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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03496168
Other study ID # CV027-008
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
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