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)
A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects With Pulmonary Arterial Hypertension
1 other identifier
interventional
354
13 countries
68
Brief Summary
This study was an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who were currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits occurred at 4 week intervals for 16 weeks; the key measure of efficacy was the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. One optional substudy was also a part of FREEDOM-C at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 16. Patients who completed all assessments for 16-weeks were also eligible to enter an open-label, extension phase study (FREEDOM - EXT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2006
Typical duration for phase_3
68 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
May 11, 2006
CompletedFirst Posted
Study publicly available on registry
May 12, 2006
CompletedStudy Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
June 10, 2013
CompletedAugust 2, 2017
July 1, 2017
1.9 years
May 11, 2006
January 18, 2013
July 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Six Minute Walk Distance (6MWD)
Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 16, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS). The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.
Baseline and 16 Weeks
Secondary Outcomes (8)
Borg Dyspnea Score
Baseline and 16 Weeks
Clinical Worsening Assessment
Baseline and 16 Weeks
Dyspnea-Fatigue Index
Baseline and 16 Weeks
World Health Organization Functional Classification for PAH
Week 16
Six Minute Walk Distance (6MWD)
Baseline and 12 weeks
- +3 more secondary outcomes
Study Arms (2)
Active
ACTIVE COMPARATORSubjects assigned to active therapy with UT-15C 0.25, 0.5, 1, or 5 mg oral tablets.
Placebo Arm
PLACEBO COMPARATORSubjects assigned to placebo 0.25, 0.5, 1, or 5 mg oral tablets.
Interventions
UT-15C 0.25, 0.5, 1, or 5 mg oral tablets by mouth every 12 hours
Eligibility Criteria
You may qualify if:
- Between 12 and 70 years of age, inclusive.
- 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.
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 (72)
University of Alabama-Birmingham
Birmingham, Alabama, 35294, United States
Arizona Pulmonary Specialist
Phoenix, Arizona, 85013, United States
University of Arizona Health Science Center
Tucson, Arizona, 85724, United States
West Los Angeles VA Healthcare Center
Los Angeles, California, 90073, United States
Stanford University, Pulmonary and Critical Care
Palo Alto, California, 94305, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
University of California-San Francisco
San Francisco, California, 94143, United States
Harbour-UCLA Medical Center
Torrance, California, 90502, United States
The Children's Hospital
Aurora, Colorado, 80218, United States
Pulmonary Hypertension Clinic
Aurora, Colorado, 80262, United States
University of Chicago
Chicago, Illinois, 60637, United States
University of Iowa Health Care
Iowa City, Iowa, 52242, United States
Maine Medical Center
Portland, Maine, 04102, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
John's Hopkins Hospital
Baltimore, Maryland, 21205, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University Hospital
St Louis, Missouri, 63110, United States
Columbia Presbyterian Medical Center
New York, New York, 10032, United States
Mary M Parkes Center for Asthma, Allergy and Pulmonary Care
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
Legacy Clinic Northwest
Portland, Oregon, 97239, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
UT Southwestern
Dallas, Texas, 75235, United States
Baylor College of Medicine, Pulmonary & Critical Care
Houston, Texas, 77030, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Intermountain Medical Center
Murray, Utah, 84143, United States
Inova Transplant Center
Fairfax, Virginia, 22042, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Heart Care Associates
Milwaukee, Wisconsin, 53215, 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, V5Z 3J5, Canada
Lab London Health Sciences Center
London, Ontario, N6A 4G5, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2N2, Canada
SMBD Jewish General Hospital
Montreal, Quebec, H3T 1E2, 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
Related Publications (2)
Lachant D, Raina A, Krishnan M, Sood N, Balasubramanian V, Barbera JA, Kiely DG, Lee D, Wu B, Hwang S, Seaman S, Broderick M, Elwing J. Efficacy and Safety of Oral Treprostinil in Patients with Pulmonary Arterial Hypertension on Background Monotherapy or Dual Therapy. Adv Ther. 2026 Feb 2. doi: 10.1007/s12325-026-03497-4. Online ahead of print.
PMID: 41627369DERIVEDTapson 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.
PMID: 22628490DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kevin Laliberte, PharmD; Senior Director, Product Development
- Organization
- United Therapeutics Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
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
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2006
First Posted
May 12, 2006
Study Start
October 1, 2006
Primary Completion
September 1, 2008
Study Completion
December 1, 2010
Last Updated
August 2, 2017
Results First Posted
June 10, 2013
Record last verified: 2017-07