For Healthcare Professionals

Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER

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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).
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Completed Study MYK-461-004. Prior participation in a non-interventional observational study is allowed.
  2. Body weight > 45 kg at Screening
  3. Has safety laboratory parameters (chemistry and hematology) within normal limits Key

EXCLUSION CRITERIA

  1. 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)
  2. 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
  3. 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
  4. Since enrollment into Study MYK-461-004 has developed clinically significant malignant disease
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall (650) 741-0900Email iconEmail Study Center

Study’s details


Contition

Hypertrophic Cardiomyopathy,Obstructive Hypertrophic Cardiomyopathy

Age

18+

Phase

Phase 2

Participants needed

13

Est. Completion Date

Nov 2023

Treatment type

Interventional


Sponsor

Bristol-Myers Squibb

ClinicalTrials.gov identifier

NCT03496168

Study number

CV027-008

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