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

a study on Cardiomyopathy

Summary

Eligibility
for people ages 12-17 (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

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).

Official Title

A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adolescents (Age 12 Years to < 18 Years) With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Keywords

Cardiomyopathy, Hypertrophic, HCM, mavacamten, Obstructive Hypertrophic Cardiomyopathy, SCOUT, SCOUT-HCM, Pediatric HCM, Pediatric hypertrophic cardiomyopathy, Symptomatic HCM, oHCM, Cardiomyopathies, Hypertrophic Cardiomyopathy, Hypertrophy

Eligibility

You can join if…

Open to people ages 12-17

  • Diagnosis of HCM
  • Presence of LVOT obstruction
  • Presence of symptoms

You CAN'T join if...

  • 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.

Locations

  • University of California Los Angeles (UCLA) - Mattel Children's Hospital accepting new patients
    Los Angeles California 90095-8344 United States
  • Local Institution - 0044 not yet accepting patients
    San Diego California 92123-4223 United States
  • Children's Hospital Los Angeles accepting new patients
    Los Angeles California 90027-6062 United States
  • Local Institution - 0004 withdrawn
    Oakland California 94609 United States
  • Lucile Packard Children's Hospital (LPCH) accepting new patients
    Palo Alto California 94304-1601 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT06253221
Phase
Phase 3 Cardiomyopathy Research Study
Study Type
Interventional
Participants
Expecting 40 study participants
Last Updated