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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT06253221
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Cardiomyopathy, Hypertrophic

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Mavacamten — DRUG
    Specified dose on specified days
  • Placebo — DRUG
    Specified dose on specified days

Study Details

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

Key Dates

Start date
Apr 17, 2024
Status verified
Dec 2025
Primary completion
Nov 25, 2025
Completion
Mar 28, 2031

Study Design

Enrollment
44 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change from baseline in Valsalva left ventricular outflow tract (LVOT) (VLVOT) gradient [ Time Frame: At Week 28 ]

Locations (31)

FacilityCityStateZIPSite coordinators
Local Institution - 0017BirminghamAlabama35294-0004-
Local Institution - 0050PhoenixArizona85016-7710-
Local Institution - 0008Los AngelesCalifornia90095-8344-
Local Institution - 0032Los AngelesCalifornia90027-6062-
Local Institution - 0033Palo AltoCalifornia94304-1601-
Local Institution - 0044San DiegoCalifornia92123-4223-
Local Institution - 0038AuroraColorado80045-7106-
Local Institution - 0031St. PetersburgFlorida33701-4634-
Local Institution - 0053AtlantaGeorgia30329-3117-
Local Institution - 0013ChicagoIllinois60637-1447-
Local Institution - 0009IndianapolisIndiana46202-5272-
Local Institution - 0043BostonMassachusetts02115-5724-
Local Institution - 0002Ann ArborMichigan48109-
Local Institution - 0037St LouisMissouri63110-
Local Institution - 0052MorristownNew Jersey07960-
Local Institution - 0010New Hyde ParkNew York11042-
Local Institution - 0024New YorkNew York10029-6574-
Local Institution - 0036New YorkNew York10032-1559-
Local Institution - 0040The BronxNew York10467-2403-
Local Institution - 0015CharlotteNorth Carolina28204-
Local Institution - 0039DurhamNorth Carolina27705-
Local Institution - 0019CincinnatiOhio45229-
Local Institution - 0001ClevelandOhio44195-0001-
Local Institution - 0029ColumbusOhio43205-
Local Institution - 0030PhiladelphiaPennsylvania19104-4319-
Local Institution - 0005PittsburghPennsylvania15224-1334-
Local Institution - 0034MemphisTennessee38105-
Local Institution - 0045AustinTexas78712-
Local Institution - 0054HoustonTexas77030-
Local Institution - 0003Salt Lake CityUtah84113-1103-
Local Institution - 0012CharlottesvilleVirginia22908-0816-

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By research site
Local Institution - 0017· Birmingham, ALLocal Institution - 0050· Phoenix, AZLocal Institution - 0008· Los Angeles, CALocal Institution - 0032· Los Angeles, CALocal Institution - 0033· Palo Alto, CALocal Institution - 0044· San Diego, CA

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