Actively Recruiting
CAMZYOS® (Mavacamten) Post-Marketing Surveillance in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Led by Bristol-Myers Squibb · Updated on 2024-11-06
600
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an observational post-marketing surveillance study to evaluate the real-world safety of mavacamten in adult patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in Korea. The study focuses on adults who are prescribed mavacamten for this condition and aims to monitor adverse events associated with the treatment. Participants will receive mavacamten according to the approved product label. This study enrolls individuals who have been prescribed mavacamten and will track their treatment over time without altering their prescribed care. During the study, researchers will monitor participants for up to 12 months to record any adverse events experienced. Data on safety will be collected through regular assessments, and participants will be observed in their usual care settings. The total duration of follow-up is up to one year after starting mavacamten treatment.
CONDITIONS
Brief Title
A Study to Assess the Safety of Mavacamten in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 months
Participants receive mavacamten according to the approved product label and are observed for safety.
Participants have visits as needed during treatment for safety monitoring
Trial Site Locations
Total: 2 locations
1
Local Institution - 0001
Seoul, South Korea, 06234
Terminated
2
Novotech Laboratory Korea Co., Ltd.
Seoul, South Korea, 06234
Actively Recruiting
Research Team
B
BMS Study Connect Contact Center www.BMSStudyConnect.com
F
First line of the email MUST contain NCT # and Site #.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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