A Phase 2 Study of Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM)

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
MyoKardia, Inc.
Study ID
NCT03442764
Phase
PHASE2
Status
Completed

Conditions

  • Non-obstructive Hypertrophic Cardiomyopathy

Eligibility Criteria

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

Interventions

Study Details

This is a multicenter, exploratory, randomized, double-blind study of the administration of mavacamten in 60 participants with symptomatic nHCM randomized to receive a 16-week course of mavacamten doses titrated to achieve 1 of 2 target drug concentrations.

Key Dates

Start date
Mar 30, 2018
Status verified
Jul 2022
Primary completion
Jan 7, 2020
Completion
Jan 7, 2020

Study Design

Enrollment
59 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
  • Placebo Comparator: Placebo
    Placebo Group

Primary Outcome Measure

Percentage of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE) [ Time Frame: From first dose to 8 weeks following last dose (Up to 24 weeks) ]

Locations (32)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaScottsdaleArizona85259-
Cedars-Sinai Medical Center (Smidt Heart Institute)Los AngelesCalifornia90048-
Stanford Hospital and Clinics/Stanford UniversityPalo AltoCalifornia94305-
University of California, San FranciscoSan FranciscoCalifornia94143-
Yale New Haven HospitalNew HavenConnecticut06520-
Northwestern UniversityEvanstonIllinois60208-
St. Vincent Medical GroupIndianapolisIndiana46260-
University of Iowa Hospitals and clinicsIowa CityIowa52242-
University of Maryland Medical SystemBaltimoreMaryland21201-
Brigham and Women's HospitalBostonMassachusetts02115-
Michigan MedicineAnn ArborMichigan48109-
Henry Ford HospitalDetroitMichigan48202-
Washington University School of MedicineSt LouisMissouri63110-
NYU Winthrop HospitalMineolaNew York11501-
NYU Langone Medical CenterNew YorkNew York10016-
Carolinas Medical CenterCharlotteNorth Carolina28203-
Duke Cardiology at SouthpointDurhamNorth Carolina27713-
University of Cincinnati Medical CenterCincinnatiOhio45219-
Oregon Health and Science UniversityPortlandOregon97239-
St. Luke's Cardiology AssociatesBethlehemPennsylvania18018-
Penn State Health Milton S. Hershey Medical CenterHersheyPennsylvania17033-0850-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
UPMC PresbyterianPittsburghPennsylvania15213-
The University of Texas Southwestern Medical Center at DallasDallasTexas75390-9034-
Baylor St. Luke Medical Center at Houston, Texas Heart Institute Out-patient ClinicHoustonTexas77030-
Houston Methodist HospitalHoustonTexas77030-
Intermountain Medical CenterMurrayUtah84107-
University of Utah Medical CenterSalt Lake CityUtah84132-
University of VirginiaCharlottesvilleVirginia22908-
Virginia Commonwealth UniversityRichmondVirginia23298-
University of Washington Medical CenterSeattleWashington98195-
Unity Point Health Meriter Heart and Vascular InstituteMadisonWisconsin53713-

Find similar trials in Scottsdale, AZ

By research site
Mayo Clinic Arizona· Scottsdale, AZCedars-Sinai Medical Center (Smidt Heart Institute)· Los Angeles, CAStanford Hospital and Clinics/Stanford University· Palo Alto, CAUniversity of California, San Francisco· San Francisco, CAYale New Haven Hospital· New Haven, CTNorthwestern University· Evanston, IL

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