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Clinical Trials in France / NCT06253221
Active, not recruiting Phase 3

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

NCT06253221 · tracked via the Priya Life Science France 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)

Mavacamten →Placebo

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
No
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)

FacilityCityRegionStatus
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 France