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Mavacamten Post-marketing Surveillance in Patients With Obstructive Hypertrophic Cardiomyopathy in Japan

Mavacamten Post-marketing Surveillance in Patients With Obstructive Hypertrophic Cardiomyopathy (oHCM) in Japan

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07383025
Enrollment
200
Registered
2026-02-03
Start date
2025-05-21
Completion date
2029-11-30
Last updated
2026-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Hypertrophic Cardiomyopathy (oHCM)

Keywords

Obstructive hypertrophic cardiomyopathy (oHCM)

Brief summary

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

Interventions

DRUGMavacamten

According to the product label

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frame
Incidence of adverse events (AEs) and/or serious AEs (SAEs)Up to 52 weeks
Actions taken after adverse events (AEs) and/or serious AEs (SAEs)Up to 52 weeks
Outcome of adverse events (AEs) and/or serious AEs (SAEs)Up to 52 weeks

Countries

Japan

Contacts

CONTACTBMS Study Connect Contact Center www.BMSStudyConnect.com
Clinical.Trials@bms.com855-907-3286
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol Myers Squibb

Bristol-Myers Squibb

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026