FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH)
NCT ID: NCT00325442
Last Updated: 2017-08-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
354 participants
INTERVENTIONAL
2006-10-31
2010-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Patients who completed all assessments for 16-weeks were also eligible to enter an open-label, extension phase study (FREEDOM - EXT).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)
NCT00325403
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)
NCT00760916
Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension
NCT00887978
An Open-Label Extension Trial of UT-15C Sustained-release (SR) in Subjects With Pulmonary Arterial Hypertension
NCT01027949
Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral Monotherapy
NCT01560624
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active
Subjects assigned to active therapy with UT-15C 0.25, 0.5, 1, or 5 mg oral tablets.
Oral treprostinil (UT-15C) sustained release tablets
UT-15C 0.25, 0.5, 1, or 5 mg oral tablets by mouth every 12 hours
Placebo Arm
Subjects assigned to placebo 0.25, 0.5, 1, or 5 mg oral tablets.
Placebo
Placebo 0.25, 0.5, 1, or 5 mg oral tablets by mouth every 12 hours
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Oral treprostinil (UT-15C) sustained release tablets
UT-15C 0.25, 0.5, 1, or 5 mg oral tablets by mouth every 12 hours
Placebo
Placebo 0.25, 0.5, 1, or 5 mg oral tablets by mouth every 12 hours
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Body weight at least 45 kg (approximately 100 pounds).
* PAH that is either idiopathic/heritable (including PAH associated with appetite suppressant/toxin use); PAH associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); PAH associated with collagen vascular disease; or PAH associated with HIV.
* Baseline 6-minute walk distance between 150 and 450 meters, inclusive.
* 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.
* 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.
12 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
United Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama-Birmingham
Birmingham, Alabama, United States
Arizona Pulmonary Specialist
Phoenix, Arizona, United States
University of Arizona Health Science Center
Tucson, Arizona, United States
West Los Angeles VA Healthcare Center
Los Angeles, California, United States
Stanford University, Pulmonary and Critical Care
Palo Alto, California, United States
UC Davis Medical Center
Sacramento, California, United States
University of California-San Francisco
San Francisco, California, United States
Harbour-UCLA Medical Center
Torrance, California, United States
The Children's Hospital
Aurora, Colorado, United States
Pulmonary Hypertension Clinic
Aurora, Colorado, United States
University of Chicago
Chicago, Illinois, United States
University of Iowa Health Care
Iowa City, Iowa, United States
Maine Medical Center
Portland, Maine, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
John's Hopkins Hospital
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University Hospital
St Louis, Missouri, United States
Columbia Presbyterian Medical Center
New York, New York, United States
Mary M Parkes Center for Asthma, Allergy and Pulmonary Care
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
Legacy Clinic Northwest
Portland, Oregon, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
UT Southwestern
Dallas, Texas, United States
Baylor College of Medicine, Pulmonary & Critical Care
Houston, Texas, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Inova Transplant Center
Fairfax, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Heart Care Associates
Milwaukee, Wisconsin, United States
St. Vincent's Hospital
Sydney, New South Wales, Australia
The Prince Charles Hospital
Brisbane, , Australia
The Alfred Hospital
Melbourne, , Australia
Royal Perth Hospital
Perth, , Australia
Medizinische Universität Innsbruck
Innsbruck, , Austria
Universitaet Wien
Vienna, , Austria
Hospital Erasme
Brussels, , Belgium
University Hospital Gasthuisberg
Leuven, , Belgium
Respiratory Research
Calgary, Alberta, Canada
Vancouver Coastal Health Respiratory Clinic
Vancouver, British Columbia, Canada
Lab London Health Sciences Center
London, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
SMBD Jewish General Hospital
Montreal, Quebec, Canada
Hospital Cavale Blanche
Brest, , France
Hospital Antoine Beclere
Clamart, , France
Hospital Claude Huriez
Lille, , France
Hôpital Louis Pradel
Lyon, , France
Medizinische Hochschule Hannover
Hanover, , Germany
Mater Misericordiae University Hospital Ltd
Dublin, , Ireland
Hadassah Ein-Kerem Medical Center
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Tel Hashomer Medical Center
Ramat Gan, , Israel
Universita degli Studi Bologna
Bologna, , Italy
Universita "La Sapienza" Roma
Rome, , Italy
Hospital Vrije Universiteit
Amsterdam, , Netherlands
National Tuberculosis and Lung Disease Research Institute
Warsaw, , Poland
Hospital Clinic of Barcelona
Barcelona, , Spain
Hospital Valle Hebron
Barcelona, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Papworth Hospital
Cambridge, , United Kingdom
Western Infirmary
Glasgow, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Freeman Hospital
Newcastle, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Tapson VF, Torres F, Kermeen F, Keogh AM, Allen RP, Frantz RP, Badesch DB, Frost AE, Shapiro SM, Laliberte K, Sigman J, Arneson C, Galie N. Oral treprostinil for the treatment of pulmonary arterial hypertension in patients on background endothelin receptor antagonist and/or phosphodiesterase type 5 inhibitor therapy (the FREEDOM-C study): a randomized controlled trial. Chest. 2012 Dec;142(6):1383-1390. doi: 10.1378/chest.11-2212.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TDE-PH-301
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.