Clinical Trial: Effect of Eleclazine (GS-6615) on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
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: This study will evaluate the effect of eleclazine (GS-6615) on exercise capacity, quality of life, and safety and tolerability of eleclazine in participants with symptomatic hypertrophic cardiomyopathy (HCM).
Detailed Summary:
Sponsor: Gilead Sciences
Current Primary Outcome: Change in peak oxygen uptake (VO2) from baseline (screening) to Week 24 [ Time Frame: Up to 24 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) from baseline to Week 24 [ Time Frame: Up to 24 weeks ]
- Change in treadmill exercise time from baseline to Week 24 [ Time Frame: Up to 24 weeks ]
- Change in Peak VO2 from baseline to Week 12 [ Time Frame: Up to 12 weeks ]
- Change in the MLHFQ from baseline to Week 12 [ Time Frame: Up to 12 weeks ]
- Change in treadmill exercise time from baseline to Week 12 [ Time Frame: Up to 12 weeks ]
Original Secondary Outcome: Same as current
Information By: Gilead Sciences
Dates:
Date Received: November 11, 2014
Date Started: February 5, 2015
Date Completion:
Last Updated: February 24, 2017
Last Verified: February 2017
