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NCT00887978 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension
A Phase 3 study of Pulmonary Hypertension, sponsored by United Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 310
- Enrollment target
- 20
- Study locations
NCT00887978: Completed Phase 3 study of Pulmonary Hypertension, sponsored by United Therapeutics.
NCT00887978 is a Phase 3 study of Pulmonary Hypertension that has completed, run by United Therapeutics. The registered enrollment target is 310 participants, below the 609-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (49% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00887978, a Phase 3 study of Pulmonary Hypertension, has completed, sponsored by United Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 310 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits will occur at 4 week intervals for 16 weeks with the key measure of efficacy being the 6-minute walk test. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. Patients who complete all assessments for 16-weeks will also be eligible to enter an open-label, extension phase study (FREEDOM - EXT).
Primary Outcome
Placebo-corrected change in 6MWD from Baseline to Week 16, correlates with the current clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS). The 6MWD was to be assessed between 3 and 6 hours after the morning dose of study drug and background therapy(ies).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG UT-15C SR
Study Locations (20)
California
- University of California, San Francisco-Fresno - Fresno
- UCSD Medical Center - La Jolla
- West Los Angeles VA Healthcare Center - Los Angeles
- UC Davis Medical Center - Sacramento
- Harbor-UCLA Medical Center - Torrance
Florida
- University of Florida-Jacksonville - Jacksonville
- Cleveland Clinic Florida - Weston
Massachusetts
- Tufts Medical Center - Boston
- Pulmonary Critical Care Medicine, Brigham and Women's Hospital - Boston
Alabama
- University of Alabama-Birmingham - Birmingham
Arizona
- Arizona Pulmonary Specialist, LTD - Phoenix
Colorado
- University of Colorado Health Science Center - Aurora
Georgia
- Emory University School of Medicine - Atlanta
Illinois
- University of Chicago Hospitals - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 310 participants |
| Start Date | 2009-06 |
| Est. Completion | 2011-07 |
| Phase | Phase 3 |
What the finished NCT00887978 record still lists
NCT00887978 is an interventional study that assigns participants to a tested intervention. The registered 310 participants enrollment target is mid-sized for trials with a published cap, below the 609-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (49% lower).
The record links to 1 condition, with Pulmonary Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00887978 names 20 study sites across 14 states, led by California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00887978 about?
NCT00887978 is a clinical study titled "Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension". This study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits will occur at 4 week intervals fo...
What is the current status of trial NCT00887978?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 310 participants. The study started on 2009-06. Estimated completion is 2011-07.
What conditions does trial NCT00887978 study?
This clinical trial studies the following conditions: Pulmonary Hypertension.
What interventions are being tested in trial NCT00887978?
The interventions under investigation include: Placebo (DRUG), UT-15C SR (DRUG).
Who is sponsoring clinical trial NCT00887978?
This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00887978 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00887978's enrollment target sits among peer trials
310 14th of 72 higher than 59 of 72 other Pulmonary Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Hypertension 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.
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