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NCT02310672 · ClinicalTrials.gov registry record · Phase 4
REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension
A Phase 4 study, sponsored by Actelion.
- Completed
- Registry status
- Phase 4
- Development phase
- 89
- Enrollment target
NCT02310672: Completed Phase 4 study, sponsored by Actelion.
NCT02310672 is a Phase 4 study that has completed, run by Actelion. The registered enrollment target is 89 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02310672, a Phase 4 study, has completed, sponsored by Actelion.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 89 participants
- Enrollment target
Study Summary
The study evaluates the effect of macitentan on right ventricular and hemodynamic properties in patients with symptomatic pulmonary arterial hypertension. Patients are treated with macitentan for 1 year. Patients undergo right heart catheterization (RHC) at baseline and Week 26. They also undergo cardiac magnetic resonance imaging (MRI) at baseline, Week 26 and Week 52. Safety is monitored throughout the study. The study has three stub-studies. Each patient can participate in no sub-study or in one sub-study. The sub-studies are: (1) metabolism sub-study (with PET-MR scans); (2) biopsy sub-study (biopsies taken during the RHC); (3) Echo sub-study.
Primary Outcome
Change from baseline in RVSV assessed by cardiac magnetic resonance imaging (MRI) from pulmonary artery flow was reported at Week 26. Primary analysis were based on interim results as pre-planned and the primary outcome measures data table reported is finalized as is.
Interventions
- DRUG Macitentan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2015-06-01 |
| Est. Completion | 2019-09-10 |
| Phase | Phase 4 |
What the finished NCT02310672 record still lists
NCT02310672 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Macitentan is the first listed.
NCT02310672 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02310672 about?
NCT02310672 is a clinical study titled "REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension". The study evaluates the effect of macitentan on right ventricular and hemodynamic properties in patients with symptomatic pulmonary arterial hypertension. Patients are treated with macitentan for 1 year. Patients undergo right heart catheterization (RHC) at baseline and Week 26. They also undergo ca...
What is the current status of trial NCT02310672?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 89 participants. The study started on 2015-06-01. Estimated completion is 2019-09-10.
What interventions are being tested in trial NCT02310672?
The interventions under investigation include: Macitentan (DRUG).
Who is sponsoring clinical trial NCT02310672?
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 NCT02310672's enrollment target sits among peer trials
89 913th of 2000 higher than 1,085 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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