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NCT02583789 · ClinicalTrials.gov registry record · Early Phase 1
Assess Efficacy of of Oral Treprostinil in Patients With Symptomatic Primary or Secondary Raynaud's Phenomenon
A Early Phase 1 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
NCT02583789: Completed Early Phase 1 study, sponsored by Brigham and Women's Hospital.
NCT02583789 is a Early Phase 1 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 12 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02583789, a Early Phase 1 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This study represents the first trial to assess the efficacy of oral treprostinil therapy in patients with symptomatic primary or secondary Raynaud's Phenomenon (RP) resistant to vasodilatory therapy. The study will be randomized 1:1 UT-15C to placebo. The design is a crossover study and all subjects will be randomized to receive oral treprostinil sustained release tablets or matching placebo for 12 weeks and then crossover for 12 weeks. All subjects will be exposed for 12 weeks of treatment with oral UT-15C during the study.
Primary Outcome
Change in the Raynaud's Condition Score from baseline (2-week run in), comparing treprostinil treatment phase vs. placebo phase
Interventions
- DRUG Placebo
- DRUG oral treprostinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2016-05 |
| Est. Completion | 2021-12-31 |
| Phase | Early Phase 1 |
What the finished NCT02583789 record still lists
NCT02583789 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02583789 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02583789 about?
NCT02583789 is a clinical study titled "Assess Efficacy of of Oral Treprostinil in Patients With Symptomatic Primary or Secondary Raynaud's Phenomenon". This study represents the first trial to assess the efficacy of oral treprostinil therapy in patients with symptomatic primary or secondary Raynaud's Phenomenon (RP) resistant to vasodilatory therapy. The study will be randomized 1:1 UT-15C to placebo. The design is a crossover study and all subjec...
What is the current status of trial NCT02583789?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2016-05. Estimated completion is 2021-12-31.
What interventions are being tested in trial NCT02583789?
The interventions under investigation include: Placebo (DRUG), oral treprostinil (DRUG).
Who is sponsoring clinical trial NCT02583789?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02583789's enrollment target sits among peer trials
12 1530th of 2000 higher than 401 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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