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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 February 2024 |
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Main ID: |
NCT03496168 |
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Date of registration:
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05/04/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER
PIONEER-OLE |
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Scientific title:
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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) |
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Date of first enrolment:
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April 26, 2018 |
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Target sample size:
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13 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03496168 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Bristol-Myers Squibb |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bristol-Myers Squibb |
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Key inclusion & exclusion criteria
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Key Inclusion Criteria:
- Completed Study MYK-461-004. Prior participation in a non-interventional observational
study is allowed.
- Body weight > 45 kg at Screening
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypertrophic Cardiomyopathy
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Intervention(s)
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Drug: mavacamten
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Primary Outcome(s)
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Frequency and severity of adverse events and serious adverse events.
[Time Frame: Up to 260 weeks]
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Secondary ID(s)
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CV027-008
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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