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NCT01106014 · ClinicalTrials.gov registry record · Phase 3
Selexipag (ACT-293987) in Pulmonary Arterial Hypertension
A Phase 3 study, sponsored by Actelion.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,156
- Enrollment target
NCT01106014: Completed Phase 3 study, sponsored by Actelion.
NCT01106014 is a Phase 3 study that has completed, run by Actelion. The registered enrollment target is 1,156 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01106014, a Phase 3 study, has completed, sponsored by Actelion.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,156 participants
- Enrollment target
Study Summary
The AC-065A302 (GRIPHON) study is an event-driven Phase 3 study to demonstrate the effect of selexipag on time to first morbidity or mortality event in patients with pulmonary arterial hypertension.
Primary Outcome
Time from randomization to the first occurrence of a morbidity event or death (all causes) was analyzed with the Kaplan-Meier method (event-free KM estimates at different time points). Morbidity event was defined as any of the following events confirmed by the Critical Event committee: * Hospitalization for worsening of pulmonary arterial hypertension (PAH), * Worsening of PAH resulting in need for lung transplantation or balloon atrial septostomy, * Initiation of parenteral prostanoid therapy
Interventions
- DRUG Placebo
- DRUG Selexipag
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,156 participants |
| Start Date | 2009-12-01 |
| Est. Completion | 2014-10-01 |
| Phase | Phase 3 |
What the finished NCT01106014 record still lists
NCT01106014 is an interventional study that assigns participants to a tested intervention. Its 1,156 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01106014 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01106014 about?
NCT01106014 is a clinical study titled "Selexipag (ACT-293987) in Pulmonary Arterial Hypertension". The AC-065A302 (GRIPHON) study is an event-driven Phase 3 study to demonstrate the effect of selexipag on time to first morbidity or mortality event in patients with pulmonary arterial hypertension.
What is the current status of trial NCT01106014?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,156 participants. The study started on 2009-12-01. Estimated completion is 2014-10-01.
What interventions are being tested in trial NCT01106014?
The interventions under investigation include: Placebo (DRUG), Selexipag (DRUG).
Who is sponsoring clinical trial NCT01106014?
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 NCT01106014's enrollment target sits among peer trials
1,156 238th of 2000 higher than 1,763 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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