A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03723655
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

Approximately 30 sites that enrolled participants in the MAVERICK-HCM (MYK-461-006) study in the United States (US) will initiate this study. Approximately 90 sites that enrolled participants in the EXPLORER-HCM (MYK-461-005) study in the US, Europe, and Israel will initiate this study. Note: Approximately 30 centers overlap between MAVERICK and EXPLORER.

Key Dates

Start date
Sep 27, 2018
Status verified
Feb 2026
Primary completion
Jan 16, 2026
Completion
Jan 16, 2026

Study Design

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

Arms

  • Experimental: Group 1
    Active Treatment for participants with base target trough concentration
  • Experimental: Group 2
    Active Treatment for participants with higher target trough concentration
  • Experimental: Group 3
    Active Treatment for participants dose titrated to clinical response

Primary Outcome Measure

Frequency and severity of treatment-emergent adverse events and serious adverse events [ Time Frame: 252 weeks ]

Locations (31)

FacilityCityStateZIPSite coordinators
Local Institution - 0045ScottsdaleArizona85259-
Local Institution - 0058Los AngelesCalifornia90027-
Local Institution - 0066San FranciscoCalifornia94143-
Local Institution - 0063StanfordCalifornia94305-
Local Institution - 0043New HavenConnecticut06520-8017-
Local Institution - 0067JacksonvilleFlorida32224-
Local Institution - 0050ChicagoIllinois60611-
Local Institution - 0070IndianapolisIndiana46260-
Local Institution - 0049Iowa CityIowa52242-
Local Institution - 0054BostonMassachusetts02115-
Local Institution - 0051Ann ArborMichigan48109-
Local Institution - 0074Grand RapidsMichigan49503-
Local Institution - 0048St LouisMissouri63110-
Local Institution - 0056New YorkNew York10032-
Local Institution - 0060New YorkNew York10016-
Local Institution - 0071CharlotteNorth Carolina28204-
Local Institution - 0047DurhamNorth Carolina27710-
Local Institution - 0052CincinnatiOhio45267-
Local Institution - 0044PortlandOregon97239-
Local Institution - 0068BethlehemPennsylvania18015-
Local Institution - 0046PhiladelphiaPennsylvania19104-
Local Institution - 0064PittsburghPennsylvania15213-
Local Institution - 0073MemphisTennessee38104-
Local Institution - 0061DallasTexas75390-
Local Institution - 0055HoustonTexas77030-
Local Institution - 0057HoustonTexas77030-
Local Institution - 0072MurrayUtah84107-5701-
Local Institution - 0062Salt Lake CityUtah84112-
Local Institution - 0053CharlottesvilleVirginia22903-
Local Institution - 0059RichmondVirginia23298-
Local Institution - 0065SeattleWashington98195-

Find similar trials in Scottsdale, AZ

By research site
Local Institution - 0045· Scottsdale, AZLocal Institution - 0058· Los Angeles, CALocal Institution - 0066· San Francisco, CALocal Institution - 0063· Stanford, CALocal Institution - 0043· New Haven, CTLocal Institution - 0067· Jacksonville, FL

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