Hypertrophic Cardiomyopathy Clinical Trial

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

Summary

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).

View Eligibility Criteria

Eligibility 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

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 is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 2

Estimated Enrollment:

13

Study ID:

NCT03496168

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 4 Locations for this study

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Local Institution - 0003
Scottsdale Arizona, 85259, United States
Local Institution - 0001
New Haven Connecticut, 06520, United States
Local Institution - 0004
Durham North Carolina, 27710, United States
Local Institution - 0002
Portland Oregon, 97239, United States

How clear is this clinincal trial information?

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 2

Estimated Enrollment:

13

Study ID:

NCT03496168

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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