A Study of Mavacamten in Obstructive Hypertrophic Cardiomyopathy

Sponsor
Bristol-Myers Squibb
Study ID
NCT05414175
Phase
PHASE3
Status
Completed

Conditions

  • Cardiomyopathy, Hypertrophic Obstructive

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Mavacamten — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to evaluate the effectiveness, safety, and tolerability of a 30-week course of mavacamten and the long-term effects of mavacamten in Japanese participants with symptomatic obstructive hypertrophic cardiomyopathy (HCM).

Key Dates

Start date
Aug 19, 2022
Status verified
Jan 2026
Primary completion
Nov 27, 2023
Completion
Dec 11, 2025

Study Design

Enrollment
38 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Mavacamten

Primary Outcome Measure

Change From Baseline in Post-exercise Left Ventricular Outflow Tract (LVOT) Peak Gradient at Week 30 [ Time Frame: At Baseline and Week 30 ]