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)
NCT ID: NCT00760916
Last Updated: 2013-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2008-12-31
2009-01-31
Brief Summary
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Patients who complete all assessments for 24-weeks will also be eligible to enter a 36 month open-label, extension phase study (FREEDOM - EXT).
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Detailed Description
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Patients who complete all assessments for 24-weeks will also be eligible to enter a 36 month open-label, extension phase study (FREEDOM - EXT).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
placebo
Placebo
Placebo
UT-15C 0.25 mg
UT-15C 0.25 mg
UT-15C 0.25 mg
UT-15C 0.25 mg
UT-15C 1 mg
UT-15C 1 mg
UT-15C 1 mg
UT-15C 1 mg
UT-15C 5 mg
UT-15C 5 mg
UT-15C 5 mg
UT-15C 5 mg
Interventions
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UT-15C 1 mg
UT-15C 1 mg
UT-15C 0.25 mg
UT-15C 0.25 mg
UT-15C 5 mg
UT-15C 5 mg
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Body weight at least 50 kilograms
* PAH that is either idiopathic/familial; associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); associated with collagen vascular disease; associated with HIV.
* Currently receiving an approved endothelin receptor antagonist and/or an approved phosphodiesterase-5 inhibitor for at least 90 days and on a stable dose for at least the last 30 days or not currently receiving approved PAH therapy.
* Previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of PAH.
* Reliable and cooperative with protocol requirements.
* History of uncontrolled sleep apnea, renal insufficiency, anemia, left sided heart disease, uncontrolled systemic hypertension, or parenchymal lung disease.
* Use of an investigational drug within 30 days of Baseline
Exclusion Criteria
* Received a prostacyclin within the past 30 days.
18 Years
70 Years
ALL
No
Sponsors
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United Therapeutics
INDUSTRY
Responsible Party
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United Therapeutics
Principal Investigators
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Kevin Laliberte, PharmD
Role: STUDY_DIRECTOR
United Therapeutics
Locations
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University of Alabama Birmingham
Birmingham, Alabama, United States
West Los Angeles VA Healthcare Center
Los Angeles, California, United States
UC Davis Medical Center
Sacramento, California, United States
Stanford University
Stanford, California, United States
Pulmonary Hypertension Clinic
Aurora, Colorado, United States
University of Iowa Health Care
Iowa City, Iowa, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Maine Medical Center
Portland, Maine, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University Hospital
St Louis, Missouri, United States
Weill Cornell Medical Center
New York, New York, United States
Columbia Presbyterian Medical Center
New York, New York, United States
Mary M Parkes Center for Asthma, Allergy and Pulmonary Care - University of Rochester
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Lagacy Clinic Northwest
Portland, Oregon, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
University of Texas Southwestern
Dallas, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
St. Vincent's Hospital
Sydney, New South Wales, Australia
Prince Charles Hospital
Brisbane, , Australia
The Alfred Hospital
Melbourne, , Australia
Instituto Nacional de Cardiologia
Mexico City, Mexico City, Mexico
Unidad de Investigacion Clinica en Medicina (UDICEM)
Monterrey, , Mexico
Countries
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Other Identifiers
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TDE-PH-303
Identifier Type: -
Identifier Source: org_study_id
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