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) - Full Text View

Sponsor:	United Therapeutics
Information provided by:	United Therapeutics
ClinicalTrials.gov Identifier:	NCT00325442

Purpose

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. One optional substudy is also a part of FREEDOM-C at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 16.

Patients who complete all assessments for 16-weeks will also be eligible to enter a 36 month open-label, extension phase study (FREEDOM - EXT).

Condition	Intervention	Phase
Pulmonary Hypertension	Drug: Oral treprostinil (UT-15C) Sustained Release Tablets	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: U 62840 Remodulin

U.S. FDA Resources

Further study details as provided by United Therapeutics:

Primary Outcome Measures:

Change in 6-minute walk distance from Baseline to Week 16

Secondary Outcome Measures:

Borg dyspnea score
Clinical Worsening Assessment
Dyspnea-Fatigue Index
World Health Organization Functional Classification for PAH
Symptoms of PAH
Adverse events
Clinical laboratory parameters
Electrocardiogram findings

Estimated Enrollment:	300
Study Start Date:	May 2006

Eligibility

Ages Eligible for Study:	12 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Between 12 and 70 years of age, inclusive.
Body weight at least 45 kg (approximately 100 pounds).
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.
Previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of PAH.
Reliable and cooperative with protocol requirements.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325442

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Locations

United States, Alabama
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Arizona Pulmonary Specialist
Phoenix, Arizona, United States, 85013
University of Arizona Health Science Center
Tucson, Arizona, United States, 85724
United States, California
LABiomedical Research Institute at Harbor-UCLA
Torrance, California, United States, 90502
UC Davis Medical Center
Sacramento, California, United States, 95817
University of California San Francisco, Moffitt Hospital
San Francisco, California, United States, 94143
Stanford University
Stanford, California, United States, 94305
West Los Angeles VA Healthcare Center
Los Angeles, California, United States, 90073
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
The Children's Hospital
Denver, Colorado, United States, 80218
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington University Hospital
St. Louis, Missouri, United States, 63110
United States, New York
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
Mary M Parkes Center for Asthma, Allergy and Pulmonary Care - University of Rochester
Rochester, New York, United States, 14643
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
West Penn Allegheny Health System
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
University of Texas Southwestern
Dallas, Texas, United States, 75235
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
United States, Utah
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
United States, Wisconsin
Heart Care Associates
Milwaukee, Wisconsin, United States, 53215
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia
Royal Perth Hospital
Perth, Australia
The Alfred Hospital
Melbourne, Australia
Prince Charles Hospital
Brisbane, Australia
Australia, New South Wales
St. Vincent's Hospital
Sydney, New South Wales, Australia
Austria
Universitaet Wien
Wien, Austria
Medizinische Universität Innsbruck
Innsbruck, Austria
Belgium
University Hospital Gasthuisberg
Leuven, Belgium
Universite Libre de Bruxelles
Bruxelles, Belgium
Canada, Alberta
Calgary Health Region
Calgary, Alberta, Canada
Canada, British Columbia
Vancouver Coastal Health
Vancouver, British Columbia, Canada, V5Z 3J5
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
Lab London Health Sciences Center
London, Ontario, Canada, N6A 4G5
Canada, Quebec
SMBD Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
France
Hospital Antoine Beclere
Clamart, France
Ireland
Mater Misericordiae University
Dublin, Ireland
Israel
Pulmonary Institute - Rabin MC Kampus
Petach Tikva, Israel
Pulmonary Institute - Tel Hashomer MC
Ramat Gan, Israel
Pulmonary Institute - Hadassah MC
Jerusalem, Israel
Italy
Universita degli Studi Bologna
Bologna, Italy
Universita "La Sapienza"
Rome, Italy
Netherlands
VUMC
Amsterdam, Netherlands
Poland
National Tuberculosis and Lung Disease Research Institute
Warszawa, Poland
Spain
Hospital 12 de Octubre
Madrid, Spain
Isabel Blanco Vich. Hospital Clinic
Barcelona, Spain
Hospital Valle Hebron
Barcelona, Spain
United Kingdom
Scottish Pulmonary Vascular Institute
Glasgow, United Kingdom
Freeman Hospital
Newcastle Upon Tyne, United Kingdom
Royal Free Hospital NHS Trust
London, United Kingdom
United Kingdom, England
Papworth Hospital
Cambridge, England, United Kingdom

Sponsors and Collaborators

United Therapeutics

More Information

No publications provided

Study ID Numbers:	TDE-PH-301
Study First Received:	May 11, 2006
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00325442 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by United Therapeutics:

Pulmonary Arterial Hypertension

Additional relevant MeSH terms:

Respiratory Tract Diseases
Hypertension, Pulmonary
Therapeutic Uses
Lung Diseases
Treprostinil
Vascular Diseases

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Hypertension

ClinicalTrials.gov processed this record on November 30, 2009