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A Study of Tadalafil for Duchenne Muscular Dystrophy

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: NCT01865084
Recruitment Status : Terminated (The study is being terminated for lack of efficacy)
First Posted : May 30, 2013
Results First Posted : March 1, 2017
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Muscular Dystrophy, Duchenne
Interventions Drug: Tadalafil
Drug: Placebo
Enrollment 331
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo 0.3 mg/kg Tadalafil 0.6 mg/kg Tadalafil
Hide Arm/Group Description Placebo taken orally once daily. 0.3 milligram per kilogram (mg/kg) tadalafil taken orally once daily. 0.6 mg/kg tadalafil taken orally once daily.
Period Title: Double Blind Period (DB)
Started 116 102 113
Received at Least One Dose of Study Drug 116 102 112
Completed 111 98 [1] 107
Not Completed 5 4 6
Reason Not Completed
Adverse Event             2             2             1
Protocol Violation             0             0             1
Withdrawal by Parent/Guardian             2             2             4
Withdrawal by Subject             1             0             0
[1]
One participant stopped therapy during the DB period but remained in the study for follow-up.
Period Title: Open Label Extension (OLE) Period
Started 0 [1] 150 [1] 165 [1]
Completed 0 139 158
Not Completed 0 11 7
Reason Not Completed
Adverse Event             0             0             1
Lack of Efficacy             0             0             2
Lost to Follow-up             0             1             0
Withdrawal by Parent/Guardian             0             8             2
Withdrawal by Subject             0             2             2
[1]
Participants who were on Placebo during the double blind period were assigned tadalafil during OLE.
Arm/Group Title Placebo 0.3 mg/kg Tadalafil 0.6 mg/kg Tadalafil Total
Hide Arm/Group Description Placebo taken orally once daily. 0.3 milligram per kilogram (mg/kg) tadalafil taken orally once daily. 0.6 mg/kg tadalafil taken orally once daily. Total of all reporting groups
Overall Number of Baseline Participants 116 102 113 331
Hide Baseline Analysis Population Description
All participants who were randomized to study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 116 participants 102 participants 113 participants 331 participants
9.4  (1.76) 9.9  (2.26) 9.5  (1.71) 9.6  (1.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 102 participants 113 participants 331 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
116
 100.0%
102
 100.0%
113
 100.0%
331
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 102 participants 113 participants 331 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
2
   1.8%
2
   0.6%
Asian
15
  12.9%
16
  15.7%
20
  17.7%
51
  15.4%
Native Hawaiian or Other Pacific Islander
3
   2.6%
1
   1.0%
3
   2.7%
7
   2.1%
Black or African American
0
   0.0%
0
   0.0%
1
   0.9%
1
   0.3%
White
96
  82.8%
82
  80.4%
84
  74.3%
262
  79.2%
More than one race
2
   1.7%
3
   2.9%
2
   1.8%
7
   2.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   0.9%
1
   0.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 116 participants 102 participants 113 participants 331 participants
Argentina
7
   6.0%
4
   3.9%
6
   5.3%
17
   5.1%
Russian Federation
4
   3.4%
4
   3.9%
4
   3.5%
12
   3.6%
United States
39
  33.6%
34
  33.3%
34
  30.1%
107
  32.3%
Japan
6
   5.2%
5
   4.9%
6
   5.3%
17
   5.1%
Spain
9
   7.8%
7
   6.9%
12
  10.6%
28
   8.5%
Canada
8
   6.9%
7
   6.9%
8
   7.1%
23
   6.9%
Netherlands
2
   1.7%
1
   1.0%
3
   2.7%
6
   1.8%
Turkey
5
   4.3%
7
   6.9%
8
   7.1%
20
   6.0%
Belgium
8
   6.9%
5
   4.9%
4
   3.5%
17
   5.1%
Taiwan
6
   5.2%
4
   3.9%
8
   7.1%
18
   5.4%
Korea, Republic of
3
   2.6%
4
   3.9%
5
   4.4%
12
   3.6%
Italy
8
   6.9%
8
   7.8%
8
   7.1%
24
   7.3%
France
3
   2.6%
2
   2.0%
2
   1.8%
7
   2.1%
Germany
8
   6.9%
10
   9.8%
5
   4.4%
23
   6.9%
1.Primary Outcome
Title Change From Baseline in Six Minute Walk Distance (6MWD) in Meters
Hide Description 6MWD measured the distance in meters a participant was able to walk in 6 minutes. The study used 6MWD procedure modified specifically for use in boys with Duchenne muscular dystrophy (DMD), including standardized verbal encouragement at specific intervals to maintain attention to the test, and use of a "safety chaser" to walk behind the participant during testing (McDonald et al., 2010a). The LS mean (LSM) change from baseline, standard error was derived using mixed model repeated measures (MMRM) methodology with factors for pooled country, treatment, visit, treatment-by-visit interaction and baseline 6MWD as a covariate.
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug who had a baseline and at least one post-baseline measurement.
Arm/Group Title Placebo 0.3 mg/kg Tadalafil 0.6 mg/kg Tadalafil
Hide Arm/Group Description:
Placebo taken orally once daily.
0.3 mg/kg tadalafil taken orally once daily.
0.6 mg/kg taken tadalafil orally once daily.
Overall Number of Participants Analyzed 113 101 111
Least Squares Mean (Standard Error)
Unit of Measure: Meters
-50.99  (9.316) -64.71  (9.809) -59.08  (9.397)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 0.3 mg/kg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.307
Comments The p-value is based on the treatment difference LS Mean changes from baseline between tadalafil and placebo.
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 0.6 mg/kg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.538
Comments The p-value is based on the treatment difference LS Mean changes from baseline between tadalafil and placebo.
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in the North Star Ambulatory Assessment (NSAA) Global Score
Hide Description The NSAA is a functional scale specifically designed for ambulant boys with DMD that can provide additional information on motor functions important in maintaining normal ambulation and other activities important to everyday life. The NSAA is a 17-item evaluation of standing, ability to transition from lying to sitting, sitting to standing, and other mobility assessments. Each of the 17 items is evaluated on an ordinal scale of 0, 1, or 2, with higher scores reflecting better performance on the assessment, for a total maximum score of 34. This score was transformed to a 0 to 100 scale for the key analysis (referred to as linearized), with higher transformed scores reflecting better performance.The LS mean (LSM) change from baseline standard error was derived using mixed model repeated measures methodology (MMRM) with factors for pooled country, treatment, visit, treatment-by-visit interaction and Day 1 value as baseline covariate.
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug who had a baseline and at least one post-baseline measurement.
Arm/Group Title Placebo 0.3 mg/kg Tadalafil 0.6 mg/kg Tadalafil
Hide Arm/Group Description:
Placebo taken orally once daily.
0.3 mg/kg tadalafil taken orally once daily.
0.6 mg/kg tadalafil taken orally once daily.
Overall Number of Participants Analyzed 116 102 112
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-8.80  (1.104) -9.31  (1.181) -8.96  (1.115)
3.Secondary Outcome
Title Change From Baseline in Timed Function Tests in Seconds
Hide Description Timed function tests included time it took to rise from floor, walk 10 meters, ascend 4 stairs, and descend 4 stairs.The lower the time in seconds taken, the better the performance. The LS mean change from baseline, standard error, was derived using mixed model repeated measures methodology (MMRM) with factors for pooled country, treatment, visit, treatment-by-visit interaction and Day 1 value as baseline covariate.
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug who had a baseline and at least one post-baseline measurement.
Arm/Group Title Placebo 0.3 mg/kg Tadalafil 0.6 mg/kg Tadalafil
Hide Arm/Group Description:
Placebo taken orally once daily.
0.3 mg/kg tadalafil taken orally once daily.
0.6 mg/kg tadalafil taken orally once daily.
Overall Number of Participants Analyzed 116 96 110
Least Squares Mean (Standard Error)
Unit of Measure: Seconds
Rise from the Floor(n=92,75,89) 4.16  (1.120) 3.60  (1.223) 4.81  (1.156)
10 Meter Walk/Run(n=105,90,100) 1.11  (0.204) 0.95  (0.226) 1.12  (0.217)
Stair Climb (n=116,96,110) 3.96  (1.041) 4.10  (1.154) 5.82  (1.072)
Stair Descend(n=115,95,110) 3.19  (0.827) 2.07  (0.915) 3.27  (0.853)
4.Secondary Outcome
Title Time to Persistent 10% Worsening in 6MWD
Hide Description Time on study until the 6MWD becomes 10% less than the baseline 6MWD and continues at that level or lower until the end of study.
Time Frame Baseline through Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug who had complete evaluable data. Complete evaluable data was defined as having baseline measurement, complete dates at evaluable visits and a post-baseline measurement at each evaluable visit. Censored participants: placebo=71, 0.3 mg/kg=63, 0.6 mg/kg=61.
Arm/Group Title Placebo 0.3 mg/kg Tadalafil 0.6 mg/kg Tadalafil
Hide Arm/Group Description:
Placebo taken orally once daily.
0.3 mg/kg tadalafil taken orally once daily.
0.6 mg/kg tadalafil taken orally once daily.
Overall Number of Participants Analyzed 115 101 111
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
These statistics were not estimable due to large number of participants who were censored.
5.Secondary Outcome
Title Time to Persistent 10% Worsening in Timed Function Tests (TFT)
Hide Description

Time on study until the TFT becomes 10% worse than the baseline TFT and continues at that level or lower until the end of study. The time to persistent 10% worsening is the observed time after baseline until the first observed timepoint where their time used for the TFTs is >110% of the baseline time and all the time values observed afterward are also >110% of baseline. If the participant discontinues prior to experiencing persistent worsening, this outcome for the participant is censored at the date of discontinuation of the double-blind period.

Only participants with complete evaluable data were analyzed. Complete evaluable data was defined as having baseline measurement, complete dates at evaluable visits and a post-baseline measurement at each evaluable visit.
Time Frame Baseline through Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug who had complete evaluable data.Censored participants:Rise from Floor;placebo(pl)=40,0.3 mg/kg=39,0.6 mg/kg=43;Stair Climb;pl=55,0.3 mg/kg=45,0.6 mg/kg=52;10 Meter Walk/Run pl=61,0.3 mg/kg=65,0.6 mg/kg=58,Stair Descend;pl=63,0.3 mg/kg=60,0.6 mg/kg=59.
Arm/Group Title Placebo 0.3 mg/kg Tadalafil 0.6 mg/kg Tadalafil
Hide Arm/Group Description:
Placebo taken orally once daily.
0.3 mg/kg tadalafil taken orally once daily.
0.6 mg/kg tadalafil taken orally once daily.
Overall Number of Participants Analyzed 116 102 113
Median (95% Confidence Interval)
Unit of Measure: Days
Rise from the Floor (n=81,67,77)
253.0 [1] 
(170.0 to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Stair Climb (n=112,91,107)
255.0 [1] 
(252.0 to NA)
259.0 [1] 
(176.0 to NA)
253.0 [1] 
(185.0 to NA)
10 Meter Walk/Run (n=98,83,91)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Stair Descend (n=110,91,108)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
These statistics were not estimable due to large number of participants who were censored.
6.Secondary Outcome
Title Change From Baseline in Pediatric Outcomes Data Collection Instrument (PODCI) Scores
Hide Description PODCI includes a Global Functioning Scale and 5 core scales:Upper Extremity and Physical Function,Transfer/Basic Mobility, Sports/Physical Functioning, Pain/Comfort,and Happiness.The Global Functioning Scale is the mean of the mean scores from 4 of the 5 core scales (all except the happiness core scale).The following PODCI scores were prespecified in the protocol for analysis: Global Functioning, Upper Extremity and Physical Function,Transfer/Basic Mobility, and Sports/Physical Functioning. The Global Functioning Scale and each of the core scales were standardized so that a score of "0" represents a poor outcome/worse health, while "100" is the best possible outcome/best health (i.e., complete range of each score is 0 to 100, with higher scores representing better functioning). The LS mean (LSM) change from baseline,standard error was derived using MMRM with factors for pooled country, treatment, visit, treatment-by-visit interaction and baseline PODC scale as covariate.
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug who had a baseline and at least one post-baseline measurement. The reason the number of participants analyzed is significantly less than the total number of randomized participants is because PODCI was administered only in English.
Arm/Group Title Placebo 0.3 mg/kg Tadalafil 0.6 mg/kg Tadalafil
Hide Arm/Group Description:
Placebo taken orally once daily.
0.3 mg/kg tadalafil taken orally once daily.
0.6 mg/kg tadalafil taken orally once daily.
Overall Number of Participants Analyzed 41 35 34
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Global Functioning Scale (n=41,34,34) -8.81  (1.770) -7.36  (1.929) -7.34  (1.888)
Upper Extremity & Physical Function -5.47  (1.901) -3.73  (2.060) -2.47  (2.042)
Transfer/Basic Mobility Core Scale -14.26  (3.037) -12.50  (3.260) -12.78  (3.279)
Sports/Physical Functioning Core Scale -12.47  (2.362) -11.98  (2.552) -7.88  (2.537)
7.Secondary Outcome
Title Pharmacokinetics (PK): Apparent Clearance (CL/F) of Tadalafil
Hide Description The data reported are population estimate and inter-patient variability.
Time Frame Weeks 4, 12, 24 and 36: -1 Hour up to 24 Hours Postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable PK data.
Arm/Group Title 0.3 mg/kg Tadalafil and 0.6 mg/kg Tadalafil
Hide Arm/Group Description:

0.3 mg/kg tadalafil taken orally once daily.

0.6 mg/kg tadalafil taken orally once daily.
Overall Number of Participants Analyzed 210
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liter per hour (L/hr)
1.79
(29.6%)
Time Frame [Not Specified]
Adverse Event Reporting Description

All randomized participants who received at least one dose of study drug for Placebo - DB, 0.3 mg/kg Tadalafil -DB and 0.6 mg/kg Tadalafil - DB arms during the DB period.

All randomized participants who received at least one dose of study drug for 0.3 mg/kg Tadalafil - OLE and 0.6 mg/kg Tadalafil - OLE arms during the OLE period.
 
Arm/Group Title Placebo - DB 0.3 mg/kg Tadalafil -DB 0.6 mg/kg Tadalafil - DB 0.3 mg/kg Tadalafil - OLE 0.6 mg/kg Tadalafil - OLE
Hide Arm/Group Description Placebo taken orally once daily. 0.3 milligram per kilogram (mg/kg) tadalafil taken orally once daily. 0.6 mg/kg tadalafil taken orally once daily. 0.3 mg/kg tadalafil taken orally once daily. 0.6 mg/kg tadalafil taken orally once daily.
All-Cause Mortality
Placebo - DB 0.3 mg/kg Tadalafil -DB 0.6 mg/kg Tadalafil - DB 0.3 mg/kg Tadalafil - OLE 0.6 mg/kg Tadalafil - OLE
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo - DB 0.3 mg/kg Tadalafil -DB 0.6 mg/kg Tadalafil - DB 0.3 mg/kg Tadalafil - OLE 0.6 mg/kg Tadalafil - OLE
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/116 (4.31%)      4/102 (3.92%)      6/112 (5.36%)      6/150 (4.00%)      9/165 (5.45%)    
Cardiac disorders           
Myocarditis * 1  0/116 (0.00%)  0 1/102 (0.98%)  1 0/112 (0.00%)  0 0/150 (0.00%)  0 0/165 (0.00%)  0
Gastrointestinal disorders           
Vomiting * 1  0/116 (0.00%)  0 0/102 (0.00%)  0 0/112 (0.00%)  0 0/150 (0.00%)  0 1/165 (0.61%)  1
General disorders           
Abasia * 1  1/116 (0.86%)  1 0/102 (0.00%)  0 0/112 (0.00%)  0 1/150 (0.67%)  1 0/165 (0.00%)  0
Infections and infestations           
Appendicitis * 1  0/116 (0.00%)  0 0/102 (0.00%)  0 0/112 (0.00%)  0 0/150 (0.00%)  0 1/165 (0.61%)  1
Bronchitis * 1  1/116 (0.86%)  1 0/102 (0.00%)  0 0/112 (0.00%)  0 0/150 (0.00%)  0 0/165 (0.00%)  0
Gastroenteritis * 1  0/116 (0.00%)  0 0/102 (0.00%)  0 0/112 (0.00%)  0 0/150 (0.00%)  0 1/165 (0.61%)  1
Gastroenteritis viral * 1  0/116 (0.00%)  0 0/102 (0.00%)  0 0/112 (0.00%)  0 0/150 (0.00%)  0 1/165 (0.61%)  1
Gastrointestinal infection * 1  0/116 (0.00%)  0 1/102 (0.98%)  1 0/112 (0.00%)  0 0/150 (0.00%)  0 0/165 (0.00%)  0
Influenza * 1  0/116 (0.00%)  0 0/102 (0.00%)  0 0/112 (0.00%)  0 0/150 (0.00%)  0 1/165 (0.61%)  1
Pharyngotonsillitis * 1  0/116 (0.00%)  0 0/102 (0.00%)  0 1/112 (0.89%)  1 0/150 (0.00%)  0 0/165 (0.00%)  0
Pneumonia * 1  0/116 (0.00%)  0 1/102 (0.98%)  1 0/112 (0.00%)  0 0/150 (0.00%)  0 1/165 (0.61%)  1
Pneumonia adenoviral * 1  0/116 (0.00%)  0 0/102 (0.00%)  0 1/112 (0.89%)  1 0/150 (0.00%)  0 0/165 (0.00%)  0
Varicella * 1  0/116 (0.00%)  0 0/102 (0.00%)  0 1/112 (0.89%)  1 0/150 (0.00%)  0 0/165 (0.00%)  0
Injury, poisoning and procedural complications           
Ankle fracture * 1  0/116 (0.00%)  0 0/102 (0.00%)  0 0/112 (0.00%)  0 1/150 (0.67%)  1 0/165 (0.00%)  0
Fall * 1  1/116 (0.86%)  1 0/102 (0.00%)  0 2/112 (1.79%)  2 1/150 (0.67%)  1 1/165 (0.61%)  1
Femoral neck fracture * 1  1/116 (0.86%)  1 0/102 (0.00%)  0 0/112 (0.00%)  0 0/150 (0.00%)  0 0/165 (0.00%)  0
Femur fracture * 1  0/116 (0.00%)  0 0/102 (0.00%)  0 2/112 (1.79%)  2 1/150 (0.67%)  1 1/165 (0.61%)  1
Lower limb fracture * 1  1/116 (0.86%)  1 0/102 (0.00%)  0 0/112 (0.00%)  0 0/150 (0.00%)  0 0/165 (0.00%)  0
Spinal fracture * 1  0/116 (0.00%)  0 0/102 (0.00%)  0 0/112 (0.00%)  0 0/150 (0.00%)  0 1/165 (0.61%)  1
Metabolism and nutrition disorders           
Decreased appetite * 1  0/116 (0.00%)  0 0/102 (0.00%)  0 0/112 (0.00%)  0 1/150 (0.67%)  1 0/165 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Muscle contracture * 1  0/116 (0.00%)  0 1/102 (0.98%)  1 0/112 (0.00%)  0 0/150 (0.00%)  0 0/165 (0.00%)  0
Tendinous contracture * 1  1/116 (0.86%)  1 0/102 (0.00%)  0 1/112 (0.89%)  1 1/150 (0.67%)  1 0/165 (0.00%)  0
Tendon disorder * 1  0/116 (0.00%)  0 0/102 (0.00%)  0 0/112 (0.00%)  0 0/150 (0.00%)  0 1/165 (0.61%)  1
Nervous system disorders           
Extrapyramidal disorder * 1  0/116 (0.00%)  0 0/102 (0.00%)  0 0/112 (0.00%)  0 1/150 (0.67%)  1 0/165 (0.00%)  0
Psychiatric disorders           
Self injurious behaviour * 1  0/116 (0.00%)  0 0/102 (0.00%)  0 0/112 (0.00%)  0 0/150 (0.00%)  0 1/165 (0.61%)  1
Suicidal ideation * 1  0/116 (0.00%)  0 0/102 (0.00%)  0 0/112 (0.00%)  0 0/150 (0.00%)  0 1/165 (0.61%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo - DB 0.3 mg/kg Tadalafil -DB 0.6 mg/kg Tadalafil - DB 0.3 mg/kg Tadalafil - OLE 0.6 mg/kg Tadalafil - OLE
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   83/116 (71.55%)      82/102 (80.39%)      92/112 (82.14%)      68/150 (45.33%)      84/165 (50.91%)    
Gastrointestinal disorders           
Abdominal pain * 1  6/116 (5.17%)  7 4/102 (3.92%)  4 9/112 (8.04%)  9 2/150 (1.33%)  2 3/165 (1.82%)  3
Abdominal pain upper * 1  7/116 (6.03%)  7 5/102 (4.90%)  6 8/112 (7.14%)  8 4/150 (2.67%)  5 2/165 (1.21%)  2
Diarrhoea * 1  10/116 (8.62%)  10 6/102 (5.88%)  9 10/112 (8.93%)  19 9/150 (6.00%)  13 7/165 (4.24%)  7
Nausea * 1  2/116 (1.72%)  2 7/102 (6.86%)  8 3/112 (2.68%)  3 1/150 (0.67%)  1 1/165 (0.61%)  1
Vomiting * 1  14/116 (12.07%)  20 6/102 (5.88%)  6 17/112 (15.18%)  25 9/150 (6.00%)  12 10/165 (6.06%)  11
General disorders           
Abasia * 1  6/116 (5.17%)  6 14/102 (13.73%)  14 9/112 (8.04%)  9 12/150 (8.00%)  12 16/165 (9.70%)  16
Pyrexia * 1  4/116 (3.45%)  4 11/102 (10.78%)  11 9/112 (8.04%)  10 7/150 (4.67%)  8 6/165 (3.64%)  6
Infections and infestations           
Gastroenteritis * 1  6/116 (5.17%)  6 4/102 (3.92%)  4 3/112 (2.68%)  3 3/150 (2.00%)  3 2/165 (1.21%)  2
Influenza * 1  9/116 (7.76%)  9 8/102 (7.84%)  9 5/112 (4.46%)  5 3/150 (2.00%)  3 2/165 (1.21%)  2
Nasopharyngitis * 1  16/116 (13.79%)  26 8/102 (7.84%)  10 18/112 (16.07%)  24 8/150 (5.33%)  10 12/165 (7.27%)  12
Sinusitis * 1  6/116 (5.17%)  11 4/102 (3.92%)  5 3/112 (2.68%)  3 1/150 (0.67%)  1 0/165 (0.00%)  0
Upper respiratory tract infection * 1  10/116 (8.62%)  18 10/102 (9.80%)  21 12/112 (10.71%)  16 6/150 (4.00%)  15 8/165 (4.85%)  10
Injury, poisoning and procedural complications           
Fall * 1  24/116 (20.69%)  41 18/102 (17.65%)  30 22/112 (19.64%)  41 16/150 (10.67%)  22 15/165 (9.09%)  18
Musculoskeletal and connective tissue disorders           
Back pain * 1  9/116 (7.76%)  15 11/102 (10.78%)  12 7/112 (6.25%)  7 7/150 (4.67%)  7 9/165 (5.45%)  9
Muscle spasms * 1  7/116 (6.03%)  9 3/102 (2.94%)  3 3/112 (2.68%)  4 0/150 (0.00%)  0 2/165 (1.21%)  2
Pain in extremity * 1  8/116 (6.90%)  14 6/102 (5.88%)  6 10/112 (8.93%)  11 2/150 (1.33%)  2 4/165 (2.42%)  4
Nervous system disorders           
Headache * 1  36/116 (31.03%)  92 40/102 (39.22%)  57 43/112 (38.39%)  68 8/150 (5.33%)  12 14/165 (8.48%)  19
Reproductive system and breast disorders           
Erection increased * 1  3/116 (2.59%)  3 10/102 (9.80%)  11 17/112 (15.18%)  18 2/150 (1.33%)  2 4/165 (2.42%)  4
Spontaneous penile erection * 1  4/116 (3.45%)  6 13/102 (12.75%)  13 13/112 (11.61%)  14 3/150 (2.00%)  3 4/165 (2.42%)  4
Respiratory, thoracic and mediastinal disorders           
Cough * 1  10/116 (8.62%)  11 4/102 (3.92%)  4 5/112 (4.46%)  5 4/150 (2.67%)  5 5/165 (3.03%)  5
Epistaxis * 1  5/116 (4.31%)  11 10/102 (9.80%)  15 6/112 (5.36%)  8 4/150 (2.67%)  6 3/165 (1.82%)  5
Skin and subcutaneous tissue disorders           
Rash * 1  7/116 (6.03%)  7 3/102 (2.94%)  3 5/112 (4.46%)  5 3/150 (2.00%)  3 1/165 (0.61%)  1
Vascular disorders           
Flushing * 1  3/116 (2.59%)  3 8/102 (7.84%)  8 8/112 (7.14%)  9 2/150 (1.33%)  2 2/165 (1.21%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.1
The Sponsor concluded that the efficacy results do not provide sufficient justification for continuance of the open-label extension (OLE) period of the study, where all participants were receiving daily treatment with tadalafil.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01865084    
Other Study ID Numbers: 15122
H6D-MC-LVJJ ( Other Identifier: Eli Lilly and Company )
First Submitted: May 24, 2013
First Posted: May 30, 2013
Results First Submitted: September 30, 2016
Results First Posted: March 1, 2017
Last Update Posted: October 9, 2019