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NCT01477333 · ClinicalTrials.gov registry record · Phase 2
Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®
A Phase 2 study, sponsored by United Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT01477333: Completed Phase 2 study, sponsored by United Therapeutics.
NCT01477333 is a Phase 2 study that has completed, run by United Therapeutics. The registered enrollment target is 18 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01477333, a Phase 2 study, has completed, sponsored by United Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
The purpose of this multi-center, open-label, safety and tolerability study was to assess the addition of oral treprostinil (UT-15C sustained release \[SR\] tablets) to subjects currently receiving Tyvaso (treprostinil) inhalation solution. During the 24-week evaluation period, the study evaluated the changes in the following assessments: hemodynamics, 6-minute walk test (6MWT), Borg dyspnea score, N-Terminal pro-brain natriuretic peptide (NT-proBNP), World Health Organization (WHO) Functional Class, and safety assessments. Eligible subjects had a diagnosis of pulmonary arterial hypertension (PAH), currently were receiving Tyvaso, and may have been receiving other approved PAH specific oral therapies (endothelin receptor antagonists \[ERAs\] and/or phosphodiesterase type 5 inhibitor \[PDE5-I\], if at a stable dose for ≥30 days). At Baseline, subjects received the first dose of 0.125 mg UT-15C SR.
Primary Outcome
Hemodynamics (via right heart catheterization \[RHC\]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit. Cardiopulmonary hemodynamic measurements included the following: mean pulmonary arterial pressure (PAPm), mean systemic arterial pressure (SAPm), mean right atrial pressure (RAPm), and mean pulmonary capillary wedge pressure (PCWPm).
Interventions
- DRUG UT-15C SR
- DRUG Tyvaso Inhalation Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-10 |
| Est. Completion | 2013-11 |
| Phase | Phase 2 |
What the finished NCT01477333 record still lists
NCT01477333 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which UT-15C SR is the first listed.
NCT01477333 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01477333 about?
NCT01477333 is a clinical study titled "Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®". The purpose of this multi-center, open-label, safety and tolerability study was to assess the addition of oral treprostinil (UT-15C sustained release \[SR\] tablets) to subjects currently receiving Tyvaso (treprostinil) inhalation solution. During the 24-week evaluation period, the study evaluated t...
What is the current status of trial NCT01477333?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2011-10. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01477333?
The interventions under investigation include: UT-15C SR (DRUG), Tyvaso Inhalation Solution (DRUG).
Who is sponsoring clinical trial NCT01477333?
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 NCT01477333's enrollment target sits among peer trials
18 1898th of 2000 higher than 98 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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