Study Stopped
Study stopped prior to subject enrollment.
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)
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
1 other identifier
interventional
N/A
3 countries
31
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2008
Shorter than P25 for phase_3
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2008
CompletedFirst Posted
Study publicly available on registry
September 26, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedJanuary 30, 2013
January 1, 2013
1 month
September 25, 2008
January 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in six-minute walk distance from Baseline to Week 12
12 weeks
Secondary Outcomes (12)
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
- +7 more secondary outcomes
Study Arms (4)
Placebo
PLACEBO COMPARATORplacebo
UT-15C 0.25 mg
ACTIVE COMPARATORUT-15C 0.25 mg
UT-15C 1 mg
ACTIVE COMPARATORUT-15C 1 mg
UT-15C 5 mg
ACTIVE COMPARATORUT-15C 5 mg
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Nursing or pregnant.
- Received a prostacyclin within the past 30 days.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
University of Alabama Birmingham
Birmingham, Alabama, 35294, United States
West Los Angeles VA Healthcare Center
Los Angeles, California, 90073, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
Stanford University
Stanford, California, 94305, United States
Pulmonary Hypertension Clinic
Aurora, Colorado, 80045, United States
University of Iowa Health Care
Iowa City, Iowa, 52242, United States
Kansas University Medical Center
Kansas City, Kansas, 66160, United States
Maine Medical Center
Portland, Maine, 04102, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55902, United States
Washington University Hospital
St Louis, Missouri, 63110, United States
Weill Cornell Medical Center
New York, New York, 10021, United States
Columbia Presbyterian Medical Center
New York, New York, 10032, United States
Mary M Parkes Center for Asthma, Allergy and Pulmonary Care - University of Rochester
Rochester, New York, 14643, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
Lagacy Clinic Northwest
Portland, Oregon, 97210, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
University of Texas Southwestern
Dallas, Texas, 75235, United States
Intermountain Medical Center
Murray, Utah, 84157-7000, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, 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, 14080, Mexico
Unidad de Investigacion Clinica en Medicina (UDICEM)
Monterrey, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kevin Laliberte, PharmD
United Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 25, 2008
First Posted
September 26, 2008
Study Start
December 1, 2008
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
January 30, 2013
Record last verified: 2013-01