A Phase 2 Study of Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM)
NCT ID: NCT03442764
Last Updated: 2022-08-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
59 participants
INTERVENTIONAL
2018-03-30
2020-01-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group 1
Active Treatment for participants with base target trough concentration
mavacamten
MYK-461
Group 2
Active Treatment for participants with higher target trough concentration
mavacamten
MYK-461
Placebo
Placebo Group
Placebo
Placebo
Interventions
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mavacamten
MYK-461
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18 and greater, Body weight \> 45kg
* Documented LVEF ≥ 55% at the Screening as determined by echo central lab
* LVOT gradient \< 30 mmHg at rest AND during Valsalva AND post-exercise
* NYHA functional class II or III
* Elevated NT-proBNP at rest
Exclusion Criteria
* History of resuscitated sudden cardiac arrest at any time or known appropriate implantable cardioverter defibrillator (ICD) discharge within 6 months prior to Screening
* Current treatment with disopyramide or ranolazine (within 14 days prior to Screening)
* Current or planned treatment during the study with a combination of beta-blockers and calcium channel blockers
* Has been treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation \[ASA\]) within 6 months prior to Screening
* History of resting or post-exercise LVOT \>30 mmHg unless subsequently treated by septal reduction
* Has QTc Fridericia (QTcF) \>480 ms or any other ECG abnormality considered by the investigator to pose a risk to participant safety (eg, second-degree atrioventricular block type II)
* Has persistent or permanent atrial fibrillation not on anticoagulation for at least 4 weeks prior to Screening and/or not adequately rate-controlled within 1 year of Screening
* History of clinically significant malignant disease within 10 years such as non-metastatic cutaneous squamous cell or basal cell carcinoma
* History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or MyoKardia physician, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
18 Years
ALL
No
Sponsors
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MyoKardia, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Myokardia Medical Information Team
Role: STUDY_DIRECTOR
MyoKardia, Inc.
Locations
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Mayo Clinic Arizona
Scottsdale, Arizona, United States
Cedars-Sinai Medical Center (Smidt Heart Institute)
Los Angeles, California, United States
Stanford Hospital and Clinics/Stanford University
Palo Alto, California, United States
University of California, San Francisco
San Francisco, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Northwestern University
Evanston, Illinois, United States
St. Vincent Medical Group
Indianapolis, Indiana, United States
University of Iowa Hospitals and clinics
Iowa City, Iowa, United States
University of Maryland Medical System
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Michigan Medicine
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
NYU Winthrop Hospital
Mineola, New York, United States
NYU Langone Medical Center
New York, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Duke Cardiology at Southpoint
Durham, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
St. Luke's Cardiology Associates
Bethlehem, Pennsylvania, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
The University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Baylor St. Luke Medical Center at Houston, Texas Heart Institute Out-patient Clinic
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Utah Medical Center
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Unity Point Health Meriter Heart and Vascular Institute
Madison, Wisconsin, United States
Countries
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References
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Ho CY, Mealiffe ME, Bach RG, Bhattacharya M, Choudhury L, Edelberg JM, Hegde SM, Jacoby D, Lakdawala NK, Lester SJ, Ma Y, Marian AJ, Nagueh SF, Owens A, Rader F, Saberi S, Sehnert AJ, Sherrid MV, Solomon SD, Wang A, Wever-Pinzon O, Wong TC, Heitner SB. Evaluation of Mavacamten in Symptomatic Patients With Nonobstructive Hypertrophic Cardiomyopathy. J Am Coll Cardiol. 2020 Jun 2;75(21):2649-2660. doi: 10.1016/j.jacc.2020.03.064.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MYK-461-006
Identifier Type: -
Identifier Source: org_study_id
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