Omecamtiv Mecarbil Post-trial Access Study

Cytokinetics

Status and phase

Withdrawn

Phase 3

Conditions

Chronic Heart Failure With Reduced Ejection Fraction

Treatments

Drug: Omecamtiv mecarbil

Study type

Interventional

Funder types

Industry

Identifiers

NCT04464525

20190370

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.