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NCT00775463 · ClinicalTrials.gov registry record · Phase 2
Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine
A Phase 2 study, sponsored by United Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 148
- Enrollment target
NCT00775463: Completed Phase 2 study, sponsored by United Therapeutics.
NCT00775463 is a Phase 2 study that has completed, run by United Therapeutics. The registered enrollment target is 148 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00775463, a Phase 2 study, has completed, sponsored by United Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 148 participants
- Enrollment target
Study Summary
This study will evaluate the effect of treprostinil diethanolamine (UT-15C) sustained release tablets(compared to placebo) on digital ulcers in patients with scleroderma. Treprostinil diethanolamine is an analog of prostacyclin. Prostacyclin is a naturally occuring substance produced by the cells of blood vessels that inhibits platelet aggregation, induces vasodilation, and suppresses smooth muscle proliferation. Improvement in blood flow in lower limbs and fingers would be anticipated to result in a reduction in ischemic pain, Raynaud's phenomenon and promote healing of digital ulcers and other ischemic wounds.
Primary Outcome
Net ulcer burden was defined as the number of "new" or "active" digital ulcers (DU), plus the number of "indeterminate" DUs at that assessment that have previously been classified as either "active" or "new" at any earlier assessment during the study. A DU was defined as an area with visually discernable depth and a loss of continuity of epithelial coverage, which could be denuded or covered by a scab or necrotic tissue. If denuded, the DU was pronounced "active." If denudation could not be judg
Interventions
- DRUG placebo
- DRUG treprostinil diethanolamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2009-05 |
| Est. Completion | 2011-07 |
| Phase | Phase 2 |
What the finished NCT00775463 record still lists
NCT00775463 is an interventional study that assigns participants to a tested intervention. The registered 148 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00775463 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00775463 about?
NCT00775463 is a clinical study titled "Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine". This study will evaluate the effect of treprostinil diethanolamine (UT-15C) sustained release tablets(compared to placebo) on digital ulcers in patients with scleroderma. Treprostinil diethanolamine is an analog of prostacyclin. Prostacyclin is a naturally occuring substance produced by the cells of...
What is the current status of trial NCT00775463?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 148 participants. The study started on 2009-05. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00775463?
The interventions under investigation include: placebo (DRUG), treprostinil diethanolamine (DRUG).
Who is sponsoring clinical trial NCT00775463?
This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00775463's enrollment target sits among peer trials
148 491st of 2000 higher than 1,506 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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