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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 is a Phase 2 study that has completed, run by United Therapeutics. The registered enrollment target is 148 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00775463
The ClinicalTrials.gov registry entry for NCT00775463 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 148 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United Therapeutics, which has 63 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00775463 reports 0 study locations.
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.
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