Omecamtiv Mecarbil Post-trial Access Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04464525|
Recruitment Status : Not yet recruiting
First Posted : July 9, 2020
Last Update Posted : July 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Heart Failure With Reduced Ejection Fraction||Drug: Omecamtiv mecarbil||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||900 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Omecamtiv Mecarbil Post-trial Access Protocol for Subjects Completing Study 20110203 GALACTIC-HF|
|Estimated Study Start Date :||October 12, 2020|
|Estimated Primary Completion Date :||October 9, 2026|
|Estimated Study Completion Date :||October 9, 2026|
Experimental: Omecamtiv mecarbil
All subjects will be assigned to OM
Drug: Omecamtiv mecarbil
Film-coated tablet administered orally.
Other Name: AMG 423
- 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.
- Participant incidence of serious adverse events and treatment emergent adverse events [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04464525
|Contact: Amgen Call Centerfirstname.lastname@example.org|