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

NCT06146660 | Recruiting FDA Drug

• 1 other identifier: CV027-1089
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 2

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

Conditions

Obstructive Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  Up to 12 months

Study Arms (1)

Participants receiving mavacamten for oHCM

Drug: Mavacamten

Interventions

Mavacamten DRUG

According to approved product label

Participants receiving mavacamten for oHCM

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants diagnosed with symptomatic oHCM who will receive mavacamten according to the approved product label

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Local Institution - 0001

Seoul, 06234, South Korea

TERMINATED

Novotech Laboratory Korea Co., Ltd.

Seoul, 06234, South Korea

RECRUITING

Related Links

• BMS Clinical Trial Information

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

MYK-461

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 27, 2023
• Study Start: July 24, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)