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
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Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
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Tracking Information | |||||
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First Submitted Date ICMJE | November 11, 2014 | ||||
First Posted Date ICMJE | November 14, 2014 | ||||
Results First Submitted Date ICMJE | January 19, 2018 | ||||
Results First Posted Date ICMJE | March 22, 2018 | ||||
Last Update Posted Date | September 24, 2018 | ||||
Actual Study Start Date ICMJE | February 5, 2015 | ||||
Actual Primary Completion Date | January 20, 2017 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 24 [ Time Frame: Baseline to Week 24 ] | ||||
Original Primary Outcome Measures ICMJE |
Change in peak oxygen uptake (VO2) from baseline (screening) to Week 24 [ Time Frame: Up to 24 weeks ] | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Effect of Eleclazine (GS-6615) on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy | ||||
Official Title ICMJE | Study Title: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of GS-6615 on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy | ||||
Brief Summary | The primary objective of this study was to evaluate the effect of eleclazine (GS-6615) on exercise capacity as measured by Peak oxygen uptake (VO2) achieved during cardiopulmonary exercise testing (CPET), in participants with symptomatic hypertrophic cardiomyopathy (HCM). | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Hypertrophic Cardiomyopathy | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Olivotto I, Hellawell JL, Farzaneh-Far R, Blair C, Coppini R, Myers J, Belardinelli L, Maron MS. Novel Approach Targeting the Complex Pathophysiology of Hypertrophic Cardiomyopathy: The Impact of Late Sodium Current Inhibition on Exercise Capacity in Subjects with Symptomatic Hypertrophic Cardiomyopathy (LIBERTY-HCM) Trial. Circ Heart Fail. 2016 Mar;9(3):e002764. doi: 10.1161/CIRCHEARTFAILURE.115.002764. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE |
172 | ||||
Original Estimated Enrollment ICMJE |
180 | ||||
Actual Study Completion Date ICMJE | February 17, 2017 | ||||
Actual Primary Completion Date | January 20, 2017 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Australia, France, Germany, Israel, Italy, Netherlands, United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02291237 | ||||
Other Study ID Numbers ICMJE | GS-US-361-1157 2013-004429-97 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Gilead Sciences | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Gilead Sciences | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Gilead Sciences | ||||
Verification Date | February 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |