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



Status:Active, not recruiting
Conditions:High Cholesterol, Cardiology, Orthopedic
Therapuetic Areas:Cardiology / Vascular Diseases, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:3/8/2019
Start Date:April 26, 2018
End Date:March 2021

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An Open-Label Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in Study MYK-461-004 (PIONEER)

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).


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 > 480 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
We found this trial at
4
sites
6301 Herndon Road
Durham, North Carolina 27713
Principal Investigator: Andrew Wang, MD
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Durham, NC
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Stephen Heitner, MD
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Principal Investigator: Daniel Jacoby, MD
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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New Haven, CT
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Scottsdale, Arizona 85259
Principal Investigator: Steven Heitner, MD
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Scottsdale, AZ
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