Registrational Study With Omecamtiv Mecarbil/AMG 423 to Treat Chronic Heart Failure With Reduced Ejection Fraction (GALACTIC-HF)
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.
Study phase: III
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
Male or female, ? 18 to ? 85 years
History of chronic HF (defined as requiring treatment for HF for a minimum of 30 days before randomization)
LVEF ? 35%, not in the setting of acute decompensation
NYHA class II to IV
Managed with HF SoC therapies consistent with regional clinical practice guidelines according to investigator judgment of subject's clinical status
Current hospitalization with primary reason of HF or prior HF hospitalization, or urgent HF admission to emergency department (ED) within 1 year prior to screening
Elevated BNP or NT-proBNP
Primary disease category: Heart/Cardiovascular
Sponsor: Amgen, Inc.
Projected enrollment dates: February 2016 to February 2020
Official study title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study toAssess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidityin Subjects With Chronic Heart Failure With Reduced Ejection Fraction