NCT06146660RecruitingNot Applicable
CAMZYOS® (Mavacamten) Post-Marketing Surveillance in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
Bristol-Myers Squibb2 sites in 1 country600 target enrollmentStarted: July 24, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 600
- Locations
- 2
- Primary Endpoint
- Number of participants with adverse events
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Participants receiving mavacamten for oHCM
Intervention: Mavacamten (Drug)
Outcomes
Primary Outcomes
Number of participants with adverse events
Time Frame: Up to 12 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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