Trial · NCT02291237

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

NCT02291237, Phase 2, Phase 3, Terminated, Gilead Sciences; results first posted 2018-03-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effect of Eleclazine (GS-6615) on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy. Trials, record NCT02291237. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02291237

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effect of Eleclazine (GS-6615) on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy
NCT number: NCT02291237
Status: Terminated
Phases: Phase 2, Phase 3
Enrollment: 172 participants, actual
Lead sponsor: Gilead Sciences
Conditions: Hypertrophic Cardiomyopathy
Interventions: Eleclazine, Placebo
First posted: 2014-11-14
Last updated: 2018-09-24
Other registries' IDs: eudract:2013-004429-97
Results first posted: 2018-03-22
Limitations and caveats: 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.

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 24	Baseline to Week 24
Secondary	Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 12	Baseline to Week 12
Secondary	Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 24	Baseline to Week 24	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.
Secondary	Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 12	Baseline to Week 12	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.
Secondary	Change in Treadmill Exercise Time From Baseline to Week 24	Baseline to Week 24	Treadmill exercise time is the time to peak exercise.
Secondary	Change in Treadmill Exercise Time From Baseline to Week 12	Baseline to Week 12	Treadmill exercise time is the time to peak exercise.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 24	Baseline to Week 24	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.	mL/kg/min	MEAN
SECONDARY	Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 12	Baseline to Week 12	Participants in the Full Analysis Set with available data were analyzed.	mL/kg/min	MEAN
SECONDARY	Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 24	Baseline to Week 24	Participants in the Full Analysis Set with available data were analyzed.	Score	MEAN
SECONDARY	Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 12	Baseline to Week 12	Participants in the Full Analysis Set with available data were analyzed.	Score	MEAN
SECONDARY	Change in Treadmill Exercise Time From Baseline to Week 24	Baseline to Week 24	Participants in the Full Analysis Set with available data were analyzed.	min	MEAN
SECONDARY	Change in Treadmill Exercise Time From Baseline to Week 12	Baseline to Week 12	Participants in the Full Analysis Set with available data were analyzed.	min	MEAN

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 24	Eleclazine 30/3/6 mg		0.15	Standard Deviation 4.312	mL/kg/min
Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 24	Placebo		0.48	Standard Deviation 4.143	mL/kg/min
Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 12	Eleclazine 30/3/6 mg		0.28	Standard Deviation 4.028	mL/kg/min
Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 12	Placebo		0.57	Standard Deviation 4.314	mL/kg/min
Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 24	Eleclazine 30/3/6 mg	Baseline	40.22	Standard Deviation 25.544	Score
Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 24	Placebo	Baseline	38.80	Standard Deviation 23.177	Score
Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 24	Eleclazine 30/3/6 mg	Change from Baseline at Week 24	-4.05	Standard Deviation 15.164	Score
Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 24	Placebo	Change from Baseline at Week 24	-5.57	Standard Deviation 14.345	Score
Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 12	Eleclazine 30/3/6 mg	Baseline	40.22	Standard Deviation 25.544	Score
Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 12	Placebo	Baseline	38.80	Standard Deviation 23.177	Score

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Eleclazine 30/3/6 mg	86
Overall Study	STARTED	Placebo	86
Overall Study	COMPLETED	Eleclazine 30/3/6 mg	0
Overall Study	COMPLETED	Placebo	0
Overall Study	NOT COMPLETED	Eleclazine 30/3/6 mg	86
Overall Study	NOT COMPLETED	Placebo	86

Source ClinicalTrials.gov

Adverse events124

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	ATRIAL FIBRILLATION	Cardiac disorders	Eleclazine 30/3/6 mg	0	86
other	ATRIAL FIBRILLATION	Cardiac disorders	Placebo	6	86
other	PALPITATIONS	Cardiac disorders	Eleclazine 30/3/6 mg	9	86
other	PALPITATIONS	Cardiac disorders	Placebo	11	86
other	VENTRICULAR TACHYCARDIA	Cardiac disorders	Eleclazine 30/3/6 mg	2	86
other	VENTRICULAR TACHYCARDIA	Cardiac disorders	Placebo	5	86
other	NAUSEA	Gastrointestinal disorders	Eleclazine 30/3/6 mg	11	86
other	NAUSEA	Gastrointestinal disorders	Placebo	11	86
other	CHEST DISCOMFORT	General disorders	Eleclazine 30/3/6 mg	6	86
other	CHEST DISCOMFORT	General disorders	Placebo	3	86

1 to 10 of 124Source ClinicalTrials.gov

See all 124 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Eleclazine 30/3/6 mg	0	86
Total, all-cause mortality	Placebo	0	86
Total, other adverse events	Eleclazine 30/3/6 mg	58	86
Total, other adverse events	Placebo	62	86
Total, serious adverse events	Eleclazine 30/3/6 mg	14	86
Total, serious adverse events	Placebo	16	86

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26915375	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Eleclazine 30/3/6 mg vs Placebo: deaths from any cause	Trial comparisons
Eleclazine 30/3/6 mg vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02291237

GET https://conductscience.org/api/trials/v1/NCT02291237/events?page=2

API reference For AI assistants