Trials / Completed
CompletedNCT02126943
OPsumit USers Registry
US-based, Observational, Drug Registry of Opsumit® (Macitentan) New Users in Clinical Practice
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,686 (actual)
- Sponsor
- Actelion · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Prospective observational drug registry developed to characterize the safety profile (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Opsumit (macitentan) | 10 mg tablets |
Timeline
- Start date
- 2014-04-30
- Primary completion
- 2020-04-24
- Completion
- 2020-04-24
- First posted
- 2014-04-30
- Last updated
- 2025-03-30
Locations
146 sites across 2 countries: United States, Puerto Rico
Source: ClinicalTrials.gov record NCT02126943. Inclusion in this directory is not an endorsement.