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NCT06146660 | RECRUITING | Obstructive Hypertrophic Cardiomyopathy

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

Bristol-Myers Squibb

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.

Condition or disease

Obstructive Hypertrophic Cardiomyopathy

Intervention/treatment

Mavacamten

Study Type : OBSERVATIONAL
Estimated Enrollment : 600 participants
Official Title : CAMZYOS® (Mavacamten) Post-Marketing Surveillance in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
Actual Study Start Date : 2024-07-24
Estimated Primary Completion Date : 2026-11-30
Estimated Study Completion Date : 2026-11-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 19 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
A Study to Assess the Safety of Mavacamten in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Location Details

NCT06146660

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

TERMINATED

Korea, Republic of,

Local Institution - 0001

Seoul, Korea, Republic of, 06234

RECRUITING

Korea, Republic of,

Novotech Laboratory Korea Co., Ltd.

Seoul, Korea, Republic of, 06234