FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)
Public ClinicalTrials.gov record NCT00325403. 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 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison 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 was an international, multicenter, randomized (2:1 active:placebo), double-blind, placebo-controlled study in subjects with PAH who were NOT currently receiving approved therapy for their PAH. Study visits occurred at 4 week intervals for 12 weeks (with an additional visit at Week 11) with the key measure of efficacy being the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. Two optional substudies were also a part of FREEDOM-M at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 12 and a genetics and biomarkers substudy with blood samples collected at Baseline and Week 12. Patients who completed all assessments for 12 weeks were also eligible to enter an open-label, extension phase study (FREEDOM - EXT).
Study identification
- NCT ID
- NCT00325403
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 349 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 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
- Oct 2006 (Type not available)
- Primary completion
- Apr 2011 (Actual)
- Completion
- Apr 2011 (Actual)
- Last update posted
- Jan 3, 2024
2006 – 2011
United States locations
- U.S. sites
- 43
- U.S. states
- 27
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama-Birmingham | Birmingham | Alabama | — | — |
| Arizona Pulmonary Specialist | Phoenix | Arizona | — | — |
| Mayo Clinic Arizona | Phoenix | Arizona | — | — |
| University of California, San Francisco-Fresno | Fresno | California | — | — |
| West Los Angeles VA Healthcare Center | Los Angeles | California | — | — |
| UC Davis Medical Center | Sacramento | California | — | — |
| Harbor-UCLA Medical Center | Torrance | California | — | — |
| University of Colorado Health Science Center | Aurora | Colorado | — | — |
| University of Florida - Shands Hospital | Jacksonville | Florida | — | — |
| Cleveland Clinic Florida | Weston | Florida | — | — |
| Emory University Hospital | Atlanta | Georgia | — | — |
| University of Chicago Hospitals | Chicago | Illinois | — | — |
| University of Iowa Hospital and Clinics | Iowa City | Iowa | — | — |
| Kentuckiana Pulmonary Associates | Louisville | Kentucky | — | — |
| Alexandria Cardiology Clinic | Alexandria | Louisiana | — | — |
| Maine Medical Center | Portland | Maine | — | — |
| University of Maryland School of Medicine | Baltimore | Maryland | — | — |
| Brigham and Women's Hospital | Boston | Massachusetts | — | — |
| Tufts Medical Center | Boston | Massachusetts | — | — |
| University of Michigan | Ann Arbor | Michigan | — | — |
| Mayo Clinic | Rochester | Minnesota | — | — |
| Washington University Hospital | St Louis | Missouri | — | — |
| Nebraska Medical Center | Omaha | Nebraska | — | — |
| Newark Beth Israel Medical Center | Newark | New Jersey | — | — |
| Winthrop University Hospital | Mineola | New York | — | — |
| Columbia Presbyterian Medical Center | New York | New York | — | — |
| Mary M Parkes Center for Asthma, Allergy and Pulmonary Care - University of Rochester | Rochester | New York | — | — |
| The Lindner Center | Cincinnati | Ohio | — | — |
| University of Cincinnati | Cincinnati | Ohio | — | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | — | — |
| University Hospitals of Cleveland | Cleveland | Ohio | — | — |
| Ohio State University | Columbus | Ohio | — | — |
| Legacy Clinic Northwest | Portland | Oregon | — | — |
| Oregon Health and Science University | Portland | Oregon | — | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | — | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | — | — |
| Medical University of South Carolina | Charleston | South Carolina | — | — |
| University of Texas Southwestern | Dallas | Texas | — | — |
| Baylor College of Medicine, Pulmonary & Critical Care | Houston | Texas | — | — |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | — | — |
| Inova Fairfax Hospital | Falls Church | Virginia | — | — |
| University of Washington Medical Center | Seattle | Washington | — | — |
| Heart Care Associates | Milwaukee | Wisconsin | — | — |
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 34 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00325403, 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 3, 2024 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00325403 live on ClinicalTrials.gov.