 to -36.30778
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.83037
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -51.08604
Confidence Interval (2-Sided) 95%
-56.81235 to -45.35973
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.88356
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -55.51600
Confidence Interval (2-Sided) 95%
-61.29424 to -49.73777
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.91014
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -33.30375
Confidence Interval (2-Sided) 95%
-39.41376 to -27.19373
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.07498
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -47.85210
Confidence Interval (2-Sided) 95%
-53.92668 to -41.77751
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.05746
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -48.65686
Confidence Interval (2-Sided) 95%
-54.66060 to -42.65313
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.02097
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -33.52920
Confidence Interval (2-Sided) 95%
-39.42015 to -27.63826
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.96599
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -43.85680
Confidence Interval (2-Sided) 95%
-49.82617 to -37.88744
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.00531
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -46.36865
Confidence Interval (2-Sided) 95%
-52.40589 to -40.33142
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.03981
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -38.06019
Confidence Interval (2-Sided) 95%
-44.29176 to -31.82863
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.13610
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -48.57807
Confidence Interval (2-Sided) 95%
-54.76397 to -42.39217
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.11350
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -51.87214
Confidence Interval (2-Sided) 95%
-58.01968 to -45.72460
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.09363
Estimation Comments [Not Specified]
35.Secondary Outcome
Title Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio
Hide Description Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Time Frame Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: ratio
Baseline Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
0.6846  (0.14145) 0.6606  (0.13665) 0.6567  (0.12772) 0.6687  (0.12269) 0.6775  (0.14076) 0.7890  (0.17841) 0.7324  (0.16556) 0.7167  (0.16058) 0.6980  (0.13867)
Day 5 Number Analyzed 25 participants 23 participants 23 participants 26 participants 22 participants 25 participants 25 participants 24 participants 22 participants
0.4896  (0.14794) 0.4135  (0.11264) 0.4222  (0.07116) 0.6612  (0.12682) 0.5968  (0.14211) 0.6428  (0.18885) 0.5792  (0.11372) 0.5300  (0.11967) 0.7100  (0.12642)
Day 8 Number Analyzed 25 participants 24 participants 24 participants 25 participants 21 participants 25 participants 24 participants 22 participants 23 participants
0.4044  (0.09862) 0.3363  (0.11305) 0.3271  (0.06760) 0.6660  (0.14947) 0.5657  (0.14552) 0.5844  (0.18410) 0.5017  (0.12310) 0.4718  (0.13900) 0.7230  (0.11227)
Day 15 Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
0.4308  (0.12426) 0.3300  (0.12322) 0.2450  (0.05649) 0.6712  (0.13137) 0.5445  (0.11164) 0.5776  (0.16885) 0.4216  (0.11929) 0.3763  (0.08293) 0.7226  (0.13404)
Day 22 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
0.3136  (0.10610) 0.2463  (0.09668) 0.2078  (0.04572) 0.6773  (0.13012) 0.5564  (0.13347) 0.4868  (0.17148) 0.3629  (0.10897) 0.3283  (0.09220) 0.7248  (0.12409)
Day 29 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 25 participants 25 participants 24 participants 22 participants
0.3656  (0.12076) 0.3058  (0.12721) 0.2196  (0.05943) 0.6776  (0.12337) 0.5609  (0.11924) 0.4820  (0.14437) 0.3720  (0.11247) 0.3254  (0.07524) 0.7023  (0.11439)
Day 36 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
0.2900  (0.09278) 0.2421  (0.10206) 0.1983  (0.04376) 0.6873  (0.15278) 0.5600  (0.13551) 0.4428  (0.15255) 0.3250  (0.06093) 0.3050  (0.08900) 0.7048  (0.13413)
Day 43 Number Analyzed 25 participants 24 participants 24 participants 26 participants 22 participants 25 participants 25 participants 24 participants 23 participants
0.3592  (0.10723) 0.2800  (0.12399) 0.2142  (0.05012) 0.6788  (0.12944) 0.5805  (0.11978) 0.4696  (0.15115) 0.3632  (0.14522) 0.3188  (0.09124) 0.7548  (0.16351)
Day 50 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
0.2668  (0.07669) 0.2313  (0.10182) 0.2048  (0.04088) 0.6804  (0.13489) 0.5959  (0.13893) 0.4472  (0.16198) 0.3283  (0.08917) 0.3133  (0.09234) 0.7465  (0.13878)
Day 57 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
0.3584  (0.09715) 0.2642  (0.13319) 0.2026  (0.04081) 0.6938  (0.12747) 0.5682  (0.13297) 0.4616  (0.15220) 0.3804  (0.18286) 0.3196  (0.07765) 0.7630  (0.13394)
Day 71 Number Analyzed 24 participants 24 participants 23 participants 26 participants 22 participants 25 participants 24 participants 24 participants 23 participants
0.3692  (0.12402) 0.2592  (0.11602) 0.2157  (0.05281) 0.6958  (0.13840) 0.5986  (0.12434) 0.4976  (0.15592) 0.3358  (0.07678) 0.3146  (0.08086) 0.7500  (0.17328)
Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
0.3768  (0.11546) 0.2696  (0.11705) 0.2335  (0.10170) 0.7023  (0.13946) 0.6132  (0.16069) 0.5264  (0.14405) 0.3435  (0.11007) 0.3125  (0.08125) 0.7665  (0.18376)
Day 99 Number Analyzed 25 participants 24 participants 22 participants 25 participants 22 participants 25 participants 24 participants 24 participants 23 participants
0.3928  (0.12458) 0.2904  (0.12791) 0.2491  (0.12432) 0.6584  (0.13120) 0.5882  (0.15930) 0.5164  (0.15168) 0.3650  (0.15223) 0.3075  (0.07170) 0.7883  (0.18622)
Day 106 Number Analyzed 25 participants 24 participants 22 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
0.2908  (0.08450) 0.2267  (0.10925) 0.2405  (0.12187) 0.6716  (0.12925) 0.5877  (0.15253) 0.4796  (0.14386) 0.3322  (0.09130) 0.3142  (0.08230) 0.7730  (0.14455)
Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
0.3888  (0.10343) 0.2908  (0.11858) 0.2548  (0.10845) 0.6556  (0.14192) 0.5777  (0.12976) 0.5140  (0.15398) 0.3557  (0.10710) 0.3235  (0.08804) 0.7683  (0.14272)
Day 127 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
0.5772  (0.11473) 0.5029  (0.17571) 0.3778  (0.19064) 0.6692  (0.13546) 0.6950  (0.15732) 0.7024  (0.18033) 0.4730  (0.18425) 0.4325  (0.16469) 0.7830  (0.15893)
Day 141 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 24 participants 23 participants
0.6233  (0.12107) 0.5938  (0.15786) 0.5004  (0.19354) 0.6580  (0.13916) 0.7082  (0.17595) 0.7916  (0.20262) 0.6352  (0.20727) 0.5375  (0.23022) 0.7570  (0.17219)
Day 155 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 23 participants 23 participants 24 participants 23 participants
0.6368  (0.11957) 0.6125  (0.15224) 0.5574  (0.13288) 0.6664  (0.13225) 0.6991  (0.17124) 0.8148  (0.20102) 0.6839  (0.19315) 0.6075  (0.24120) 0.7452  (0.16318)
Day 169 Number Analyzed 25 participants 24 participants 23 participants 25 participants 22 participants 24 participants 23 participants 23 participants 22 participants
0.6640  (0.14350) 0.6321  (0.14774) 0.6161  (0.12493) 0.6424  (0.14621) 0.6845  (0.17986) 0.8088  (0.20105) 0.7178  (0.18178) 0.6639  (0.22661) 0.7359  (0.13397)
36.Secondary Outcome
Title Change From Baseline in Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio at Day 85 and Day 113
Hide Description Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Time Frame Baseline, Day 85, 113
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: ratio
Change at Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
-0.3078  (0.13144) -0.3910  (0.15635) -0.4211  (0.16147) 0.0337  (0.09054) -0.0643  (0.11318) -0.2626  (0.16341) -0.3748  (0.17224) -0.4042  (0.14894) 0.0685  (0.10818)
Change at Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
-0.2998  (0.12105) -0.3698  (0.16194) -0.3998  (0.15163) -0.0170  (0.10303) -0.0998  (0.09487) -0.2750  (0.15604) -0.3626  (0.14553) -0.3965  (0.15431) 0.0702  (0.09306)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -0.33157
Confidence Interval (2-Sided) 95%
-0.38399 to -0.27916
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02639
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -0.44402
Confidence Interval (2-Sided) 95%
-0.49727 to -0.39077
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02682
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -0.48314
Confidence Interval (2-Sided) 95%
-0.53671 to -0.42956
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02698
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -0.30542
Confidence Interval (2-Sided) 95%
-0.36960 to -0.24124
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.03230
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -0.44143
Confidence Interval (2-Sided) 95%
-0.50466 to -0.37821
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.03183
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -0.46235
Confidence Interval (2-Sided) 95%
-0.52491 to -0.39980
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.03148
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -0.26949
Confidence Interval (2-Sided) 95%
-0.32142 to -0.21755
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02615
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -0.37493
Confidence Interval (2-Sided) 95%
-0.42754 to -0.32231
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02649
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -0.41199
Confidence Interval (2-Sided) 95%
-0.46512 to -0.35886
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02676
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -0.31806
Confidence Interval (2-Sided) 95%
-0.37723 to -0.25888
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02979
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -0.42583
Confidence Interval (2-Sided) 95%
-0.48409 to -0.36758
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02932
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -0.45501
Confidence Interval (2-Sided) 95%
-0.51287 to -0.39715
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02912
Estimation Comments [Not Specified]
37.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio at Day 85 and Day 113
Hide Description Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Time Frame Baseline, Day 85, 113
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: percent change
Change at Day 85 Number Analyzed 25 participants 24 participants 23 participants 26 participants 22 participants 25 participants 23 participants 24 participants 23 participants
-44.37  (16.358) -58.47  (19.271) -63.09  (16.240) 5.51  (12.823) -9.13  (16.695) -32.09  (18.463) -50.97  (16.380) -55.16  (11.927) 10.41  (15.319)
Change at Day 113 Number Analyzed 24 participants 24 participants 23 participants 25 participants 22 participants 25 participants 23 participants 23 participants 23 participants
-43.21  (13.147) -55.05  (19.756) -60.32  (15.924) -2.03  (14.326) -14.00  (14.205) -34.11  (18.505) -49.84  (13.744) -53.65  (13.386) 11.47  (16.250)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -49.42411
Confidence Interval (2-Sided) 95%
-56.83019 to -42.01803
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.72907
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -66.63383
Confidence Interval (2-Sided) 95%
-74.16086 to -59.10681
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.79050
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -71.72901
Confidence Interval (2-Sided) 95%
-79.30431 to -64.15371
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.81541
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -43.56596
Confidence Interval (2-Sided) 95%
-51.35899 to -35.77293
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.92236
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -62.34926
Confidence Interval (2-Sided) 95%
-70.02607 to -54.67245
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.86432
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -65.06617
Confidence Interval (2-Sided) 95%
-72.65818 to -57.47415
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.82052
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 50 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -40.52435
Confidence Interval (2-Sided) 95%
-47.81299 to -33.23571
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.66973
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 100 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -56.14495
Confidence Interval (2-Sided) 95%
-63.52668 to -48.76322
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.71641
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Atorvastatin + PF-04950615 150 mg, Atorvastatin + PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -61.56370
Confidence Interval (2-Sided) 95%
-69.02510 to -54.10230
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.75690
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04950615 50 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -46.34109
Confidence Interval (2-Sided) 95%
-54.61427 to -38.06792
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.16385
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04950615 100 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -61.37890
Confidence Interval (2-Sided) 95%
-69.52338 to -53.23443
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.09957
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-04950615 150 mg, PF-04950615 Placebo
Comments Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -64.67274
Confidence Interval (2-Sided) 95%
-72.75728 to -56.58820
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.06866
Estimation Comments [Not Specified]
38.Secondary Outcome
Title Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 10, 25, 40, 70 and 100 Milligram Per Deciliter
Hide Description LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection.
Time Frame Baseline up to Day 113
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who were randomized and administered at least 1 dose of study treatment. The outcome measure was planned to be analyzed for all the reporting groups except Atorvastatin + Ezetimibe 10 mg.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 25 25 24 23
Measure Type: Number
Unit of Measure: percentage of participants
LDL-C <10 mg/dL 0.0 4.2 0.0 0.0 0.0 0.0 0.0 0.0
LDL-C <25 mg/dL 12.0 66.7 58.3 0.0 0.0 0.0 20.8 0.0
LDL-C <40 mg/dL 84.0 91.7 95.8 0.0 12.0 36.0 41.7 0.0
LDL-C <70 mg/dL 96.0 100.0 100.0 0.0 64.0 92.0 87.5 0.0
LDL-C <100 mg/dL 100.0 100.0 100.0 23.1 92.0 100.0 100.0 4.3
39.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)
Hide Description An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to Day 169 that were absent before treatment or that worsened relative to pretreatment state. Adverse events included treatment emergent injection site adverse events and any clinically significant abnormal laboratory value.
Time Frame Baseline up to Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized and non-randomized participants who were administered at least 1 dose of study treatment.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 22 25 25 24 23
Measure Type: Number
Unit of Measure: participants
AEs 17 16 13 13 5 16 16 15 11
SAEs 1 0 0 1 0 0 1 0 0
40.Secondary Outcome
Title Number of Participants With Anti-Drug Antibody (ADA) Response
Hide Description Participants tested positive for ADA response on at least one post-baseline visit were reported. Participants with ADA titer level >=6.23 for PF-04950615 were considered ADA positive.
Time Frame Baseline up to Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized and non-randomized participants who were administered at least 1 dose of study treatment. This outcome measure was planned to be analyzed for all the reporting groups except for Atorvastatin + Ezetimibe 10 mg.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 0 25 25 24 0
Measure Type: Number
Unit of Measure: participants
14 6 14 13 16 11
41.Secondary Outcome
Title Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04950615
Hide Description Area under the plasma concentration time-curve from time zero to end of dosing interval (tau). This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Time Frame Single dose (Day 1: pre-dose, 24, 48, 72, 96, 120, 144, 168 hour (hr) post-dose), Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 12 12 13 11 12 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: microgram*day per milliliter(mcg*day/mL)
Single dose Number Analyzed 12 participants 12 participants 13 participants 11 participants 12 participants 12 participants
32.98
(57%)
52.33
(49%)
77.11
(43%)
32.97
(42%)
51.49
(46%)
82.05
(45%)
Multiple dose Number Analyzed 10 participants 8 participants 8 participants 10 participants 11 participants 12 participants
63.54
(40%)
92.46
(127%)
242.5
(81%)
63.74
(57%)
136.6
(32%)
273.5
(100%)
42.Secondary Outcome
Title Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-04950615
Hide Description Area under the plasma concentration-time profile from time zero extrapolated to infinite time. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Time Frame Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 10 7 8 9 11 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg*day/mL
94.83
(46%)
176.9
(144%)
469.5
(90%)
111.7
(63%)
237.4
(41%)
248.4
(76%)
43.Secondary Outcome
Title Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04950615
Hide Description Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Time Frame Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, N signifies participants evaluable for this outcome measure.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 10 8 8 10 11 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg*day/mL
87.86
(49%)
140.3
(145%)
434.2
(91%)
96.32
(65%)
220.9
(39%)
486.7
(143%)
44.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of PF-04950615
Hide Description This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Time Frame Single dose (Day 1: pre-dose, 24, 48, 72, 96, 120, 144, 168 hr post-dose), Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 12 12 13 11 12 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: microgram per milliliter (mcg/mL)
Single dose Number Analyzed 12 participants 12 participants 13 participants 11 participants 12 participants 12 participants
3.173
(61%)
5.074
(50%)
7.382
(45%)
2.994
(44%)
4.744
(47%)
7.726
(42%)
Multiple dose Number Analyzed 10 participants 8 participants 8 participants 10 participants 11 participants 12 participants
6.197
(36%)
8.343
(119%)
21.91
(76%)
5.874
(55%)
12.22
(29%)
23.64
(88%)
45.Secondary Outcome
Title Minimum Observed Plasma Trough Concentration (Cmin) of PF-04950615
Hide Description This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Time Frame Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, N signifies participants evaluable for this outcome measure.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 10 8 8 10 11 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg/mL
2.176
(65%)
4.041
(147%)
12.95
(94%)
2.858
(64%)
6.571
(40%)
13.47
(139%)
46.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615
Hide Description This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Time Frame Single dose (Day 1: pre-dose, 24, 48, 72, 96, 120, 144, 168 hour (hr) post-dose), Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 12 12 13 11 12 12
Median (Full Range)
Unit of Measure: day
Single dose Number Analyzed 12 participants 12 participants 13 participants 11 participants 12 participants 12 participants
4.01
(3.00 to 5.96)
4.97
(3.94 to 7.00)
5.94
(1.94 to 7.00)
5.94
(3.94 to 6.95)
5.45
(2.95 to 6.94)
6.94
(2.96 to 14.0)
Multiple dose Number Analyzed 10 participants 8 participants 8 participants 10 participants 11 participants 12 participants
3.03
(2.92 to 6.98)
2.98
(1.00 to 4.97)
2.97
(0.964 to 4.99)
2.99
(0.985 to 7.06)
2.98
(0.988 to 4.98)
4.98
(2.97 to 7.00)
47.Secondary Outcome
Title Terminal Elimination Half-Life (t1/2) of PF-04950615
Hide Description Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Time Frame Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, N signifies participants evaluable for this outcome measure.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 10 7 8 9 11 7
Mean (Standard Deviation)
Unit of Measure: day
7.716  (1.7594) 9.471  (2.2889) 10.56  (1.5934) 9.404  (2.1454) 9.570  (2.2338) 9.333  (2.7535)
48.Secondary Outcome
Title Plasma Concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Hide Description Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ =6.99 nanogram per milliliter [ng/mL]) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Time Frame Day 1, 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141
Hide Outcome Measure Data
Hide Analysis Population Description
PK concentration population included participants in FAS who have at least 1 concentration of either PF-04950615, PCSK9 or atorvastatin or its active metabolites. This outcome measure was planned to be analyzed for all the reporting groups except for Atorvastatin + Ezetimibe 10 mg.
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description:
Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug.
Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
Overall Number of Participants Analyzed 25 24 24 26 25 25 24 23
Mean (Standard Deviation)
Unit of Measure: ng/mL
Day 1 Number Analyzed 25 participants 24 participants 24 participants 26 participants 25 participants 24 participants 24 participants 23 participants
266.64  (61.5494) 261.23  (72.3625) 285.96  (75.7940) 269.19  (66.8377) 228.80  (49.9983) 215.50  (43.0086) 234.42  (77.5410) 210.22  (48.5536)
Day 5 Number Analyzed 25 participants 23 participants 23 participants 26 participants 25 participants 25 participants 24 participants 22 participants
2292.2  (676.414) 2152.6  (451.749) 1997.7  (563.722) 291.77  (65.8011) 1952.5  (527.661) 1775.4  (531.225) 1712.0  (458.574) 240.41  (63.093)
Day 8 Number Analyzed 25 participants 24 participants 24 participants 26 participants 25 participants 23 participants 23 participants 23 participants
2711.2  (614.649) 2701.9  (568.958) 2539.5  (587.196) 292.19  (62.5108) 2490.4  (573.777) 2297.7  (521.003) 2306.7  (594.409) 240.22  (53.5842)
Day 15 Number Analyzed 25 participants 24 participants 24 participants 26 participants 25 participants 23 participants 23 participants 23 participants
2539.8  (558.369) 3198.1  (897.565) 3291.9  (624.935) 303.42  (47.9418) 2590.6  (601.052) 3030.8  (715.193) 2966.7  (713.934) 224.43  (57.6903)
Day 22 Number Analyzed 20 participants 22 participants 20 participants 25 participants 16 participants 21 participants 21 participants 17 participants
3451.7  (872.597) 3297.3  (701.137) 3166.5  (663.295) 295  (71.6996) 3117.4  (582.258) 2971.6  (669.215) 2726.7  (616.409) 218.82  (41.2647)
Day 29 Number Analyzed 25 participants 23 participants 22 participants 25 participants 24 participants 23 participants 24 participants 23 participants
2844.2  (684.693) 3224.8  (868.760) 3419.8  (715.001) 275  (57.6888) 3050.0  (534.176) 3095.5  (647.481) 2955.6  (678.703) 230.09  (44.1742)
Day 36 Number Analyzed 20 participants 20 participants 21 participants 24 participants 23 participants 22 participants 23 participants 22 participants
3446.2  (825.704) 3310.7  (732.706) 3248.5  (660.213) 304.75  (48.529) 3237.0  (694.727) 3011.2  (578.469) 2761.4  (601.567) 233.09  (56.7693)
Day 43 Number Analyzed 25 participants 23 participants 22 participants 26 participants 24 participants 23 participants 24 participants 23 participants
2900.9  (653.572) 3406.3  (765.437) 3391.9  (717.922) 303.54  (81.0823) 3278.9  (693.207) 3302.5  (584.658) 3016.9  (772.615) 239.13  (43.8782)
Day 50 Number Analyzed 22 participants 22 participants 19 participants 24 participants 22 participants 22 participants 21 participants 20 participants
3394.8  (750.557) 3297.2  (654.384) 3230.9  (716.416) 293.38  (66.9138) 3148.5  (541.230) 3001.3  (696.256) 2820.3  (693.130) 237.40  (68.2421)
Day 57 Number Analyzed 25 participants 23 participants 21 participants 26 participants 23 participants 22 participants 24 participants 23 participants
2779.2  (698.727) 3204.8  (699.490) 3390.6  (1149.17) 277.69  (70.6132) 2910.6  (531.493) 3026.4  (708.490) 2791.9  (633.717) 220.13  (66.99)
Day 71 Number Analyzed 24 participants 23 participants 21 participants 26 participants 23 participants 22 participants 24 participants 23 participants
2889.6  (542.831) 3241.2  (724.363) 3280.5  (727.932) 285.81  (45.5315) 3066.8  (693.445) 3197.1  (575.162) 2887.6  (684.734) 355.17  (556.079)
Day 85 Number Analyzed 25 participants 23 participants 21 participants 26 participants 23 participants 22 participants 24 participants 23 participants
2727.0  (635.595) 3166.3  (736.216) 3198.9  (827.313) 276.31  (72.3396) 2898.7  (551.114) 2934.1  (548.311) 2787.9  (812.792) 269.61  (201.161)
Day 99 Number Analyzed 24 participants 16 participants 13 participants 25 participants 23 participants 22 participants 23 participants 23 participants
2915.1  (711.932) 3242.9  (684.758) 3259.6  (754.730) 326.08  (78.8759) 3119.2  (665.408) 3149.3  (590.228) 2918.9  (752.647) 252.13  (72.1011)
Day 106 Number Analyzed 24 participants 15 participants 12 participants 24 participants 23 participants 23 participants 21 participants 22 participants
3326.7  (611.790) 3138.9  (604.177) 2864.0  (596.757) 283.67  (58.9079) 3165.7  (786.665) 2755.7  (549.755) 2566.5  (483.133) 242.23  (59.4266)
Day 113 Number Analyzed 22 participants 15 participants 12 participants 24 participants 23 participants 23 participants 19 participants 22 participants
2727.3  (710.746) 2919.0  (511.959) 2910.3  (609.380) 267.71  (68.1498) 2908.4  (639.771) 3009.8  (685.462) 2683.9  (574.842) 222.05  (46.0574)
Day 127 Number Analyzed 24 participants 15 participants 12 participants 25 participants 23 participants 23 participants 21 participants 23 participants
1429.8  (599.406) 2148.7  (1062.32) 3030.7  (607.610) 281.40  (95.7562) 1778.9  (872.368) 2556.0  (772.015) 2769.7  (736.453) 249.87  (63.2113)
Day 141 Number Analyzed 24 participants 15 participants 13 participants 25 participants 23 participants 23 participants 21 participants 23 participants
736.63  (297.087) 1382.8  (892.457) 2851.0  (1373.69) 290.16  (84.2168) 1056.5  (545.337) 1477.0  (816.342) 2368.7  (1106.62) 20.043  (68.7012)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg QD PO PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Hide Arm/Group Description Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. Participants received Atorvastatin plus Ezetimibe 10 mg oral administration once daily for 16 week (open). Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug.
All-Cause Mortality
Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg QD PO PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg QD PO PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/25 (4.00%)   0/24 (0.00%)   0/24 (0.00%)   1/26 (3.85%)   0/22 (0.00%)   0/25 (0.00%)   1/25 (4.00%)   0/24 (0.00%)   0/23 (0.00%) 
Cardiac disorders                   
Angina pectoris * 1  0/25 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  1/26 (3.85%)  0/22 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/23 (0.00%) 
Infections and infestations                   
Cellulitis * 1  1/25 (4.00%)  0/24 (0.00%)  0/24 (0.00%)  0/26 (0.00%)  0/22 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/23 (0.00%) 
Injury, poisoning and procedural complications                   
Spinal compression fracture * 1  0/25 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/26 (0.00%)  0/22 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/24 (0.00%)  0/23 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Atorvastatin + PF-04950615 50 mg Atorvastatin + PF-04950615 100 mg Atorvastatin + PF-04950615 150 mg Atorvastatin + PF-04950615 Placebo Atorvastatin + Ezetimibe 10 mg QD PO PF-04950615 50 mg PF-04950615 100 mg PF-04950615 150 mg PF-04950615 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/25 (40.00%)   12/24 (50.00%)   12/24 (50.00%)   10/26 (38.46%)   2/22 (9.09%)   11/25 (44.00%)   11/25 (44.00%)   11/24 (45.83%)   9/23 (39.13%) 
General disorders                   
Injection site erythema * 1  2/25 (8.00%)  6/24 (25.00%)  8/24 (33.33%)  0/26 (0.00%)  0/22 (0.00%)  4/25 (16.00%)  7/25 (28.00%)  6/24 (25.00%)  1/23 (4.35%) 
Injection site haemorrhage * 1  0/25 (0.00%)  0/24 (0.00%)  1/24 (4.17%)  2/26 (7.69%)  0/22 (0.00%)  1/25 (4.00%)  1/25 (4.00%)  0/24 (0.00%)  0/23 (0.00%) 
Injection site pain * 1  0/25 (0.00%)  1/24 (4.17%)  0/24 (0.00%)  0/26 (0.00%)  0/22 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  3/24 (12.50%)  0/23 (0.00%) 
Injection site pruritus * 1  2/25 (8.00%)  4/24 (16.67%)  7/24 (29.17%)  0/26 (0.00%)  0/22 (0.00%)  4/25 (16.00%)  6/25 (24.00%)  5/24 (20.83%)  0/23 (0.00%) 
Injection site swelling * 1  0/25 (0.00%)  0/24 (0.00%)  2/24 (8.33%)  0/26 (0.00%)  0/22 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/24 (4.17%)  0/23 (0.00%) 
Infections and infestations                   
Nasopharyngitis * 1  5/25 (20.00%)  1/24 (4.17%)  1/24 (4.17%)  5/26 (19.23%)  1/22 (4.55%)  3/25 (12.00%)  4/25 (16.00%)  2/24 (8.33%)  4/23 (17.39%) 
Pharyngitis * 1  1/25 (4.00%)  0/24 (0.00%)  1/24 (4.17%)  0/26 (0.00%)  0/22 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  5/24 (20.83%)  0/23 (0.00%) 
Injury, poisoning and procedural complications                   
Contusion * 1  0/25 (0.00%)  1/24 (4.17%)  0/24 (0.00%)  0/26 (0.00%)  0/22 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/24 (0.00%)  2/23 (8.70%) 
Fall * 1  1/25 (4.00%)  1/24 (4.17%)  0/24 (0.00%)  1/26 (3.85%)  0/22 (0.00%)  0/25 (0.00%)  3/25 (12.00%)  0/24 (0.00%)  1/23 (4.35%) 
Investigations                   
Blood alkaline phosphatase increased * 1  1/25 (4.00%)  0/24 (0.00%)  0/24 (0.00%)  0/26 (0.00%)  0/22 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  2/24 (8.33%)  0/23 (0.00%) 
Musculoskeletal and connective tissue disorders                   
Back pain * 1  0/25 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  2/26 (7.69%)  0/22 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/24 (0.00%)  0/23 (0.00%) 
Myalgia * 1  1/25 (4.00%)  1/24 (4.17%)  0/24 (0.00%)  1/26 (3.85%)  0/22 (0.00%)  3/25 (12.00%)  0/25 (0.00%)  0/24 (0.00%)  1/23 (4.35%) 
Nervous system disorders                   
Dizziness * 1  0/25 (0.00%)  0/24 (0.00%)  2/24 (8.33%)  0/26 (0.00%)  0/22 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/23 (0.00%) 
Headache * 1  1/25 (4.00%)  2/24 (8.33%)  0/24 (0.00%)  0/26 (0.00%)  0/22 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  1/24 (4.17%)  2/23 (8.70%) 
Reproductive system and breast disorders                   
Ejaculation disorder * 1 [1]  0/17 (0.00%)  0/14 (0.00%)  1/12 (8.33%)  0/13 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  0/13 (0.00%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders                   
Upper respiratory tract inflammation * 1  2/25 (8.00%)  3/24 (12.50%)  0/24 (0.00%)  2/26 (7.69%)  0/22 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/23 (0.00%) 
Skin and subcutaneous tissue disorders                   
Eczema * 1  1/25 (4.00%)  0/24 (0.00%)  0/24 (0.00%)  0/26 (0.00%)  1/22 (4.55%)  3/25 (12.00%)  0/25 (0.00%)  0/24 (0.00%)  1/23 (4.35%) 
Pruritus * 1  0/25 (0.00%)  2/24 (8.33%)  0/24 (0.00%)  0/26 (0.00%)  0/22 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/24 (0.00%)  0/23 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.1
[1]
Gender specific adverse event.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02055976    
Other Study ID Numbers: B1481036
First Submitted: January 22, 2014
First Posted: February 5, 2014
Results First Submitted: September 22, 2017
Results First Posted: February 8, 2019
Last Update Posted: February 8, 2019