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NCT01560624 · ClinicalTrials.gov registry record · Phase 3
Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral Monotherapy
A Phase 3 study, sponsored by United Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 690
- Enrollment target
NCT01560624: Completed Phase 3 study, sponsored by United Therapeutics.
NCT01560624 is a Phase 3 study that has completed, run by United Therapeutics. The registered enrollment target is 690 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01560624, a Phase 3 study, has completed, sponsored by United Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 690 participants
- Enrollment target
Study Summary
This is an international, multicenter, randomized, double-blind, placebo-controlled, event driven study in subjects with pulmonary arterial hypertension.
Primary Outcome
Clinical worsening was assessed continuously from randomization until the subject's last study visit. Clinical worsening events were defined as death (all causes), hospitalizations due to worsening pulmonary arterial hypertension (PAH), initiation of an inhaled or infused prostacyclin (PGI2) for the treatment of worsening PAH, disease progression, or unsatisfactory long-term clinical response. All clinical worsening events reported by the study sites were reviewed by the Sponsor Medical Monitors
Interventions
- DRUG Placebo
- DRUG Treprostinil Diolamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 690 participants |
| Start Date | 2012-06-26 |
| Est. Completion | 2018-06-24 |
| Phase | Phase 3 |
What the finished NCT01560624 record still lists
NCT01560624 is an interventional study that assigns participants to a tested intervention. The registered 690 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 (11% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01560624 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01560624 about?
NCT01560624 is a clinical study titled "Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral Monotherapy". This is an international, multicenter, randomized, double-blind, placebo-controlled, event driven study in subjects with pulmonary arterial hypertension.
What is the current status of trial NCT01560624?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 690 participants. The study started on 2012-06-26. Estimated completion is 2018-06-24.
What interventions are being tested in trial NCT01560624?
The interventions under investigation include: Placebo (DRUG), Treprostinil Diolamine (DRUG).
Who is sponsoring clinical trial NCT01560624?
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 NCT01560624's enrollment target sits among peer trials
690 524th of 2000 higher than 1,476 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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