Omecamtiv Mecarbil Post-trial Access Study

Chronic Heart Failure With Reduced Ejection Fraction Clinical Trial

Official title:

Omecamtiv Mecarbil Post-trial Access Protocol for Subjects Completing Study 20110203 GALACTIC-HF

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04464525
• Other study ID #: 20190370
• Status: Withdrawn
• Phase: Phase 3
• Start date: December 18, 2020
• Est. completion date: November 27, 2026

Study information

• Verified date: July 2021
• Source: Cytokinetics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to provide access to omecamtiv mecarbil for participants who have completed GALACTIC-HF 20110203.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 27, 2026
• Est. primary completion date: November 27, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Heart Failure With Reduced Ejection Fraction
• Heart Failure

Intervention

Drug:
• Omecamtiv mecarbil
Film-coated tablet administered orally.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cytokinetics

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participant incidence of serious adverse events and treatment emergent adverse events	Targeted adverse events are those which lead to temporary or permanent discontinuation of OM, adverse events that are possibly related to OM or study procedures, and all adverse events of myocardial infarction, myorcardial ischemia, and ventricular arrhythmia, irrespective of seriousness and relationship to OM.	Up to 252 weeks
Primary	Number of participants administered omecamtiv mecarbil during the treatment period	Primary analysis is based on the exploratory outcome measure.	Up to 252 weeks

External Links

•   AmgenTrials clinical trials website