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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

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).

Condition or disease Intervention/treatment Phase
Hypertrophic Cardiomyopathy Drug: Eleclazine Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 5, 2015
Actual Primary Completion Date : January 20, 2017
Actual Study Completion Date : February 17, 2017


Arm Intervention/treatment
Experimental: Eleclazine
Eleclazine 30 mg single loading dose followed by 3 mg daily maintenance dose up until Week 12, then 6 mg daily maintenance dose from Week 12 at least Week 24, followed by eleclazine 6 mg in an open-label extension period.
Drug: Eleclazine
Tablet (s) administered orally once daily
Other Name: GS-6615

Experimental: Placebo
Placebo to match eleclazine until at least Week 24, followed by active eleclazine 6 mg in an open-label extension period.
Drug: Eleclazine
Tablet (s) administered orally once daily
Other Name: GS-6615

Drug: Placebo
Placebo to match eleclazine administered orally once daily




Primary Outcome Measures :
  1. Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 24 [ Time Frame: Baseline to Week 24 ]

Secondary Outcome Measures :
  1. Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ]
  2. Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 24 [ Time Frame: 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.

  3. Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 12 [ Time Frame: 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.

  4. Change in Treadmill Exercise Time From Baseline to Week 24 [ Time Frame: Baseline to Week 24 ]
    Treadmill exercise time is the time to peak exercise.

  5. Change in Treadmill Exercise Time From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ]
    Treadmill exercise time is the time to peak exercise.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Established diagnosis of hypertrophic cardiomyopathy defined by standard criteria as a maximal left ventricular wall thickness ≥ 15 mm at initial diagnosis
  • Exertional symptoms including at least one of the following:

    • New York Heart Association (NYHA) Class ≥ II dyspnea
    • Canadian Cardiovascular Society (CCS) Class ≥ II angina
  • Screening (baseline) peak VO2 < 80% of predicted for age, sex, and weight
  • Ability to perform an upright treadmill cardiopulmonary exercise test (CPET)

Key Exclusion Criteria:

  • Known aortic valve stenosis (moderate or severe)
  • Known coronary artery disease
  • Left ventricular systolic dysfunction (ejection fraction < 50%)
  • Recent septal reduction procedure (ie, surgical myectomy or alcohol septal ablation) within six months prior to screening or such a procedure scheduled to occur during the study

Note: Other protocol defined Inclusion/Exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291237


  Show 46 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
  Study Documents (Full-Text)

Documents provided by Gilead Sciences:
Study Protocol: Original  [PDF] April 1, 2014
Study Protocol: Amendment 1  [PDF] October 10, 2014
Study Protocol: Amendment 2  [PDF] February 10, 2015
Study Protocol: Amendment 3  [PDF] August 12, 2016
Statistical Analysis Plan  [PDF] May 10, 2017


Publications:
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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 Posted: November 14, 2014    Key Record Dates
Results First Posted: March 22, 2018
Last Update Posted: September 24, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gilead Sciences:
hypertrophic cardiomyopathy
hcm
hocm
hypertrophic myocardiopathy
hypertrophic obstructive cardiomyopathies
cardiomyopathy
hypertrophic
familial hypertrophic cardiomyopathy
genetic heart disease
echocardiography
cardiopulmonary exercise testing
exercise Capacity
heart failure
angina
dyspnea
diastolic dysfunction
microvascular ischemia
late sodium current inhibitor
GS-6615
late INA

Additional relevant MeSH terms:
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Cardiomyopathies
Hypertrophy
Cardiomyopathy, Hypertrophic
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases