Mavacamten Post-marketing Surveillance in Patients With Obstructive Hypertrophic Cardiomyopathy in Japan

Bristol-Myers Squibb200 enrolled

Overview

The purpose of this study is to assess the real-world effectiveness and safety of mavacamten in patients with obstructive hypertrophic cardiomyopathy (HCM) receiving mavacamten in Japan

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Obstructive Hypertrophic Cardiomyopathy (oHCM)

Interventions

MavacamtenDRUG

According to the product label

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: • All obstructive hypertrophic cardiomyopathy (oHCM) patients who initiate treatment with Mavacamten of the approved indications at medical institutions in Japan during enrollment period will be enrolled in this regulatory post-marketing surveillance (PMS) study Exclusion Criteria: • Participants receiving Mavacamten for an off-label indication will be excluded from this PMS study

Locations (1)

CMIC Co., Ltd

Tokyo, Japan

RECRUITING

Outcomes

Primary Outcomes

Incidence of adverse events (AEs) and/or serious AEs (SAEs)

Time frame: Up to 52 weeks

Actions taken after adverse events (AEs) and/or serious AEs (SAEs)

Time frame: Up to 52 weeks

Outcome of adverse events (AEs) and/or serious AEs (SAEs)

Time frame: Up to 52 weeks

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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