Trials / Withdrawn
WithdrawnNCT04464525
Omecamtiv Mecarbil Post-trial Access Study
Omecamtiv Mecarbil Post-trial Access Protocol for Subjects Completing Study 20110203 GALACTIC-HF
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Cytokinetics · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to provide access to omecamtiv mecarbil for participants who have completed GALACTIC-HF 20110203.
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 | Film-coated tablet administered orally. |
Timeline
- Start date
- 2020-12-18
- Primary completion
- 2026-11-27
- Completion
- 2026-11-27
- First posted
- 2020-07-09
- Last updated
- 2021-07-30
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04464525. Inclusion in this directory is not an endorsement.