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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-26

Study Completion Date

2023-11-09

Brief Summary

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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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Detailed Description

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Conditions

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Hypertrophic Cardiomyopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mavacamten (MYK-461)

Group Type EXPERIMENTAL

mavacamten

Intervention Type DRUG

mavacamten capsules

Interventions

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mavacamten

mavacamten capsules

Intervention Type DRUG

Other Intervention Names

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MYK-461

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No