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

Description

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

Conditions

Cardiomyopathy, Hypertrophic

Study Overview

Study Details

Study overview

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

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

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

Condition
Cardiomyopathy, Hypertrophic
Intervention / Treatment

-

Contacts and Locations

Birmingham

The University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294-0004

Phoenix

Phoenix Children's Cardiology, Phoenix, Arizona, United States, 85016-7710

Los Angeles

Children's Hospital Los Angeles, Los Angeles, California, United States, 90027-6062

Los Angeles

University of California Los Angeles (UCLA) - Mattel Children's Hospital, Los Angeles, California, United States, 90095-8344

Oakland

Local Institution - 0004, Oakland, California, United States, 94609

Palo Alto

Lucile Packard Children's Hospital (LPCH), Palo Alto, California, United States, 94304-1601

San Diego

Local Institution - 0044, San Diego, California, United States, 92123-4223

Aurora

Children's Hospital Colorado, Aurora, Colorado, United States, 80045-7106

Saint Petersburg

Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, United States, 33701-4634

Atlanta

Children's Healthcare of Atlanta - Arthur M. Blank Hospital, Atlanta, Georgia, United States, 30329-3117

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

12 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bristol-Myers Squibb,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2031-03-28