Dose Ranging Study Of Bococizumab (PF-04950615; RN316) In Hypercholesterolemic Japanese Subjects
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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:
Pfizer
Information provided by (Responsible Party):
Pfizer
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Study Type | Interventional |
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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 |
Participant Flow
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 |
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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 |
Baseline Characteristics
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 | |
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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 | |
Baseline Analysis Population Description |
Safety analysis set included all randomized and non-randomized participants who were administered at least 1 dose of study treatment.
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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 |
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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%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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
Name/Title: | Pfizer ClinicalTrials.gov Call Center |
Organization: | Pfizer, Inc. |
Phone: | 1-800-718-1021 |
EMail: | ClinicalTrials.gov_Inquiries@pfizer.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |