Chronic Heart Failure With Reduced Ejection Fraction
Conditions
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.
Interventions
Film-coated tablet administered orally.
Sponsors
Cytokinetics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants administered omecamtiv mecarbil during the treatment period | Up to 252 weeks | Primary analysis is based on the exploratory outcome measure. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Participant incidence of serious adverse events and treatment emergent adverse events | Up to 252 weeks | 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. |
Outcome results
None listed