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

Hypertrophic Cardiomyopathy Clinical Trial

— PIONEER-OLE  

Official title:

An Open-Label Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in Study MYK-461-004 (PIONEER)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03496168
• Other study ID #: CV027-008
• Status: Completed
• Phase: Phase 2
• Start date: April 26, 2018
• Est. completion date: November 9, 2023

Study information

• Verified date: January 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 9, 2023
• Est. primary completion date: November 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy

Intervention

Drug:
• mavacamten
mavacamten capsules

Locations

Country	Name	City	State
United States	Local Institution - 0004	Durham	North Carolina
United States	Local Institution - 0001	New Haven	Connecticut
United States	Local Institution - 0002	Portland	Oregon
United States	Local Institution - 0003	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and severity of adverse events and serious adverse events.		Up to 260 weeks

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting