Trials / Completed
CompletedNCT03723655
A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM
A Long-Term Safety Extension Study of Mavacamten (MYK-461) in Adults With Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 314 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Approximately 30 sites that enrolled participants in the MAVERICK-HCM (MYK-461-006) study in the United States (US) will initiate this study. Approximately 90 sites that enrolled participants in the EXPLORER-HCM (MYK-461-005) study in the US, Europe, and Israel will initiate this study. Note: Approximately 30 centers overlap between MAVERICK and EXPLORER.
Conditions
- Hypertrophic Cardiomyopathy
- Obstructive Hypertrophic Cardiomyopathy
- Non-obstructive Hypertrophic Cardiomyopathy
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | mavacamten | mavacamten capsules |
Timeline
- Start date
- 2018-09-27
- Primary completion
- 2026-01-16
- Completion
- 2026-01-16
- First posted
- 2018-10-29
- Last updated
- 2026-02-20
Locations
68 sites across 13 countries: United States, Belgium, Czechia, Denmark, France, Germany, Israel, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03723655. Inclusion in this directory is not an endorsement.