A Study of Mavacamten in Adults With Obstructive Hypertrophic Cardiomyopathy in India (ROVER)

Sponsor
Bristol-Myers Squibb
Study ID
NCT07004972
Phase
PHASE4
Status
Active Not Recruiting

Conditions

  • Symptomatic Obstructive Hypertrophic Cardiomyopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mavacamten — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to evaluate the safety, tolerability and effectiveness of mavacamten in adults with obstructive hypertrophic cardiomyopathy in India.

Key Dates

Start date
Sep 4, 2025
Status verified
Apr 2026
Primary completion
Dec 13, 2027
Completion
Dec 13, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Mavacamten

Primary Outcome Measure

Incidence of serious Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to Week 48 ]

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