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NCT01027949 · ClinicalTrials.gov registry record · Phase 3
An Open-Label Extension Trial of UT-15C Sustained-release (SR) in Subjects With Pulmonary Arterial Hypertension
A Phase 3 study, sponsored by United Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 894
- Enrollment target
NCT01027949: Completed Phase 3 study, sponsored by United Therapeutics.
NCT01027949 is a Phase 3 study that has completed, run by United Therapeutics. The registered enrollment target is 894 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01027949, a Phase 3 study, has completed, sponsored by United Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 894 participants
- Enrollment target
Study Summary
This study provided/continued to provide oral treprostinil (UT-15C SR; treprostinil diethanolamine) to eligible subjects who participated in Studies TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, and TDE-PH-308. The study assessed the long term safety of oral treprostinil and the effect of continued treatment with oral treprostinil on exercise capacity after 1 year of treatment.
Primary Outcome
Assess the effect of continued therapy with oral treprostinil on exercise capacity as assessed by the change from Baseline in 6-Minute Walk Test (6MWT) after 1 year of treatment. The 6MWT is the clinical standard for assessing subject functional status in the treatment of PAH and has been considered an objective measure of subject functional status by the American Thoracic Society. The distance a subject can walk in 6 minutes is recorded in meters.
Interventions
- DRUG Oral Treprostinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 894 participants |
| Start Date | 2007-01-16 |
| Est. Completion | 2020-02-12 |
| Phase | Phase 3 |
What the finished NCT01027949 record still lists
NCT01027949 is an interventional study that assigns participants to a tested intervention. The registered 894 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% higher).
The record links to 0 conditions, and to 1 intervention - of which Oral Treprostinil is the first listed.
NCT01027949 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01027949 about?
NCT01027949 is a clinical study titled "An Open-Label Extension Trial of UT-15C Sustained-release (SR) in Subjects With Pulmonary Arterial Hypertension". This study provided/continued to provide oral treprostinil (UT-15C SR; treprostinil diethanolamine) to eligible subjects who participated in Studies TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, and TDE-PH-308. The study assessed the long term safety of oral treprostinil and the effect...
What is the current status of trial NCT01027949?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 894 participants. The study started on 2007-01-16. Estimated completion is 2020-02-12.
What interventions are being tested in trial NCT01027949?
The interventions under investigation include: Oral Treprostinil (DRUG).
Who is sponsoring clinical trial NCT01027949?
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 NCT01027949's enrollment target sits among peer trials
894 363rd of 2000 higher than 1,638 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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