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NCT00660179 · ClinicalTrials.gov registry record · Phase 3
Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension
A Phase 3 study, sponsored by Actelion.
- Completed
- Registry status
- Phase 3
- Development phase
- 742
- Enrollment target
NCT00660179 is a Phase 3 study that has completed, run by Actelion. The registered enrollment target is 742 participants.
The verdict
NCT00660179, a Phase 3 study, has completed, sponsored by Actelion.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 742 participants
- Enrollment target
Study Summary
The AC-055-302/SERAPHIN study will be an event-driven Phase III study, comparing two different doses of macitentan (ACT-064992) (3 and 10 mg) vs placebo in patients with symptomatic PAH. The main study objective is to demonstrate that macitentan (ACT-064992) prolongs time to the first morbidity or mortality event, and to evaluate the benefit/risk profile of macitentan (ACT-064992) in the treatment of patients with symptomatic PAH.
Interventions
- DRUG placebo
- DRUG macitentan (ACT-064992)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 742 participants |
| Start Date | 2008-05 |
| Est. Completion | 2012-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00660179
The ClinicalTrials.gov registry entry for NCT00660179 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 742 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actelion, which has 63 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00660179 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00660179 about?
NCT00660179 is a clinical study titled "Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension". The AC-055-302/SERAPHIN study will be an event-driven Phase III study, comparing two different doses of macitentan (ACT-064992) (3 and 10 mg) vs placebo in patients with symptomatic PAH. The main study objective is to demonstrate that macitentan (ACT-064992) prolongs time to the first morbidity or m...
What is the current status of trial NCT00660179?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 742 participants. The study started on 2008-05. Estimated completion is 2012-04.
What interventions are being tested in trial NCT00660179?
The interventions under investigation include: placebo (DRUG), macitentan (ACT-064992) (DRUG).
Who is sponsoring clinical trial NCT00660179?
This trial is sponsored by Actelion, which has 63 total clinical trials registered on ClinicalTrials.gov.
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