A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic Cardiomyopathy

NCT06253221 · tracked via the Priya Life Science UK tracker

Sponsor

Bristol-Myers Squibb

Phase

Phase 3

Started

2024-04-17

Last updated

2025-12-19

Condition(s) studied

Cardiomyopathy, Hypertrophic

Investigational drug(s) / intervention(s)

MavacamtenPlacebo

Mavacamten: Specified dose on specified days

Placebo: Specified dose on specified days

Study summary

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of mavacamten in adolescent patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM).

Eligibility

Sex

ALL

Min age

12 Years

Max age

17 Years

Healthy volunteers

Inclusion Criteria: * Diagnosis of HCM * Presence of LVOT obstruction * Presence of symptoms Exclusion Criteria: * Phenocopy diseases resulting in myocardial hypertrophy not related to sarcomere dysfunction * Evidence of LVEF \<50% in prior 6 months * Planned escalation in HCM therapy or upcoming intervention (eg, major cardiac surgery, HCM medication dose increase) Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcome measure(s)

Change from baseline in Valsalva left ventricular outflow tract (LVOT) (VLVOT) gradient — At Week 28

Trial sites (47)

Facility	City	Region
Local Institution - 0017	Birmingham	Alabama
Local Institution - 0050	Phoenix	Arizona
Local Institution - 0032	Los Angeles	California
Local Institution - 0008	Los Angeles	California
Local Institution - 0033	Palo Alto	California
Local Institution - 0044	San Diego	California
Local Institution - 0038	Aurora	Colorado
Local Institution - 0031	St. Petersburg	Florida
Local Institution - 0053	Atlanta	Georgia
Local Institution - 0013	Chicago	Illinois
Local Institution - 0009	Indianapolis	Indiana
Local Institution - 0043	Boston	Massachusetts
Local Institution - 0002	Ann Arbor	Michigan
Local Institution - 0037	St Louis	Missouri
Local Institution - 0052	Morristown	New Jersey
Local Institution - 0010	New Hyde Park	New York
Local Institution - 0024	New York	New York
Local Institution - 0036	New York	New York
Local Institution - 0040	The Bronx	New York
Local Institution - 0015	Charlotte	North Carolina
Local Institution - 0039	Durham	North Carolina
Local Institution - 0019	Cincinnati	Ohio
Local Institution - 0001	Cleveland	Ohio
Local Institution - 0029	Columbus	Ohio
Local Institution - 0030	Philadelphia	Pennsylvania
Local Institution - 0005	Pittsburgh	Pennsylvania
Local Institution - 0034	Memphis	Tennessee
Local Institution - 0045	Austin	Texas
Local Institution - 0054	Houston	Texas
Local Institution - 0003	Salt Lake City	Utah
Local Institution - 0012	Charlottesville	Virginia
Local Institution - 0020	Sydney	New South Wales
Local Institution - 0042	Clayton	Victoria
Local Institution - 0041	Edmonton	Alberta
Local Institution - 0046	Toronto	Ontario
Local Institution - 0022	Paris	France
Local Institution - 0026	Pessac	France
Local Institution - 0006	Munich	Bavaria
Local Institution - 0018	Berlin	State of Berlin
Local Institution - 0047	Dublin 12, D12 N512	Ireland

+ 7 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06253221 on ClinicalTrials.gov ↗ ← All trials in the UK