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

Phase 2/3 Terminated 172 enrolled Gilead Sciences

RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start: 2015-02-05
Primary completion: 2017-01-20
Completion: 2017-02-17

Outcome

Missed primary endpoint

registry analysis (superiority test); Eleclazine 30/3/6 mg vs Placebo; p = 0.416; LS Mean Difference(Eleclazine - Placebo) -0.55 (95% CI -1.87 to 0.78); ANCOVA NCT02291237 ↗

Publications

Background Olivotto I, Hellawell JL, Farzaneh-Far R, Blair C, Coppini R, Myers J, Belardinelli L, Maron MS. Novel Approach Targeting the Complex Pathophysiology of Hypertrophic Cardiomyopathy: The Impact of Late Sodium Current Inhibition on Exercise Capacity in Subjects with Symptomatic Hypertrophic Cardiomyopathy (LIBERTY-HCM) Trial. Circ Heart Fail. 2016 Mar;9(3):e002764. doi: 10.1161/CIRCHEARTFAILURE.115.002764.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Eleclazine	Small molecule	6 mg	Oral