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Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER (PIONEER-OLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03496168
Recruitment Status : Active, not recruiting
First Posted : April 12, 2018
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
MyoKardia, Inc.

Brief Summary:
This is a multicenter open-label study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM) who previously participated in study MYK-461-004 (PIONEER-HCM).

Condition or disease Intervention/treatment Phase
Hypertrophic Cardiomyopathy Drug: mavacamten Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in Study MYK-461-004 (PIONEER)
Actual Study Start Date : April 26, 2018
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : March 2022


Arm Intervention/treatment
Experimental: mavacamten (MYK-461) Drug: mavacamten
mavacamten capsules
Other Name: MYK-461




Primary Outcome Measures :
  1. Frequency and severity of adverse events and serious adverse events. [ Time Frame: Up to 120 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Completed Study MYK-461-004
  • Body weight > 45 kg
  • Has safety laboratory parameters (chemistry and hematology) within normal limits

Key Exclusion Criteria:

  • Has QTcF > > 500 ms or any other ECG abnormality considered by the investigator to pose a risk to subject safety (eg, second degree atrioventricular block type II)
  • Since enrollment into Study MYK-461-004, has developed obstructive coronary artery disease (> 70% stenosis in one or more arteries) or known moderate or severe aortic valve stenosis
  • Since enrollment into Study MYK-461-004, has developed any acute or serious comorbid condition (eg, major infection or hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction) that, in the opinion of the investigator or medical monitor, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
  • Since enrollment into Study MYK-461-004 has developed clinically significant malignant disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496168


Locations
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United States, Arizona
Mayo Clinic Arizona, Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States, 06511
United States, North Carolina
Duke Cardiology at Southpoint
Durham, North Carolina, United States, 27713
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
MyoKardia, Inc.
Investigators
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Study Director: MyoKardia Medical Information Team MyoKardia, Inc.
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Responsible Party: MyoKardia, Inc.
ClinicalTrials.gov Identifier: NCT03496168    
Other Study ID Numbers: MYK-461-008
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MyoKardia, Inc.:
Symptomatic
Obstructive
Left ventricular outflow tract gradient
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases