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An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension (FREEDOM-EXT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01027949
Recruitment Status : Active, not recruiting
First Posted : December 9, 2009
Last Update Posted : September 27, 2019
Information provided by (Responsible Party):
United Therapeutics

Brief Summary:
This study provides, or continues to provide, UT-15C SR (treprostinil diethanolamine) to eligible patients with pulmonary arterial hypertension who have completed protocols TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, TDE-PH-308 studies or any additional UT-15C SR clinical protocols evaluating subjects with PAH. The study assesses the long term safety of UT-15C and the effect of continued treatment with UT-15C on exercise capacity after one year of treatment.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Treprostinil diethanolamine Phase 3

Detailed Description:
This is an open-label study. Each subject's visit schedule will allow assessments after defined periods of exposure to UT-15C SR (3, 6, 12, 24 and 36 months total exposure). The study will continue with yearly visits beyond 36 months until either UT-15C SR is approved by the appropriate regulatory authorities or the study is discontinued by the sponsor. Therefore, the actual date of each visit will be determined by the date on which the subject first received UT-15C SR (e.g., the date of study drug initiation in TDE-PH- 301, TDE-PH-302, or TDE-PH-308 for subjects who were randomized to active therapy in those trials,and the date of UT-15C SR initiation in this study for subjects who were randomized to placebo in the previous controlled trial). Note that the TDE-PH-202, TDE-PH-203, TDE-PH-205 studies are open-label design and therefore will follow the regimen for subjects receiving UT-15C SR.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension
Study Start Date : May 2006
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Treprostinil diethanolamine (UT-15C)
All open will receive active study drug
Drug: Treprostinil diethanolamine
Oral sustained release tablet, twice or thrice daily. Open label study with active drug, no other intervention arms.

Primary Outcome Measures :
  1. Continued therapy effect on exercise capacity as assessed by a 6-Minute Walk Test [ Time Frame: Once, after one year of therapy with UT-15C SR. ]
  2. Long-term safety as assessed by clinical laboratories [ Time Frame: Performed at each study scheduled visit ]
    After one year exposure to UT-15C clinical laboratorial assessments will occur 1 time/year through study completion until either drug receives regulatory approval in a particular region or the sponsor discontinues the study.

  3. Long-term safety as assessed by adverse events [ Time Frame: Performed monthly during monthly telephone calls ]
    Telephone calls will occur at a minimum 1 time/month through study completion until either drug receives regulatory approval in a particular region or the sponsor discontinues the study.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Participation in study TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302,TDE-PH-308 or any additional UT-15C SR clinical protocol is required. Subjects must complete all assessments in one of these studies to be eligible.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01027949

  Hide Study Locations
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United States, Alabama
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294-0006
United States, Arizona
Arizona Pulmonary Specialist
Phoenix, Arizona, United States, 85013
Mayo Clinic Phoenix
Phoenix, Arizona, United States, 85054
United States, California
University of California, San Francisco-Fresno
Fresno, California, United States, 93701
West Los Angeles VA Healthcare Center
Los Angeles, California, United States, 90073
UC Davis Medical Center
Sacramento, California, United States, 95817
UCSD Medical Center
San Diego, California, United States, 30322
Stanford University, Pulmonary and Critical Care
Stanford, California, United States, 94305-5351
Harbor-UCLA Medical Center
Torrance, California, United States, 90502
United States, Colorado
Pulmonary Hypertension Clinic
Aurora, Colorado, United States, 80045
United States, Florida
University of Florida - Jacksonville
Jacksonville, Florida, United States, 32209
Cleveland Clinic Florida
Weston, Florida, United States, 33331
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Iowa
University of Iowa Health Care
Iowa City, Iowa, United States, 52242
United States, Kentucky
Kentuckiana Pulmonary Associates
Louisville, Kentucky, United States, 40202
United States, Louisiana
Alexandria Cardiology Clinic
Alexandria, Louisiana, United States, 71301
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Pulmonary Critical Care Medicine, Brigham and Women's Hospital
Boston, Massachusetts, United States, 02114
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Mayo Clinic
Rochester, Minnesota, United States, 55902
United States, Missouri
Washington University Hospital
Saint Louis, Missouri, United States, 63110-1093
United States, Nebraska
Nebraska Medical Center
Omaha, Nebraska, United States, 68198-5300
United States, New Jersey
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
Mary M Parkes Center for Asthma, Allergy and Pulmonary Care
Rochester, New York, United States, 14643
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
The Lindner Research Center
Cincinnati, Ohio, United States, 45219
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0564
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
The University of Toledo
Toledo, Ohio, United States, 43614
United States, Oregon
Legacy Clinic Northwest
Portland, Oregon, United States, 97210
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-2650
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390
Baylor College of Medicine, Pulmonary & Critical Care
Houston, Texas, United States, 77030
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84157-7000
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
Aurora Health Care
Milwaukee, Wisconsin, United States, 53215
The Prince Charles Hospital
Chermside West, Australia, 4032
The Alfred Hospital
Melbourne, Australia, 3004
Royal Perth Hospital
Perth, Australia
St. Vincent's Hospital
Sydney, Australia, 2010
Medizinische Universität, Innsbruck
Innsbruck, Austria
Universitaet Wien
Wien, Austria
Universite Libre de Bruxelles
Brussels, Belgium
University Hospital Gasthuisberg
Leuven, Belgium
Canada, Alberta
University of Alberta, Respiratory Research
Calgary, Alberta, Canada, T1Y 6J4
University of Alberta Hospitals
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Vancouver Coastal Health Respiratory Clinic
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
Lab London Health Sciences Center
Toronto, Ontario, Canada, N6A 4G5
Hopital Haut Leveque
Pessac, Pessac Cedex, France, 33604
CHU de la Cavale Blanche
Brest, France
Hopital Antoine Beclere Clamart-University Paris France
Clamart, France
Hopital Huriez
Lille Cedex, France
Department of Respiratory Medicine
Lyon, France
Service maladies respiratoires- CHU-Arnaud de Villeneuve
Montpellier cedex 5, France, 34295
Medizinische Klinik Und Poliklinik I Universitatsklinikum Carl Gustav Carus Abteilung Pneumologie
Dresden, Germany, 01307
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, Germany, 01307
University Hospital Greifswald
Greifswald, Germany, 17475
University Hospital Hamburg
Hamburg, Germany
Medizinische Hochschule Hannover (MHH)
Hannover, Germany
Universitaetsklinikum Heidelberg
Heidelberg, Germany, 69120
The Heart Care Clinic
Ahmedabad, Gujarat, India, 380054
Narayana Hrudayalaya Instituteof Cardiac Sciences
Bangalore, Karnataka, India, 560034
Seth G. S. Medical College and KEM Hospital
Mumbai, Maharashtra, India, 400012
Poona Hospital and Research Centre
Pune, Maharashtra, India, 411030
Lifecare Institute of Medical Sciences & Research
Ahmedabad, India, 380054
Sri Ramachandra Medical College
Chennai, India
G. Kuppuswamy Naidu Memorial Hospital
Coimbatore, India
PRIME Hospitals
Hyderabad, India, 500038
Sir Ganga Ram Hospital
New Delhi, India, 110060
Mater Hospital
Dublin, Ireland
The Chaim Sheba Medical Center at Tel Hashomer
Tel Hashomer, Tel Aviv, Israel, 52621
Rambam Medical Center
Haifa, Israel, 31096
Pulmonary Institute
Jerusalem, Israel
Rabin Medical Center
Petah Tiqva, Israel
Pulmonary Institute
Ramat Gan, Israel
University of Bologna
Bologna, Italy
Azienda Ospedaliera Universitaria
Naples, Italy
La Sapienza University
Rome, Italy
Hospital Angeles del Carmen
Guadalajara, Mexico
Instituto Nacional de Cardiologia
Mexico City, Mexico, 14080
Hospital Universitario
Monterrey, Mexico, 64460
Unidad de Investigacion Clinica en Medicina
Monterrey, Mexico, 64718
VU University Medical Center
Amsterdam, Netherlands
Krakowski Szpital Specjalistyczny im. (Kraków Specialist Hospital)
Kraków, Poland, 31-202
Apteka Szpitalna
Warsaw, Poland
Wojewódzki Szpital Specjalistyczny we Wroclawiu (Provincial Specialist Hospital in Wrocław)
Wroclaw, Poland, 51-124
Hospital Santa Martha - Lisbon
Lisbon, Portugal
S. Joao Hospital
O'Porto, Portugal
Puerto Rico
Advanced Pulmonary Practice of Puerto Rico
Guaynabo, Puerto Rico, 00968
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Universitat de Barcelona
Barcelona, Spain
Hospital 12 de Octubre
Madrid, Spain
Universitetssjukhuset i Lund
Lund, Sweden, SE 22185
United Kingdom
Papworth Hospital
Cambridge, United Kingdom
Golden Jubilee National Hospital
Glasgow, United Kingdom
Royal Free Hospital
London, United Kingdom
Newcastle University
Newcastle, United Kingdom
Royal Hallamshire Hospital
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
United Therapeutics
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Study Director: Jeff Sigman United Therapeutics

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Responsible Party: United Therapeutics Identifier: NCT01027949     History of Changes
Other Study ID Numbers: TDE-PH-304
First Posted: December 9, 2009    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Antihypertensive Agents