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
| Arm | Description | Assigned 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. |
|
|
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. |
|
Recruiting Locations
The University of Alabama at Birmingham
Birmingham, Alabama 35294-0004
Birmingham, Alabama 35294-0004
Contact:
Frank Pearce, Site 0017
205-934-3411
Frank Pearce, Site 0017
205-934-3411
More Details
- Status
- Recruiting
- Sponsor
- Bristol-Myers Squibb
Study Contact
BMS Study Connect Contact Center www.BMSStudyConnect.com855-907-3286
Clinical.Trials@bms.com