Trials / Completed
CompletedNCT03197688
Retrospective Chart Review of First-time Opsumit® (Macitentan) Users in the United States
Multicenter, Retrospective Chart Review of First-time Opsumit® (Macitentan) Users in the United States
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,200 (actual)
- Sponsor
- Actelion · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The Opsumit Users registry (OPUS; NCT02126943) was developed to characterize the safety profile of Opsumit and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting. It is expected that the recruitment target of the OPUS registry cannot be achieved within the planned time period (5000 Opsumit new users by October 2018). The OrPHeUS study is designed to supplement the OPUS registry with retrospectively identified first-time Opsumit users in order to achieve the desired sample size.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Notapplicable | Not applicable as non-interventional study |
Timeline
- Start date
- 2017-08-03
- Primary completion
- 2018-09-06
- Completion
- 2018-09-06
- First posted
- 2017-06-23
- Last updated
- 2025-03-30
Locations
106 sites across 2 countries: United States, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03197688. Inclusion in this directory is not an endorsement.