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NCT01588405 · ClinicalTrials.gov registry record · Phase 2
Remodulin® to Oral Treprostinil Transition
A Phase 2 study, sponsored by United Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
NCT01588405: Completed Phase 2 study, sponsored by United Therapeutics.
NCT01588405 is a Phase 2 study that has completed, run by United Therapeutics. The registered enrollment target is 33 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01588405, a Phase 2 study, has completed, sponsored by United Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
Study Summary
This multi-center, open-label study will assess the tolerability and safety of transitioning subjects with stable Pulmonary Arterial Hypertension (PAH) from continuous intravenous (IV) or subcutaneous (SC) Remodulin infusion to oral treprostinil (UT-15C sustained release (SR) tablets). This study will consist of an in-hospital transition phase, dose optimization/evaluation phase, and follow up phase.
Primary Outcome
Successful transition was based on the number of participants that completely transitioned to oral treprostinil by the week 4 study visit and clinically maintained on oral treprostinil treatment through Week 24.
Interventions
- DRUG UT-15C SR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2012-04 |
| Est. Completion | 2014-12 |
| Phase | Phase 2 |
What the finished NCT01588405 record still lists
NCT01588405 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which UT-15C SR is the first listed.
NCT01588405 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01588405 about?
NCT01588405 is a clinical study titled "Remodulin® to Oral Treprostinil Transition". This multi-center, open-label study will assess the tolerability and safety of transitioning subjects with stable Pulmonary Arterial Hypertension (PAH) from continuous intravenous (IV) or subcutaneous (SC) Remodulin infusion to oral treprostinil (UT-15C sustained release (SR) tablets). This study w...
What is the current status of trial NCT01588405?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2012-04. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01588405?
The interventions under investigation include: UT-15C SR (DRUG).
Who is sponsoring clinical trial NCT01588405?
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 NCT01588405's enrollment target sits among peer trials
33 1553rd of 2000 higher than 438 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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