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)
- Conditions
- Pulmonary Hypertension
- Interventions
- Drug: PlaceboDrug: UT-15C 0.25 mgDrug: UT-15C 1 mgDrug: UT-15C 5 mg
- Registration Number
- NCT00760916
- Lead Sponsor
- United Therapeutics
- Brief Summary
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).
- Detailed Description
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).
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Between 18 and 70 years of age, inclusive
- 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.
- Nursing or pregnant.
- Received a prostacyclin within the past 30 days.
- PAH due to conditions other than noted in the above inclusion criteria.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo placebo 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 5 mg UT-15C 5 mg UT-15C 5 mg
- Primary Outcome Measures
Name Time Method Change in six-minute walk distance from Baseline to Week 12 12 weeks
- Secondary Outcome Measures
Name Time Method Borg Dyspnea Score 12 weeks Clinical Worsening Assessment 12 weeks Dyspnea Fatigue Index 12 weeks Symptoms of PAH 12 weeks World Health Organization (WHO) Functional Class 12 weeks Trough 6-Minute Walk Distance 12 weeks Trough Borg Dyspnea Score 12 weeks Pro-B-type natriuretic peptide (Pro-BNP) 12 weeks Optional hemodynamic parameters 12 weeks Adverse events 12 weeks Clinical Laboratory parameters 12 weeks Electrocardiogram findings 12 weeks
Trial Locations
- Locations (31)
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Unidad de Investigacion Clinica en Medicina (UDICEM)
🇲🇽Monterrey, Mexico
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Stanford University
🇺🇸Stanford, California, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Prince Charles Hospital
🇦🇺Brisbane, Australia
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
University of Texas Southwestern
🇺🇸Dallas, Texas, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Columbia Presbyterian Medical Center
🇺🇸New York, New York, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Weill Cornell Medical Center
🇺🇸New York, New York, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
St. Vincent's Hospital
🇦🇺Sydney, New South Wales, Australia
The Alfred Hospital
🇦🇺Melbourne, Australia
West Los Angeles VA Healthcare Center
🇺🇸Los Angeles, California, United States
University of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
University of Iowa Health Care
🇺🇸Iowa City, Iowa, United States
Mary M Parkes Center for Asthma, Allergy and Pulmonary Care - University of Rochester
🇺🇸Rochester, New York, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Pulmonary Hypertension Clinic
🇺🇸Aurora, Colorado, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Washington University Hospital
🇺🇸St. Louis, Missouri, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Lagacy Clinic Northwest
🇺🇸Portland, Oregon, United States
Instituto Nacional de Cardiologia
🇲🇽Mexico City, DF, Mexico