NCT06146660Recruiting
A Study to Assess the Safety of Mavacamten in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
CAMZYOS® (Mavacamten) Post-Marketing Surveillance in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
Source: ClinicalTrials.gov · Last updated 6 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 15 Nov 2023
- Start date
- 24 Jul 2024
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Hypertrophic cardiomyopathy
- NCT number
- NCT06146660
What you commit to
- Study type: Observational
- Planned participants: 600
- From 24 Jul 2024 to the primary completion date, 30 Nov 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants for whom mavacamten is contraindicated as clarified in Korean prescribing information approved by the Ministry of Food and Drug Safety
Other
- Participants who are prescribed mavacamten for therapeutic indications not approved in Korea
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novotech Laboratory Korea Co., Ltd. Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Terminated |
This page is information, not medical advice. Discuss any trial with your doctor.