Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER
About the study
This is a multicenter open-label study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM) who previously participated in study MYK-461-004 (PIONEER-HCM).
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Key Inclusion Criteria:
- Completed Study MYK-461-004. Prior participation in a non-interventional observational study is allowed.
- Body weight > 45 kg at Screening
- Has safety laboratory parameters (chemistry and hematology) within normal limits
EXCLUSION CRITERIA
Key Exclusion Criteria:
- Has QTcF > > 500 ms or any other ECG abnormality considered by the investigator to pose a risk to subject safety (eg, second degree atrioventricular block type II)
- Since enrollment into Study MYK-461-004, has developed obstructive coronary artery disease (> 70% stenosis in one or more arteries) or known moderate or severe aortic valve stenosis
- Since enrollment into Study MYK-461-004, has developed any acute or serious comorbid condition (eg, major infection or hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction) that, in the opinion of the investigator or medical monitor, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
- Since enrollment into Study MYK-461-004 has developed clinically significant malignant disease
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Hypertrophic Cardiomyopathy
Age (in years)
18+
Phase
Phase 2
Participants needed
13
Est. Completion Date
Nov 9, 2023
Treatment type
Interventional
Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov identifier
NCT03496168
Study number
CV027-008
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