FREEDOM DR: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor or as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)
Public ClinicalTrials.gov record NCT00760916. 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
FREEDOM DR: An International, Multi-Center, 12-Week, Double Blind, Randomized, Placebo-Controlled, Parallel Group Study Followed by a 12-Week Open-Label Extension Study to Assess the Efficacy, Safety, and Dose Response of UT-15C SR in Subjects With Pulmonary 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)or as a monotherapy treatment. Study visits will occur at 4 week intervals for 12 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. At the end of the first 12-weeks, the patient will be un-blinded. Patients will continue with another 12-Week open label portion with visits occuring at 4-week intervals. Patients who complete all assessments for 24-weeks will also be eligible to enter a 36 month open-label, extension phase study (FREEDOM - EXT).
Study identification
- NCT ID
- NCT00760916
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 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
- Dec 2008 (Type not available)
- Primary completion
- Jan 2009 (Actual)
- Completion
- Jan 2009 (Actual)
- Last update posted
- Jan 30, 2013
2008 – 2009
United States locations
- U.S. sites
- 26
- U.S. states
- 17
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35294 | — |
| West Los Angeles VA Healthcare Center | Los Angeles | California | 90073 | — |
| UC Davis Medical Center | Sacramento | California | 95817 | — |
| Stanford University | Stanford | California | 94305 | — |
| Pulmonary Hypertension Clinic | Aurora | Colorado | 80045 | — |
| University of Iowa Health Care | Iowa City | Iowa | 52242 | — |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | — |
| Maine Medical Center | Portland | Maine | 04102 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic | Rochester | Minnesota | 55902 | — |
| Washington University Hospital | St Louis | Missouri | 63110 | — |
| Weill Cornell Medical Center | New York | New York | 10021 | — |
| Columbia Presbyterian Medical Center | New York | New York | 10032 | — |
| Mary M Parkes Center for Asthma, Allergy and Pulmonary Care - University of Rochester | 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 | — |
| Lagacy Clinic Northwest | Portland | Oregon | 97210 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| University of Texas Southwestern | Dallas | Texas | 75235 | — |
| Intermountain Medical Center | Murray | Utah | 84157-7000 | — |
| Inova Fairfax Hospital | 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 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00760916, 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 30, 2013 · Synced Oct 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00760916 live on ClinicalTrials.gov.