Status:
RECRUITING
A Study to Assess the Safety of Mavacamten in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Obstructive Hypertrophic Cardiomyopathy
Eligibility:
All Genders
19+ years
Brief Summary
The purpose of this observational post-marketing surveillance study is to assess the real-world safety of mavacamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in ...
Eligibility Criteria
Inclusion
- Adult participants 19 years of age or older
- Participants who receive mavacamten according to the approved product label
- Participants who sign the informed consent form
Exclusion
- Participants who are prescribed mavacamten for therapeutic indications not approved in Korea
- Participants for whom mavacamten is contraindicated as clarified in Korean prescribing information approved by the Ministry of Food and Drug Safety
Key Trial Info
Start Date :
July 24 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06146660
Start Date
July 24 2024
End Date
November 30 2026
Last Update
November 6 2024
Active Locations (2)
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1
Local Institution - 0001
Seoul, South Korea, 06234
2
Novotech Laboratory Korea Co., Ltd.
Seoul, South Korea, 06234