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NCT00667823 · ClinicalTrials.gov registry record · Phase 3
Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension
A Phase 3 study, sponsored by Actelion.
- Completed
- Registry status
- Phase 3
- Development phase
- 550
- Enrollment target
NCT00667823: Completed Phase 3 study, sponsored by Actelion.
NCT00667823 is a Phase 3 study that has completed, run by Actelion. The registered enrollment target is 550 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00667823, a Phase 3 study, has completed, sponsored by Actelion.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 550 participants
- Enrollment target
Study Summary
The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055 302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic PAH.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAE are defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline.
Interventions
- DRUG Macitentan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 550 participants |
| Start Date | 2008-10-17 |
| Est. Completion | 2020-12-07 |
| Phase | Phase 3 |
What the finished NCT00667823 record still lists
NCT00667823 is an interventional study that assigns participants to a tested intervention. The registered 550 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% lower).
The record links to 0 conditions, and to 1 intervention - of which Macitentan is the first listed.
NCT00667823 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00667823 about?
NCT00667823 is a clinical study titled "Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension". The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055 302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic PAH.
What is the current status of trial NCT00667823?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 550 participants. The study started on 2008-10-17. Estimated completion is 2020-12-07.
What interventions are being tested in trial NCT00667823?
The interventions under investigation include: Macitentan (DRUG).
Who is sponsoring clinical trial NCT00667823?
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 NCT00667823's enrollment target sits among peer trials
550 680th of 2000 higher than 1,312 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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