Obstructive Hypertrophic Cardiomyopathy Clinical Trial
Official title:
CAMZYOS® (Mavacamten) Post-Marketing Surveillance in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
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.
| Status | Not yet recruiting |
| Enrollment | 600 |
| Est. completion date | November 30, 2026 |
| Est. primary completion date | November 30, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Bristol-Myers Squibb YH | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants with adverse events | Up to 12 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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