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Clinical Trials in South Korea / NCT06146660
Recruiting Observational

A Study to Assess the Safety of Mavacamten in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy

NCT06146660 · tracked via the Priya Life Science South Korea tracker
Sponsor
Bristol-Myers Squibb
Phase
Observational
Started
2024-07-24
Last updated
2024-11-06

Condition(s) studied

Obstructive Hypertrophic Cardiomyopathy

Investigational drug(s) / intervention(s)

Mavacamten →

Mavacamten: According to approved product label

Study 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 adult participants in Korea. Participants who will receive at least 1 dose of mavacamten will be enrolled.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

  • Number of participants with adverse events — Up to 12 months

Trial sites (2)

FacilityCityRegionStatus
Local Institution - 0001 Seoul South Korea Terminated
Novotech Laboratory Korea Co., Ltd. Seoul South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06146660 on ClinicalTrials.gov ↗ ← All trials in South Korea