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

Bristol-Myers Squibb13 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertrophic Cardiomyopathy

Interventions

mavacamtenDRUG

mavacamten capsules

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Local Institution - 0003

Scottsdale, Arizona, United States

Local Institution - 0001

New Haven, Connecticut, United States

Local Institution - 0004

Durham, North Carolina, United States

Local Institution - 0002

Portland, Oregon, United States

Outcomes

Primary Outcomes

Number of Participants With Treatment Emergent Adverse Events and Treatment Emergent Serious Adverse Events

AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence at any dose that: * Results in death * Is immediately life-threatening (places the participant at immediate risk of death from the event as it occurred) * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions * Results in a congenital abnormality or birth defect * Is an important medical event that may not result in death, be life- threatening, or require hospitalization, but may be considered an SAE when, based upon appropriate medical judgment, it may require medical or surgical intervention to prevent any of the outcomes listed above.

Time frame: From first dose to end of treatment + 56 days (Approximately an average of 240 Weeks)

Number of Participants Who Had Cardiovascular Death

Number of participants who had died due to cardiovascular reasons.