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

Bristol-Myers Squibb600 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Obstructive Hypertrophic Cardiomyopathy

Interventions

MavacamtenDRUG

According to approved product label

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (2)

Local Institution - 0001

Seoul, South Korea

TERMINATED

Novotech Laboratory Korea Co., Ltd.

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Number of participants with adverse events

Time frame: Up to 12 months

Central Contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Data from ClinicalTrials.gov

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