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NCT01560637 · ClinicalTrials.gov registry record · Phase 3
An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension
A Phase 3 study, sponsored by United Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 471
- Enrollment target
NCT01560637: Completed Phase 3 study, sponsored by United Therapeutics.
NCT01560637 is a Phase 3 study that has completed, run by United Therapeutics. The registered enrollment target is 471 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01560637, a Phase 3 study, has completed, sponsored by United Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 471 participants
- Enrollment target
Study Summary
This study is an international, multi-center, open-label study designed to provide oral treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have completed the TDE-PH-310 study. The purpose of this study is to assess the long-term safety of UT-15C and to assess the effects of long-term treatment with UT-15C on exercise capacity.
Primary Outcome
All subjects who received oral treprostinil in TDE-PH-311 were included in the Safety population. All AEs were captured from the time the ICF was signed. All AEs were followed until resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for up to 30 days if the AE extended beyond the final visit. All SAEs were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more t
Interventions
- DRUG UT-15C (treprostinil diolamine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 471 participants |
| Start Date | 2013-09-11 |
| Est. Completion | 2021-08-12 |
| Phase | Phase 3 |
What the finished NCT01560637 record still lists
NCT01560637 is an interventional study that assigns participants to a tested intervention. The registered 471 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% lower).
The record links to 0 conditions, and to 1 intervention - of which UT-15C (treprostinil diolamine) is the first listed.
NCT01560637 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01560637 about?
NCT01560637 is a clinical study titled "An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension". This study is an international, multi-center, open-label study designed to provide oral treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have completed the TDE-PH-310 study. The purpose of this study is to assess the long-term safety of UT-15C and to assess the eff...
What is the current status of trial NCT01560637?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 471 participants. The study started on 2013-09-11. Estimated completion is 2021-08-12.
What interventions are being tested in trial NCT01560637?
The interventions under investigation include: UT-15C (treprostinil diolamine) (DRUG).
Who is sponsoring clinical trial NCT01560637?
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 NCT01560637's enrollment target sits among peer trials
471 812th of 2000 higher than 1,188 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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