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NCT03197688 · ClinicalTrials.gov registry record
Retrospective Chart Review of First-time Opsumit® (Macitentan) Users in the United States
A clinical trial, sponsored by Actelion.
- Completed
- Registry status
- 2,200
- Enrollment target
NCT03197688: Completed study, sponsored by Actelion.
NCT03197688 is a clinical trial that has completed, run by Actelion. The registered enrollment target is 2,200 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03197688 has completed, sponsored by Actelion.
- COMPLETED
- Registry status
- 2,200 participants
- Enrollment target
Study 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.
Primary Outcome
Incidence rates of liver test abnormalities, Occurrence of Hepatic Adverse Events (HAEs), Occurrence of any other Adverse Event (AE), Occurrence and reason for discontinuation of Opsumit treatment, hospitalization and death
Interventions
- OTHER Notapplicable
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,200 participants |
| Start Date | 2017-08-03 |
| Est. Completion | 2018-09-06 |
What the finished NCT03197688 record still lists
NCT03197688 is an observational study that tracks outcomes without assigning an intervention. Its 2,200 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which Notapplicable is the first listed.
NCT03197688 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03197688 about?
NCT03197688 is a clinical study titled "Retrospective Chart Review of First-time Opsumit® (Macitentan) Users in the United States". 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 canno...
What is the current status of trial NCT03197688?
This trial is currently completed. The enrollment target is 2,200 participants. The study started on 2017-08-03. Estimated completion is 2018-09-06.
What interventions are being tested in trial NCT03197688?
The interventions under investigation include: Notapplicable (OTHER).
Who is sponsoring clinical trial NCT03197688?
This trial is sponsored by Actelion, which has 63 total clinical trials registered on ClinicalTrials.gov.
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