NCT03496168CompletedPhase 2
Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER
An Open-Label Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in Study MYK-461-004 (PIONEER)
Source: ClinicalTrials.gov · Last updated 9 Jan 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 13 (actual)
- First submitted
- 5 Apr 2018
- Start date
- 26 Apr 2018
- Primary completion date
- 9 Nov 2023
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Hypertrophic cardiomyopathy
- NCT number
- NCT03496168
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 13
- From 26 Apr 2018 to the primary completion date, 9 Nov 2023
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution - 0004 Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Local Institution - 0001 Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Local Institution - 0002 Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Local Institution - 0003 Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.