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NCT01104870 · ClinicalTrials.gov registry record · Phase 2
A Dose Response Study of UT-15C SR in Patients With Exercise-Induced Pulmonary Hypertension
A Phase 2 study, sponsored by United Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT01104870: Completed Phase 2 study, sponsored by United Therapeutics.
NCT01104870 is a Phase 2 study that has completed, run by United Therapeutics. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01104870, a Phase 2 study, has completed, sponsored by United Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
This is a prospective, randomized, parallel group study to assess the hemodynamic effect of three different dose regimens of a sustained release (SR) tablet of UT-15C in patients with exercise-induced pulmonary hypertension (PH), as measured by the change in peak total pulmonary resistance index (TPRI) during exercise from Baseline to Week 12.
Primary Outcome
The effects of 12-week treatment with different doses of UT-15C on peak TPRI during exercise will be evaluated by comparing the change from Baseline to Week 12 at peak wattage on a pairwise basis between treatment groups. The primary measure of efficacy was the change from Baseline to Week 12 in peak TPRI during exercise assessed 3 to 6 hours after the subject's morning dose of UT-15C to obtain measurements at peak concentrations of treprostinil. The equation used to determine the Total Pulmona
Interventions
- DRUG UT-15C
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2010-04 |
| Est. Completion | 2013-01 |
| Phase | Phase 2 |
What the finished NCT01104870 record still lists
NCT01104870 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which UT-15C is the first listed.
NCT01104870 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01104870 about?
NCT01104870 is a clinical study titled "A Dose Response Study of UT-15C SR in Patients With Exercise-Induced Pulmonary Hypertension". This is a prospective, randomized, parallel group study to assess the hemodynamic effect of three different dose regimens of a sustained release (SR) tablet of UT-15C in patients with exercise-induced pulmonary hypertension (PH), as measured by the change in peak total pulmonary resistance index (TP...
What is the current status of trial NCT01104870?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2010-04. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01104870?
The interventions under investigation include: UT-15C (DRUG).
Who is sponsoring clinical trial NCT01104870?
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 NCT01104870's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 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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