A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT05582395
Phase
PHASE3
Status
Completed

Conditions

  • Cardiomyopathy, Hypertrophic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

The purpose of this study is to evaluate the safety, tolerability, and efficacy of mavacamten compared with placebo in participants with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).

Key Dates

Start date
Dec 14, 2022
Status verified
Nov 2025
Primary completion
Mar 6, 2025
Completion
Oct 20, 2025

Study Design

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

Arms

  • Experimental: Mavacamten
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change from baseline in Kansas City Cardiomyopathy Questionnaire (23-item) Clinical Summary Score (KCCQ-23 CSS) at Week 48 [ Time Frame: Up to Week 48 ]

Locations (41)

FacilityCityStateZIPSite coordinators
Local Institution - 0082BirminghamAlabama35233-1900-
Local Institution - 0458PhoenixArizona85054-
Local Institution - 0409La JollaCalifornia92037-1337-
Local Institution - 0010Los AngelesCalifornia90048-3311-
Local Institution - 0406San FranciscoCalifornia94143-2204-
Local Institution - 0079StanfordCalifornia94305-2200-
Local Institution - 0468GainesvilleFlorida32608-1134-
Local Institution - 0281TampaFlorida33606-3603-
Local Institution - 0092AtlantaGeorgia30322-
Local Institution - 0424IndianapolisIndiana46202-1243-
Local Institution - 0070Iowa CityIowa52242-1009-
Local Institution - 0410Kansas CityKansas66160-8500-
Local Institution - 0484LouisvilleKentucky40217-1363-
Local Institution - 0127BaltimoreMaryland21287-
Local Institution - 0479BostonMassachusetts02114-
Local Institution - 0500BostonMassachusetts02118-2908-
Local Institution - 0464Ann ArborMichigan48109-
Local Institution - 0064DetroitMichigan48202-2608-
Local Institution - 0455Grand RapidsMichigan49525-
Local Institution - 0431RochesterMinnesota55905-
Local Institution - 0461St LouisMissouri63110-
Local Institution - 0435OmahaNebraska68198-2265-
Local Institution - 0490MorristownNew Jersey07962-
Local Institution - 0449ManhassetNew York11030-3816-
Local Institution - 0486New YorkNew York10019-1147-
Local Institution - 0007Stony BrookNew York11790-3407-
Local Institution - 0426ValhallaNew York10595-
Local Institution - 0094CharlotteNorth Carolina28204-2826-
Local Institution - 0065DurhamNorth Carolina27710-
Local Institution - 0083ClevelandOhio44195-
Local Institution - 0047HersheyPennsylvania17033-
Local Institution - 0444LancasterPennsylvania17602-2250-
Local Institution - 0263PhiladelphiaPennsylvania19104-
Local Institution - 0081PittsburghPennsylvania15213-2536-
Local Institution - 0207GermantownTennessee38138-1727-
Local Institution - 0089DallasTexas75246-
Local Institution - 0365DallasTexas75390-
Local Institution - 0492PlanoTexas75093-
Local Institution - 0402Salt Lake CityUtah84132-0001-
Local Institution - 0478CharlottesvilleVirginia22908-0001-
Local Institution - 0095RichmondVirginia23298-5024-

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By research site
Local Institution - 0082· Birmingham, ALLocal Institution - 0458· Phoenix, AZLocal Institution - 0409· La Jolla, CALocal Institution - 0010· Los Angeles, CALocal Institution - 0406· San Francisco, CALocal Institution - 0079· Stanford, CA

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