Trials / Completed
CompletedNCT02929329
Registrational Study With Omecamtiv Mecarbil (AMG 423) to Treat Chronic Heart Failure With Reduced Ejection Fraction
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 8,256 (actual)
- Sponsor
- Cytokinetics · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021 and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics, Cytokinetics is now listed as the sponsor.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Omecamtiv Mecarbil | Omecamtiv mecarbil tablets for oral administration |
| DRUG | Placebo | Matching placebo tablets |
| DRUG | Standard of Care | 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. |
Timeline
- Start date
- 2017-01-06
- Primary completion
- 2020-09-14
- Completion
- 2020-09-14
- First posted
- 2016-10-11
- Last updated
- 2021-11-05
- Results posted
- 2021-07-20
Locations
1,033 sites across 36 countries: United States, Argentina, 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
Source: ClinicalTrials.gov record NCT02929329. Inclusion in this directory is not an endorsement.