Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension
FREEDOM-C2
A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial Hypertension
1 other identifier
interventional
310
12 countries
62
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). Study visits will occur at 4 week intervals for 16 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. Patients who complete all assessments for 16-weeks will also be 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 Jun 2009
62 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
April 23, 2009
CompletedFirst Posted
Study publicly available on registry
April 24, 2009
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
January 15, 2013
CompletedJanuary 15, 2013
December 1, 2012
2.1 years
April 23, 2009
November 2, 2012
December 7, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
6-minute Walk Distance (6MWD)
Placebo-corrected change in 6MWD from Baseline to Week 16, correlates with the current 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 6MWD was to be assessed between 3 and 6 hours after the morning dose of study drug and background therapy(ies).
Baseline and 16 weeks
Secondary Outcomes (7)
Clinical Worsening Assessment
Baseline and 16 Weeks
Borg Dyspnea Score
Baseline and 16 Weeks
World Health Organization (WHO) Functional Class
Baseline and 16 Weeks
Symptoms of PAH
Baseline and 16 Weeks
Dyspnea Fatigue Index
Baseline and 16 Weeks
- +2 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORIdentical placebo tablets to UT-15C, doses were titrated in the same manner
UT-15C SR
EXPERIMENTALDoses were initiated at 0.25 mg BID and increased by 0.25 mg BID every three days (as clinically indicated based on tolerability and symptoms of PAH), to a max dose of 16 mg BID.
Interventions
Eligibility Criteria
You may qualify if:
- Between 18 and 75 years of age, inclusive.
- Body weight at least 40 kg (approximately 90 lbs.)
- PAH that is either idiopathic/heritable; associated with appetite suppressant or toxin use; associated with collagen vascular disease; associated with repaired congenital shunts; 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.
- Baseline six-minute walk distance (6MWD) between 150-425 meters
- Previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of PAH.
- Reliable and cooperative with protocol requirements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
University of Alabama-Birmingham
Birmingham, Alabama, 35294-0006, United States
Arizona Pulmonary Specialist, LTD
Phoenix, Arizona, 85013, United States
University of California, San Francisco-Fresno
Fresno, California, 93701, United States
UCSD Medical Center
La Jolla, California, 92037, United States
West Los Angeles VA Healthcare Center
Los Angeles, California, 90073, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
Harbor-UCLA Medical Center
Torrance, California, 90502, United States
University of Colorado Health Science Center
Aurora, Colorado, 80045, United States
University of Florida-Jacksonville
Jacksonville, Florida, 32209, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
University of Chicago Hospitals
Chicago, Illinois, 60637, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Kansas University Medical Center
Kansas City, Kansas, 66160, United States
Kentuckiana Pulmonary Associates
Louisville, Kentucky, 40202, United States
Maine Medical Center
Portland, Maine, 04102-3175, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Pulmonary Critical Care Medicine, Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Mayo Clinic
Rochester, Minnesota, 55902, United States
Washington University Hospital
St Louis, Missouri, 63110-1093, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-5300, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Columbia University Presbyterian Medical Center
New York, New York, 10032, United States
Mary M Parkes Center for Asthma, Allergy and Pulmonary Care
Rochester, New York, 14623, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Lindner Center
Cincinnati, Ohio, 45219, United States
University of Cincinnati
Cincinnati, Ohio, 45267-0564, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
Ohio State University
Columbus, Ohio, 43210, United States
The University of Toledo
Toledo, Ohio, 43614, United States
Legacy Pulmonary Northwest
Portland, Oregon, 97210, United States
OHSU
Portland, Oregon, 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
UT Southwestern
Dallas, Texas, 75390, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Intermountain Medical Center
Murray, Utah, 84157-7000, United States
Inova Transplant Center
Falls Church, Virginia, 22042, United States
University Hospital Gasthuisberg
Leuven, 3000, Belgium
University of Calgary
Calgary, Alberta, T1Y 6J4, Canada
University of Alberta Hospitals
Edmonton, Alberta, T6G 2B7, Canada
Vancouver Coastal Health Respiratory Clinic
Vancouver, British Columbia, V5Z 1M9, Canada
London Health Sciences Center
London, Ontario, N6A 4G5, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2N2, Canada
Hospital Claude Huriez
Lille, Cedex, 59037, France
Hospital Haut Leveque
Pessac, Cedex, 33604, France
Hospital Cavale Blanche
Brest, 29609, France
Universitaetsklinikum Dresden
Dresden, 01307, Germany
University Hospital Greifswald
Greifswald, 17475, Germany
Universitaetsklinikum Heidelberg
Heidelberg, 69120, Germany
Pulmonology Department Rambam Medical Center
Haifa, 31096, Israel
Lady Davis Carmel Medical Centre
Haifa, 34362, Israel
Pulmonary institute
Ramat Gan, 52621, Israel
Azienda Ospedaliera Universitaria
Naples, Italy
VUMC
Amsterdam, 1007, Netherlands
Hospital de Santa Marta
Lisbon, 1160-024, Portugal
Hospital Clinic I Provincial de Barcelona
Barcelona, 08036, Spain
Hospital 12 de Octubre
Madrid, 28041, Spain
Lund University Hospital
Lund, 221 85, Sweden
Royal Free Hospital NHS Trust
London, NW3 2QG, United Kingdom
Related Publications (3)
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: 41627369DERIVEDRichter MJ, Schermuly R, Seeger W, Rao Y, Ghofrani HA, Gall H. Relevance of angiopoietin-2 and soluble P-selectin levels in patients with pulmonary arterial hypertension receiving combination therapy with oral treprostinil: a FREEDOM-C2 biomarker substudy. Pulm Circ. 2016 Dec;6(4):516-523. doi: 10.1086/688671.
PMID: 28090293DERIVEDTapson VF, Jing ZC, Xu KF, Pan L, Feldman J, Kiely DG, Kotlyar E, McSwain CS, Laliberte K, Arneson C, Rubin LJ; FREEDOM-C2 Study Team. Oral treprostinil for the treatment of pulmonary arterial hypertension in patients receiving background endothelin receptor antagonist and phosphodiesterase type 5 inhibitor therapy (the FREEDOM-C2 study): a randomized controlled trial. Chest. 2013 Sep;144(3):952-958. doi: 10.1378/chest.12-2875.
PMID: 23669822DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kevin Laliberte, PharmD
- Organization
- United Therapeutics Corporation
Study Officials
- STUDY CHAIR
Lewis Rubin, MD
University of California, San Diego
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2009
First Posted
April 24, 2009
Study Start
June 1, 2009
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
January 15, 2013
Results First Posted
January 15, 2013
Record last verified: 2012-12