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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: Completed Phase 3 study, sponsored by Actelion.
NCT00660179 is a Phase 3 study that has completed, run by Actelion. The registered enrollment target is 742 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Morbidity or mortality events were defined as: a) Death; b) Atrial septostomy; c) Lung transplantation; d) Initiation of intravenous (i.v.) or subcutaneous prostanoids, or; e) Other worsening of pulmonary arterial hypertension (PAH). Other worsening of PAH was defined by the combined occurrence of all the following 3 events: At least 15% decrease in the 6 minute walk distance from baseline, confirmed by 2 tests performed on separate days, within 2 weeks. AND worsening of PAH symptoms includin
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 |
What the finished NCT00660179 record still lists
NCT00660179 is an interventional study that assigns participants to a tested intervention. The registered 742 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00660179 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00660179's enrollment target sits among peer trials
742 476th of 2000 higher than 1,525 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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