A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction (GALACTIC-HF)

Galactic-HF [NCT02929329]

Description:  The purpose of this study is to determine if treatment with omecamtiv mecarbil/AMG 423 when added to standard of care is well tolerated and superior to placebo in reducing the risk of cardiovascular death or heart failure events in subjects with chronic HFrEF.

Drug: Omecamtiv Mecarbil
Drug: Placebo

Primary Investigator: Chung

Drug/Device Information
Drug: Omecamtiv Mecarbil
Drug: Placebo
To evaluate the effect of treatment with omecamtiv mecarbil (OM) compared with placebo on the time to cardiovascular event
OM (AMG 423, CK-1827452) is a novel small molecule classified as a cardiac myosin activator that increases cardiac contractility
Randomly assigned in a 1:1 ratio to 1 of 2 treatment groups (OM or placebo) in a double-blind manner
Subjects randomized to OM will initiate administration at 25 mg BID
Amgen Inc.