Status:
WITHDRAWN
Omecamtiv Mecarbil Post-trial Access Study
Lead Sponsor:
Cytokinetics
Conditions:
Chronic Heart Failure With Reduced Ejection Fraction
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
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 subsequen...
Eligibility Criteria
Inclusion
- Participant has provided GALACTIC-HF PTA informed consent prior to initiation of any study specific activities/procedures.
- Participant has completed GALACTIC-HF.
Exclusion
- 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.
Key Trial Info
Start Date :
December 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04464525
Start Date
December 18 2020
End Date
November 27 2026
Last Update
July 30 2021
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.