CMIC Co., Ltd
Tokyo, Japan
Location status: Recruiting
Recruiting
NCT Number: NCT07383025
Mavacamten Post-marketing Surveillance in Patients With Obstructive Hypertrophic Cardiomyopathy in Japan
The purpose of this study is to assess the real-world effectiveness and safety of mavacamten in patients with obstructive hypertrophic cardiomyopathy (HCM) receiving mavacamten in Japan
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- All obstructive hypertrophic cardiomyopathy (oHCM) patients who initiate treatment with Mavacamten of the approved indications at medical institutions in Japan during enrollment period will be enrolled in this regulatory post-marketing surveillance (PMS) study
Exclusion criteria
- Participants receiving Mavacamten for an off-label indication will be excluded from this PMS study
Treatment and study plan
Mavacamten
DrugAccording to the product label
Primary outcomes
-
Incidence of adverse events (AEs) and/or serious AEs (SAEs)
Time frame: Up to 52 weeks
-
Actions taken after adverse events (AEs) and/or serious AEs (SAEs)
Time frame: Up to 52 weeks
-
Outcome of adverse events (AEs) and/or serious AEs (SAEs)
Time frame: Up to 52 weeks
Study contacts
Contact information is provided by the study sponsor or research team.
BMS Study Connect Contact Center www.BMSStudyConnect.com
CONTACT
First line of the email MUST contain NCT # and Site #.
CONTACT
Sponsors and collaborators
Lead sponsor
Bristol-Myers Squibb
Industry
Registry information
Official study title
Mavacamten Post-marketing Surveillance in Patients With Obstructive Hypertrophic Cardiomyopathy (oHCM) in Japan
Important dates
- Study start
- 2025
- Primary completion
- 2029
- Study completion
- 2029
- First posted
- Feb 3, 2026
- Registry last updated
- Feb 3, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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