NCT04464525WithdrawnPhase 3
Omecamtiv Mecarbil Post-trial Access Protocol for Subjects Completing Study 20110203 GALACTIC-HF
Cytokinetics0 sitesStarted: December 18, 2020Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- Number of participants administered omecamtiv mecarbil during the treatment period
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participant has provided GALACTIC-HF PTA informed consent prior to initiation of any study specific activities/procedures.
- •Participant has completed GALACTIC-HF.
Exclusion Criteria
- •Investigational product was permanently discontinued during GALACTIC-HF due to protocol-specified reason.
- •Female participant is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 5 days after the last dose of treatment.
- •Female participants of childbearing potential unwilling to use 2 acceptable methods of effective contraception during treatment with OM and for an additional 5 days after the last dose of treatment.
- •Female participants of childbearing potential with a positive pregnancy test assessed on day 1 by a urine pregnancy test.
- •Participant has known sensitivity to any of the products or components to be administered during dosing.
- •History or evidence of any clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion.
Arms & Interventions
Omecamtiv mecarbil
Experimental
All subjects will be assigned to OM
Intervention: Omecamtiv mecarbil (Drug)
Outcomes
Primary Outcomes
Number of participants administered omecamtiv mecarbil during the treatment period
Time Frame: Up to 252 weeks
Primary analysis is based on the exploratory outcome measure.
Secondary Outcomes
No secondary outcomes reported
Investigators
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