FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH)
Public ClinicalTrials.gov record NCT00325442. 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 Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects With Pulmonary Arterial Hypertension
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study was an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who were currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits occurred at 4 week intervals for 16 weeks; the key measure of efficacy was the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. One optional substudy was also a part of FREEDOM-C at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 16. Patients who completed all assessments for 16-weeks were also eligible to enter an open-label, extension phase study (FREEDOM - EXT).
Study identification
- NCT ID
- NCT00325442
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 354 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 70 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
- Sep 2008 (Actual)
- Completion
- Dec 2010 (Actual)
- Last update posted
- Aug 2, 2017
2006 – 2010
United States locations
- U.S. sites
- 39
- U.S. states
- 24
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama-Birmingham | Birmingham | Alabama | 35294 | — |
| Arizona Pulmonary Specialist | Phoenix | Arizona | 85013 | — |
| University of Arizona Health Science Center | Tucson | Arizona | 85724 | — |
| West Los Angeles VA Healthcare Center | Los Angeles | California | 90073 | — |
| Stanford University, Pulmonary and Critical Care | Palo Alto | California | 94305 | — |
| UC Davis Medical Center | Sacramento | California | 95817 | — |
| University of California-San Francisco | San Francisco | California | 94143 | — |
| Harbour-UCLA Medical Center | Torrance | California | 90502 | — |
| The Children's Hospital | Aurora | Colorado | 80218 | — |
| Pulmonary Hypertension Clinic | Aurora | Colorado | 80262 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| University of Iowa Health Care | Iowa City | Iowa | 52242 | — |
| Maine Medical Center | Portland | Maine | 04102 | — |
| University of Maryland School of Medicine | Baltimore | Maryland | 21201 | — |
| John's Hopkins Hospital | Baltimore | Maryland | 21205 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Washington University Hospital | St Louis | Missouri | 63110 | — |
| Columbia Presbyterian Medical Center | New York | New York | 10032 | — |
| Mary M Parkes Center for Asthma, Allergy and Pulmonary Care | Rochester | New York | 14643 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| Legacy Clinic Northwest | Portland | Oregon | 97239 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| UT Southwestern | Dallas | Texas | 75235 | — |
| Baylor College of Medicine, Pulmonary & Critical Care | Houston | Texas | 77030 | — |
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
| Intermountain Medical Center | Murray | Utah | 84143 | — |
| Inova Transplant Center | Fairfax | Virginia | 22042 | — |
| University of Washington Medical Center | Seattle | Washington | 98195 | — |
| Heart Care Associates | Milwaukee | Wisconsin | 53215 | — |
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 33 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00325442, 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 Aug 2, 2017 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00325442 live on ClinicalTrials.gov.