Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
MyoKardia, Inc.
Study ID
NCT03470545
Phase
PHASE3
Status
Completed

Conditions

  • Obstructive Hypertrophic Cardiomyopathy

Eligibility Criteria

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

Interventions

  • mavacamten — DRUG
    mavacamten capsules
  • Placebo — DRUG
    placebo oral capsule

Study Details

This is a multicenter, international, double-blind study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM). Approximately 220 participants will be randomized to receive placebo or mavacamten.

Key Dates

Start date
May 29, 2018
Status verified
May 2020
Primary completion
Mar 14, 2020
Completion
May 6, 2020

Study Design

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

Arms

  • Experimental: mavacamten (MYK-461)
  • Placebo Comparator: Placebo

Primary Outcome Measure

Percentage of Participants Achieving A Clinical Response [ Time Frame: 30 weeks ]

Locations (29)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaScottsdaleArizona85259-
Cedars-Sinai Medical Center (Smidt Heart Institute)Los AngelesCalifornia90048-
UCSF School of MedicineSan FranciscoCalifornia94143-
Stanford UniversityStanfordCalifornia94305-
Yale New Haven HospitalNew HavenConnecticut16511-
Mayo Clinic Jacksonville - PPDSJacksonvilleFlorida32224-
Northwestern UniversityChicagoIllinois60611-
University Of Iowa Hospitals And ClinicsIowa CityIowa52242-
Brigham and Women's HospitalBostonMassachusetts02115-
University of MichiganAnn ArborMichigan48109-
Spectrum HealthGrand RapidsMichigan49512-
Washington University School of MedicineSt LouisMissouri63110-
Columbia University Medical CenterNew YorkNew York10032-
NYU Langone Medical CenterNew YorkNew York10017-
Carolinas Medical CenterCharlotteNorth Carolina28203-
Duke Cardiology at SouthpointDurhamNorth Carolina27710-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Oregon Health & Science UniversityPortlandOregon97239-
St. Luke's Cardiology AssociatesBethlehemPennsylvania18018-
University of Pennsylvania (Penn Heart and Vascular Center)PhiladelphiaPennsylvania19104-
University of Pittsburgh Medical Center PresbyterianPittsburghPennsylvania15213-
Methodist University HospitalMemphisTennessee38163-
University of Texas Southwestern Medical CenterDallasTexas75235-
Houston Methodist HospitalHoustonTexas77030-
University of Texas Houston Medical SchoolHoustonTexas77030-
Intermountain Medical CenterSalt Lake CityUtah84107-
University of UtahSalt Lake CityUtah84132-
University of Virginia Health SystemCharlottesvilleVirginia22903-
University of Washington Medical CenterSeattleWashington98195-

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