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Effect of Eleclazine (GS-6615) on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy (LIBERTY-HCM)

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ClinicalTrials.gov Identifier: NCT02291237
Recruitment Status : Terminated
First Posted : November 14, 2014
Results First Posted : March 22, 2018
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hypertrophic Cardiomyopathy
Interventions Drug: Eleclazine
Drug: Placebo
Enrollment 172
Recruitment Details Participants were enrolled at study sites in Asia, Australia, Europe and North America. The first participant was screened on 05 February 2015. The last study visit occurred on 22 February 2017.
Pre-assignment Details 264 participants were screened.
Arm/Group Title Eleclazine 30/3/6 mg Placebo
Hide Arm/Group Description Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24 Placebo to match eleclazine administered orally for at least 24 weeks
Period Title: Overall Study
Started 86 86
Completed 0 0
Not Completed 86 86
Reason Not Completed
Study Terminated by Sponsor             72             67
Adverse Event             1             3
Investigator's Discretion             0             3
Withdrew Consent             11             11
Lost to Follow-up             0             2
Subject Required Prohibited Medication             2             0
Arm/Group Title Eleclazine 30/3/6 mg Placebo Total
Hide Arm/Group Description Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24 Placebo to match eleclazine administered orally for up to at least 24 weeks Total of all reporting groups
Overall Number of Baseline Participants 86 86 172
Hide Baseline Analysis Population Description
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 86 participants 86 participants 172 participants
46  (11.7) 48  (10.3) 47  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 86 participants 172 participants
Female
37
  43.0%
36
  41.9%
73
  42.4%
Male
49
  57.0%
50
  58.1%
99
  57.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 86 participants 172 participants
White
74
  86.0%
73
  84.9%
147
  85.5%
Black or African American
7
   8.1%
3
   3.5%
10
   5.8%
Asian
2
   2.3%
7
   8.1%
9
   5.2%
Other
2
   2.3%
1
   1.2%
3
   1.7%
Not Permitted
0
   0.0%
2
   2.3%
2
   1.2%
American Indian or Alaska Native
1
   1.2%
0
   0.0%
1
   0.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 86 participants 172 participants
Hispanic Or Latino
11
  12.8%
9
  10.5%
20
  11.6%
Not Hispanic Or Latino
75
  87.2%
75
  87.2%
150
  87.2%
Not Permitted
0
   0.0%
2
   2.3%
2
   1.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 86 participants 86 participants 172 participants
55 54 109
Australia Number Analyzed 86 participants 86 participants 172 participants
1 1 2
France Number Analyzed 86 participants 86 participants 172 participants
3 5 8
Germany Number Analyzed 86 participants 86 participants 172 participants
2 2 4
Israel Number Analyzed 86 participants 86 participants 172 participants
8 6 14
Italy Number Analyzed 86 participants 86 participants 172 participants
12 13 25
Netherlands Number Analyzed 86 participants 86 participants 172 participants
2 5 7
United Kingdom Number Analyzed 86 participants 86 participants 172 participants
3 0 3
Peak Oxygen Intake (VO2)   [1] 
Mean (Standard Deviation)
Unit of measure:  mL/kg/min
Number Analyzed 86 participants 85 participants 171 participants
19.06  (4.853) 19.88  (4.645) 19.47  (4.755)
[1]
Measure Analysis Population Description: Only 85 participants with available data from the placebo arm in safety analysis set were analyzed at baseline.
1.Primary Outcome
Title Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 24
Hide Description [Not Specified]
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Eleclazine 30/3/6 mg Placebo
Hide Arm/Group Description:
Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
Placebo to match eleclazine administered orally for at least 24 weeks
Overall Number of Participants Analyzed 73 68
Mean (Standard Deviation)
Unit of Measure: mL/kg/min
0.15  (4.312) 0.48  (4.143)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eleclazine 30/3/6 mg, Placebo
Comments The analysis evaluated the change in Peak VO2 from baseline to Week 24 for the eleclazine group compared with that of the placebo group using analysis of covariance (ANCOVA) including terms for baseline Peak VO2, sex, and age (continuous).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.416
Comments [Not Specified]
Method ANCOVA
Comments P-value and Least Squares (LS) Means are from model with terms for sex, age (continuous), and treatment group and baseline peak VO2 as the covariate.
Method of Estimation Estimation Parameter LS Mean Difference(Eleclazine - Placebo)
Estimated Value -0.55
Confidence Interval (2-Sided) 95%
-1.87 to 0.78
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 12
Hide Description [Not Specified]
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Eleclazine 30/3/6 mg Placebo
Hide Arm/Group Description:
Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
Placebo to match eleclazine administered orally for at least 24 weeks
Overall Number of Participants Analyzed 83 78
Mean (Standard Deviation)
Unit of Measure: mL/kg/min
0.28  (4.028) 0.57  (4.314)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eleclazine 30/3/6 mg, Placebo
Comments The analysis evaluated the change in Peak VO2 from baseline to Week 12 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline Peak VO2, sex, and age (continuous).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.517
Comments P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline peak VO2 as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference(Eleclazine − Placebo)
Estimated Value -0.42
Confidence Interval (2-Sided) 95%
-1.68 to 0.85
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 24
Hide Description The MLHFQ is a 21-item quality of life (QoL) questionnaire that measures the effects of symptoms, functional limitations, and psychological distress on an individual. Each item is measured on a 6-point Likert scale (0 to 5) and is scored by summing the responses to all 21 questions. Scores range from 0 to 105, with lower scores indicating a better quality of life.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Eleclazine 30/3/6 mg Placebo
Hide Arm/Group Description:
Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
Placebo to match eleclazine administered orally for at least 24 weeks
Overall Number of Participants Analyzed 86 86
Mean (Standard Deviation)
Unit of Measure: Score
Baseline Number Analyzed 86 participants 86 participants
40.22  (25.544) 38.80  (23.177)
Change from Baseline at Week 24 Number Analyzed 74 participants 73 participants
-4.05  (15.164) -5.57  (14.345)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eleclazine 30/3/6 mg, Placebo
Comments The analysis evaluated the change in MLHFQ from baseline to Week 24 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.513
Comments [Not Specified]
Method ANCOVA
Comments P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.
Method of Estimation Estimation Parameter LS Mean Difference(Eleclazine - Placebo)
Estimated Value 1.54
Confidence Interval (2-Sided) 95%
-3.11 to 6.19
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 12
Hide Description The MLHFQ is a 21-item quality of life (QoL) questionnaire that measures the effects of symptoms, functional limitations, and psychological distress on an individual. Each item is measured on a 6-point Likert scale (0 to 5) and is scored by summing the responses to all 21 questions. Scores range from 0 to 105, with lower scores indicating a better quality of life.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Eleclazine 30/3/6 mg Placebo
Hide Arm/Group Description:
Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
Placebo to match eleclazine administered orally for at least 24 weeks
Overall Number of Participants Analyzed 86 86
Mean (Standard Deviation)
Unit of Measure: Score
Baseline Number Analyzed 86 participants 86 participants
40.22  (25.544) 38.80  (23.177)
Change at Week 12 Number Analyzed 85 participants 80 participants
-3.84  (15.654) -3.40  (13.780)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eleclazine 30/3/6 mg, Placebo
Comments The analysis evaluated the change in MLHFQ from baseline to Week 12 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.964
Comments [Not Specified]
Method ANCOVA
Comments P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.
Method of Estimation Estimation Parameter LS Mean Difference(Eleclazine − Placebo)
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
-4.36 to 4.56
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Treadmill Exercise Time From Baseline to Week 24
Hide Description Treadmill exercise time is the time to peak exercise.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Eleclazine 30/3/6 mg Placebo
Hide Arm/Group Description:
Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
Placebo to match eleclazine administered orally for at least 24 weeks
Overall Number of Participants Analyzed 86 86
Mean (Standard Deviation)
Unit of Measure: min
Baseline Number Analyzed 86 participants 84 participants
12.88  (4.641) 13.60  (4.317)
Change from Baseline at Week 24 Number Analyzed 73 participants 68 participants
0.27  (3.954) 0.24  (3.208)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eleclazine 30/3/6 mg, Placebo
Comments The analysis evaluated the change in treadmill exercise time from baseline to Week 24 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.944
Comments [Not Specified]
Method ANCOVA
Comments P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.
Method of Estimation Estimation Parameter LS Mean Difference(Eleclazine - Placebo)
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-1.18 to 1.10
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change in Treadmill Exercise Time From Baseline to Week 12
Hide Description Treadmill exercise time is the time to peak exercise.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Eleclazine 30/3/6 mg Placebo
Hide Arm/Group Description:
Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
Placebo to match eleclazine administered orally for at least 24 weeks
Overall Number of Participants Analyzed 86 86
Mean (Standard Deviation)
Unit of Measure: min
Baseline Number Analyzed 86 participants 84 participants
12.88  (4.641) 13.60  (4.317)
Change from Baseline at Week 12 Number Analyzed 83 participants 77 participants
0.48  (3.295) 0.38  (3.030)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eleclazine 30/3/6 mg, Placebo
Comments The analysis evaluated the change in treadmill exercise time from baseline to Week 12 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.993
Comments [Not Specified]
Method ANCOVA
Comments P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.
Method of Estimation Estimation Parameter LS Mean Difference(Eleclazine - Placebo)
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-0.96 to 0.97
Estimation Comments [Not Specified]
Time Frame Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Adverse Event Reporting Description Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
 
Arm/Group Title Eleclazine 30/3/6 mg Placebo
Hide Arm/Group Description Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24 Placebo to match eleclazine administered orally for at least 24 weeks
All-Cause Mortality
Eleclazine 30/3/6 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/86 (0.00%)   0/86 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Eleclazine 30/3/6 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   14/86 (16.28%)   16/86 (18.60%) 
Cardiac disorders     
ATRIAL FIBRILLATION  1  2/86 (2.33%)  1/86 (1.16%) 
ATRIAL FLUTTER  1  1/86 (1.16%)  0/86 (0.00%) 
CARDIAC FAILURE  1  1/86 (1.16%)  0/86 (0.00%) 
CARDIAC FAILURE ACUTE  1  1/86 (1.16%)  0/86 (0.00%) 
CARDIAC FAILURE CONGESTIVE  1  2/86 (2.33%)  0/86 (0.00%) 
SINUS BRADYCARDIA  1  0/86 (0.00%)  1/86 (1.16%) 
VENTRICULAR TACHYCARDIA  1  0/86 (0.00%)  3/86 (3.49%) 
Congenital, familial and genetic disorders     
HYPERTROPHIC CARDIOMYOPATHY  1  0/86 (0.00%)  1/86 (1.16%) 
General disorders     
CHEST PAIN  1  2/86 (2.33%)  2/86 (2.33%) 
NON-CARDIAC CHEST PAIN  1  1/86 (1.16%)  0/86 (0.00%) 
Hepatobiliary disorders     
CHOLECYSTITIS  1  1/86 (1.16%)  0/86 (0.00%) 
Immune system disorders     
DRUG HYPERSENSITIVITY  1  1/86 (1.16%)  0/86 (0.00%) 
Infections and infestations     
CELLULITIS  1  0/86 (0.00%)  1/86 (1.16%) 
CLOSTRIDIUM DIFFICILE INFECTION  1  1/86 (1.16%)  0/86 (0.00%) 
DEVICE RELATED INFECTION  1  2/86 (2.33%)  0/86 (0.00%) 
DIVERTICULITIS  1  0/86 (0.00%)  1/86 (1.16%) 
ENDOCARDITIS  1  1/86 (1.16%)  0/86 (0.00%) 
ESCHERICHIA URINARY TRACT INFECTION  1  1/86 (1.16%)  0/86 (0.00%) 
GASTROENTERITIS  1  1/86 (1.16%)  0/86 (0.00%) 
INFLUENZA  1  1/86 (1.16%)  0/86 (0.00%) 
PNEUMONIA  1  1/86 (1.16%)  0/86 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  0/86 (0.00%)  1/86 (1.16%) 
Injury, poisoning and procedural complications     
CLAVICLE FRACTURE  1  1/86 (1.16%)  0/86 (0.00%) 
FOOT FRACTURE  1  0/86 (0.00%)  1/86 (1.16%) 
POST PROCEDURAL COMPLICATION  1  1/86 (1.16%)  0/86 (0.00%) 
SCAPULA FRACTURE  1  1/86 (1.16%)  0/86 (0.00%) 
Investigations     
CARDIAC INDEX DECREASED  1  1/86 (1.16%)  0/86 (0.00%) 
Metabolism and nutrition disorders     
HYPOKALAEMIA  1  1/86 (1.16%)  0/86 (0.00%) 
Musculoskeletal and connective tissue disorders     
BACK PAIN  1  1/86 (1.16%)  0/86 (0.00%) 
INTERVERTEBRAL DISC PROTRUSION  1  1/86 (1.16%)  0/86 (0.00%) 
ROTATOR CUFF SYNDROME  1  0/86 (0.00%)  1/86 (1.16%) 
Nervous system disorders     
SYNCOPE  1  0/86 (0.00%)  1/86 (1.16%) 
Psychiatric disorders     
ANXIETY  1  0/86 (0.00%)  1/86 (1.16%) 
SUICIDE ATTEMPT  1  0/86 (0.00%)  1/86 (1.16%) 
Renal and urinary disorders     
CYSTITIS INTERSTITIAL  1  0/86 (0.00%)  1/86 (1.16%) 
URETEROLITHIASIS  1  0/86 (0.00%)  1/86 (1.16%) 
Respiratory, thoracic and mediastinal disorders     
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  0/86 (0.00%)  1/86 (1.16%) 
DYSPNOEA  1  0/86 (0.00%)  1/86 (1.16%) 
PULMONARY EMBOLISM  1  0/86 (0.00%)  1/86 (1.16%) 
Vascular disorders     
ORTHOSTATIC HYPOTENSION  1  0/86 (0.00%)  1/86 (1.16%) 
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Eleclazine 30/3/6 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   58/86 (67.44%)   62/86 (72.09%) 
Cardiac disorders     
ATRIAL FIBRILLATION  1  0/86 (0.00%)  6/86 (6.98%) 
PALPITATIONS  1  9/86 (10.47%)  11/86 (12.79%) 
VENTRICULAR TACHYCARDIA  1  2/86 (2.33%)  5/86 (5.81%) 
Gastrointestinal disorders     
NAUSEA  1  11/86 (12.79%)  11/86 (12.79%) 
General disorders     
CHEST DISCOMFORT  1  6/86 (6.98%)  3/86 (3.49%) 
CHEST PAIN  1  11/86 (12.79%)  9/86 (10.47%) 
FATIGUE  1  9/86 (10.47%)  7/86 (8.14%) 
Infections and infestations     
BRONCHITIS  1  1/86 (1.16%)  5/86 (5.81%) 
INFLUENZA  1  3/86 (3.49%)  5/86 (5.81%) 
NASOPHARYNGITIS  1  5/86 (5.81%)  11/86 (12.79%) 
UPPER RESPIRATORY TRACT INFECTION  1  7/86 (8.14%)  10/86 (11.63%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  4/86 (4.65%)  7/86 (8.14%) 
BACK PAIN  1  9/86 (10.47%)  6/86 (6.98%) 
MUSCLE SPASMS  1  5/86 (5.81%)  6/86 (6.98%) 
MUSCULOSKELETAL PAIN  1  0/86 (0.00%)  5/86 (5.81%) 
Nervous system disorders     
DIZZINESS  1  12/86 (13.95%)  14/86 (16.28%) 
HEADACHE  1  11/86 (12.79%)  11/86 (12.79%) 
HYPOAESTHESIA  1  1/86 (1.16%)  5/86 (5.81%) 
PRESYNCOPE  1  5/86 (5.81%)  8/86 (9.30%) 
Psychiatric disorders     
ANXIETY  1  5/86 (5.81%)  2/86 (2.33%) 
Respiratory, thoracic and mediastinal disorders     
COUGH  1  7/86 (8.14%)  5/86 (5.81%) 
DYSPNOEA  1  16/86 (18.60%)  8/86 (9.30%) 
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
The totality of the data did not support continuation of the eleclazine development program. So, this study was terminated prior to the end of the double-blind phase, and therefore no participants entered the open-label extension (OLE) period.
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.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Name/Title: Clinical Trial Disclosures & Data Transparency
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02291237     History of Changes
Other Study ID Numbers: GS-US-361-1157
2013-004429-97 ( EudraCT Number )
First Submitted: November 11, 2014
First Posted: November 14, 2014
Results First Submitted: January 19, 2018
Results First Posted: March 22, 2018
Last Update Posted: September 24, 2018