Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension
Public ClinicalTrials.gov record NCT00887978. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial Hypertension
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT00887978
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 310 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2009
- Primary completion
- Jun 30, 2011
- Completion
- Jun 30, 2011
- Last update posted
- Jan 14, 2013
2009 – 2011
United States locations
- U.S. sites
- 40
- U.S. states
- 24
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama-Birmingham | Birmingham | Alabama | 35294-0006 | — |
| Arizona Pulmonary Specialist, LTD | Phoenix | Arizona | 85013 | — |
| University of California, San Francisco-Fresno | Fresno | California | 93701 | — |
| UCSD Medical Center | La Jolla | California | 92037 | — |
| West Los Angeles VA Healthcare Center | Los Angeles | California | 90073 | — |
| UC Davis Medical Center | Sacramento | California | 95817 | — |
| Harbor-UCLA Medical Center | Torrance | California | 90502 | — |
| University of Colorado Health Science Center | Aurora | Colorado | 80045 | — |
| University of Florida-Jacksonville | Jacksonville | Florida | 32209 | — |
| Cleveland Clinic Florida | Weston | Florida | 33331 | — |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | — |
| University of Chicago Hospitals | Chicago | Illinois | 60637 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | — |
| Kentuckiana Pulmonary Associates | Louisville | Kentucky | 40202 | — |
| Maine Medical Center | Portland | Maine | 04102-3175 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Pulmonary Critical Care Medicine, Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Mayo Clinic | Rochester | Minnesota | 55902 | — |
| Washington University Hospital | St Louis | Missouri | 63110-1093 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-5300 | — |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | — |
| Winthrop University Hospital | Mineola | New York | 11501 | — |
| Columbia University Presbyterian Medical Center | New York | New York | 10032 | — |
| Mary M Parkes Center for Asthma, Allergy and Pulmonary Care | Rochester | New York | 14623 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Lindner Center | Cincinnati | Ohio | 45219 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267-0564 | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| The University of Toledo | Toledo | Ohio | 43614 | — |
| Legacy Pulmonary Northwest | Portland | Oregon | 97210 | — |
| OHSU | Portland | Oregon | 97239 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| UT Southwestern | Dallas | Texas | 75390 | — |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
| Intermountain Medical Center | Murray | Utah | 84157-7000 | — |
| Inova Transplant Center | Falls Church | Virginia | 22042 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 22 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00887978, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 14, 2013 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00887978 live on ClinicalTrials.gov.