Evaluate effect of GS6615 on Exercise capacity in subjects with HCM
Research type
Research Study
Full 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
IRAS ID
155632
Contact name
Perry Mark Elliott
Contact email
Sponsor organisation
Gilead Sciences, Inc
Eudract number
2013-004429-97
Duration of Study in the UK
4 years, 3 months, 30 days
Research summary
This is a phase 2/3, randomized, double-blind, placebo-controlled, global, multicentre study to evaluate the effect of GS 6615 on exercise capacity in subjects with symptomatic Hypertrophic Cardiomyopathy (HCM).
GS-6615 is a new investigational drug that is a potent and selective inhibitor of the cardiac late inward sodium current. GS-6615 is expected to improve the electrical and mechanical problems of the heart in HCM. There is no guarantee that participants will receive personal benefit from taking part in this study, however, this study will provide important information regarding a novel treatment for symptomatic HCM, an important unmet medical need with no approved therapies.
The investigational drug GS-6615 is being developed and sponsored by Gilead Sciences, Inc. and has been previously tested in humans.
The purpose of this study is to see if GS-6615 improves the symptoms of HCM and helps the heart pump better.
Participants will be assigned in a 1:1 ratio to either the GS-6615 treatment arm (single loading dose of 30mg GS-6615 followed by once daily dose of 6mg GS-6615) or matching placebo treatment arm.
This study has 2 parts. The first part of the study is a randomized, double-blind, and placebo-controlled study treatment period. The study duration is at least 32 weeks with at least 8 scheduled visits. After the last participant completes the first part of the study (end of Week 24 visit), the Investigator will decide if participants may continue into the second part of the study. During the second part of the study all participants will receive open-label GS-6615 and will have periodic study visits until the study ends.
Approximately 180 participants from 40-50 sites worldwide will participate. Approximately 16 participants will be recruited in the UK.REC name
London - Harrow Research Ethics Committee
REC reference
15/LO/0040
Date of REC Opinion
24 Mar 2015
REC opinion
Further Information Favourable Opinion