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

Purpose

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

Condition

  • Cardiomyopathy, Hypertrophic

Eligibility

Eligible Ages
Between 12 Years and 17 Years
Eligible Genders
All
Accepts 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Mavacamten 		Participants assigned to this arm will receive mavacamten (1 mg to 15 mg) from day 1 to end of treatment at week 200.
  • Drug: Mavacamten
    Specified dose on specified days
    Other names:
    • BMS-986427
Experimental
Placebo 		Participants assigned to this arm will receive mavacamten (1 mg to 15 mg) from week 28 to end of treatment at week 200.
  • Drug: Placebo
    Specified dose on specified days

Recruiting Locations

The University of Alabama at Birmingham
Birmingham, Alabama 35294-0004
Contact:
Frank Pearce, Site 0017
205-934-3411

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Study Connect Contact Center www.BMSStudyConnect.com
855-907-3286
Clinical.Trials@bms.com