NCT02291237

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

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hypertrophic Cardiomyopathy

Interventions

Type	Name	Description
DRUG	Eleclazine	Tablet (s) administered orally once daily
DRUG	Placebo	Placebo to match eleclazine administered orally once daily

Timeline

• Start date: 2015-02-05
• Primary completion: 2017-01-20
• Completion: 2017-02-17
• First posted: 2014-11-14
• Last updated: 2018-09-24
• Results posted: 2018-03-22

Locations

46 sites across 8 countries: United States, Australia, France, Germany, Israel, Italy, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study