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NCT00848939 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of Oral Treprostinil in Patients With Systemic Sclerosis
A Phase 1 study, sponsored by United Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT00848939: Completed Phase 1 study, sponsored by United Therapeutics.
NCT00848939 is a Phase 1 study that has completed, run by United Therapeutics. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00848939, a Phase 1 study, has completed, sponsored by United Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
This study will assess the pharmacokinetic and safety profile of treprostinil following fixed and escalating doses of treprostinil diethanolamine SR tablets. Open-label, two-part study assessing the pharmacokinetics, safety, and tolerability of oral treprostinil diethanolamine SR. Cohort 1: single 1 mg treprostinil diethanolamine SR dose. Cohort 2: escalating doses of treprostinil diethanolamine SR up to a target dose of 4 mg BID.
Interventions
- DRUG treprostinil diethanolamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2008-12 |
| Est. Completion | 2010-04 |
| Phase | Phase 1 |
What the finished NCT00848939 record still lists
NCT00848939 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which treprostinil diethanolamine is the first listed.
NCT00848939 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00848939 about?
NCT00848939 is a clinical study titled "Pharmacokinetics of Oral Treprostinil in Patients With Systemic Sclerosis". This study will assess the pharmacokinetic and safety profile of treprostinil following fixed and escalating doses of treprostinil diethanolamine SR tablets. Open-label, two-part study assessing the pharmacokinetics, safety, and tolerability of oral treprostinil diethanolamine SR. Cohort 1: single 1...
What is the current status of trial NCT00848939?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2008-12. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00848939?
The interventions under investigation include: treprostinil diethanolamine (DRUG).
Who is sponsoring clinical trial NCT00848939?
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 NCT00848939's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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