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NCT01112306 · ClinicalTrials.gov registry record · Phase 3
ACT-293987 in Pulmonary Arterial Hypertension
A Phase 3 study, sponsored by Actelion.
- Completed
- Registry status
- Phase 3
- Development phase
- 709
- Enrollment target
NCT01112306: Completed Phase 3 study, sponsored by Actelion.
NCT01112306 is a Phase 3 study that has completed, run by Actelion. The registered enrollment target is 709 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
NCT01112306, a Phase 3 study, has completed, sponsored by Actelion.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 709 participants
- Enrollment target
Study Summary
Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the safety and tolerability of ACT-293987 in patients with PAH who participated in the double-blind study AC-065A302 (GRIPHON)
Primary Outcome
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A TEAE is any AE temporally associated with the use of study drug (from study drug initiation until 3 days after study drug discontinuation), whether or not considered related to the study drug.
Interventions
- DRUG ACT-293987
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 709 participants |
| Start Date | 2010-07-07 |
| Est. Completion | 2021-08-26 |
| Phase | Phase 3 |
What the finished NCT01112306 record still lists
NCT01112306 is an interventional study that assigns participants to a tested intervention. The registered 709 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 1 intervention - of which ACT-293987 is the first listed.
NCT01112306 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01112306 about?
NCT01112306 is a clinical study titled "ACT-293987 in Pulmonary Arterial Hypertension". Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the safety and tolerability of ACT-293987 in patients with PAH who participated in the double-blind study AC-065A302 (GRIPHON)
What is the current status of trial NCT01112306?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 709 participants. The study started on 2010-07-07. Estimated completion is 2021-08-26.
What interventions are being tested in trial NCT01112306?
The interventions under investigation include: ACT-293987 (DRUG).
Who is sponsoring clinical trial NCT01112306?
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 NCT01112306's enrollment target sits among peer trials
709 505th of 2000 higher than 1,496 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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