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Sponsored by: |
United Therapeutics |
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Information provided by: | United Therapeutics |
ClinicalTrials.gov Identifier: | NCT00887978 |
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).
Condition | Intervention | Phase |
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Pulmonary Hypertension |
Drug: UT-15C |
Phase III |
Study Type: | Interventional |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- A subject is eligible for inclusion in this study if all of the following criteria apply:
The subject has pulmonary function tests done within 6 months of Baseline with the following:
Exclusion Criteria:
A subject is not eligible for inclusion in this study if any of the following criteria apply:
The subject has any disease associated with PAH other than collagen vascular disease, HIV infection, or appetite suppressant / toxin use (e.g.
portal hypertension, chronic thromboembolic disease, pulmonary veno-occlusive disease, etc.) or has had an atrial septostomy.
Contact: Brett Goetz, RN | 919-425-8168 | bgoetz@unither.com |
Contact: Kevin Laliberte, PharmD | 919-425-8176 | klaliberte@unither.com |
Study ID Numbers: | TDE-PH-308 |
Study First Received: | April 23, 2009 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00887978 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases Treprostinil |
Idiopathic Pulmonary Hypertension Vascular Diseases Hypertension |
Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases |
Vascular Diseases Cardiovascular Diseases Hypertension |