CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 8,256 enrolled
Drug / intervention
Omecamtiv Mecarbil +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02929329
NCT02929329Phase 3Completed
CompareCT.gov

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)

Cytokinetics·interventional·Posted Oct 11, 2016·Updated Nov 5, 2021

In Brief

A Phase 3 clinical trial evaluating Omecamtiv Mecarbil, Placebo, and 1 other intervention for Heart Failure. Completed, enrolled 8,256 participants across 1,033 sites in 36 countries.

Detailed Summary

The purpose of this study is to determine if treatment with omecamtiv mecarbil 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 adults with chronic heart failure with reduced ejection fraction (HFrEF).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Portugal, Puerto Rico, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 11, 2016
Enrollment StartJan 6, 2017
Primary CompletionSep 14, 2020
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 9.7 years ago

Interventions

Omecamtiv Mecarbildrug

Omecamtiv mecarbil tablets for oral administration

Placebodrug

Matching placebo tablets

Standard of Caredrug

Participants were required to be optimally managed with standard of care therapies for chronic HF (eg, beta blockers, renin angiotensin aldosterone system inhibitors), consistent with regional clinical practice guidelines, unless contraindicated.