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

Brief Title

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

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

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).
    


Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 24

Secondary Outcome

 Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 12

Condition

Hypertrophic Cardiomyopathy

Intervention

Eleclazine

Study Arms / Comparison Groups

 Eleclazine
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

172

Start Date

February 5, 2015

Completion Date

February 17, 2017

Primary Completion Date

January 20, 2017

Eligibility 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.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Gilead Study Director, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT02291237

Organization ID

GS-US-361-1157

Secondary IDs

2013-004429-97

Responsible Party

Sponsor

Study Sponsor

Gilead Sciences


Study Sponsor

Gilead Study Director, Study Director, Gilead Sciences


Verification Date

February 2018