An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension
NCT ID: NCT01560637
Last Updated: 2022-06-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
471 participants
INTERVENTIONAL
2013-09-11
2021-08-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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UT-15C
Open label access
UT-15C (treprostinil diolamine)
UT-15C extended release oral tablet three times daily
Interventions
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UT-15C (treprostinil diolamine)
UT-15C extended release oral tablet three times daily
Eligibility Criteria
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Inclusion Criteria
* All women of childbearing potential (WOCBP) must have practiced true abstinence from intercourse when it was in line with their preferred and usual lifestyle or used 2 different forms of highly effective contraception for the duration of the study and for at least 30 days after discontinuing study medication.
* Males who participated in the study must have used a condom during the length of the study and for at least 48 hours after their last dose of study medication.
Exclusion Criteria
* The subject had received infused or inhaled prostacyclin therapy for 29 days or more.
* The subject was prematurely discontinued from TDE-PH-310 for reasons other than a clinical worsening event.
* The subject developed a concurrent illness or condition during the conduct of TDE-PH-310 which, in the opinion of the Investigator, would represent a risk to their overall health if they enrolled in this study.
18 Years
75 Years
ALL
No
Sponsors
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United Therapeutics
INDUSTRY
Responsible Party
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Locations
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Arizona Pulmonary Specialists, Ltd.
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
University of California, San Francisco-Fresno
Fresno, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California-Davis Medical Group, Advanced Lung Disease/Transplant Program
Sacramento, California, United States
David Geffen School of Medicine
Torrance, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
University of Florida
Gainesville, Florida, United States
University of Florida College of Medicine Jacksonville- Division of Pulmonary & Critical Medicine
Jacksonville, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
Piedmont - Georgia Lung Associates
Austell, Georgia, United States
HeartCare Midwest
Peoria, Illinois, United States
Indiana University Hospital
Carmel, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Kentuckiana Pulmonary Associates
Louisville, Kentucky, United States
University of Maryland
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Beaumont Health
Troy, Michigan, United States
Nebraska Medical Center
Omaha, Nebraska, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
University of Rochester
Rochester, New York, United States
Asheville Cardiology Associates
Asheville, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
University Hospital
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Legacy Research Institute
Portland, Oregon, United States
Perelman Center for Advanced Medicine, University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center - Presbyterian Cardiovascular Institute
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Sanatorio San José
CABA, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Distrito Federal, Argentina
Hospital Italiano Garibaldi
Rosario, Santa Fe Province, Argentina
Sanatorio de la Trinidad Mitre
Buenos Aires, , Argentina
Hospital Dr. José María Cullen
Santa Fe, , Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Nepean Hospital
Kingswood, New South Wales, Australia
Saint Vincents Hospital
Sydney, New South Wales, Australia
Macquarie University
Sydney, New South Wales, Australia
Prince Charles Hospital
Chermside, Queensland, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Krankenhaus Elisabethinen Linz
Linz, Upper Austria, Austria
Medizinische Universität Wien
Vienna, , Austria
Hospital das Clinicas da Universidade Federal de Goias
Goiânia, Goiás, Brazil
Hospital das Clínicas da Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
Hospital Madre Teresa
Belo Horizonte, Minas Gerais, Brazil
Complexo Hospitalar Santa Casa de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital das Clínicas da Faculdade de Medicina de Botucatu- UNESP
Botucatu, São Paulo, Brazil
Hospital da Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
Escola Paulista de Medicina, Universidade Federal de São Paulo
São Paulo, São Paulo, Brazil
Hospital Alemão Oswaldo Cruz
São Paulo, , Brazil
Respiratory Research Foundation
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Vancouver Coastal Health
Vancouver, British Columbia, Canada
Lawson Health Research Institute
London, Ontario, Canada
Centro de Investigaciones TASOL
Santiago, Santiago Metropolitan, Chile
Clínica Tabancura
Vitacura, Santiago Metropolitan, Chile
Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, China
Guangdong General Hospital
Guangzhou, Guangdong, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, China
Xiangya Hospital
Changsha, Hunan, China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanchang Medical University
Nanchang, Jiangxi, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
West China Hospital
Chengdu, Sichuan, China
Peking Union Medical College Hospital
Beijing, , China
Beijing Shijitan Hospital
Beijing, , China
Chinese PLA General Hospital
Beijing, , China
The Affiliated Hospital of Qingdao University
Qingdao, , China
Renji Hospital of Shanghai Jiaotong University
Shanghai, , China
Shanghai Pulmonary Hospital of Tongji University
Shanghai, , China
Shenyang General Hospital of Shenyang Military Command
Shenyang, , China
Aarhus Universitetshospital, Skejby
Aarhus, , Denmark
Rigshospitalet-Copenhagen University Hospital
Copenhagen, , Denmark
Hopital Haut-Leveque, CHU Bordeaux
Pessac, Aquitaine, France
Hopital Jean Minjoz Centre Hospitalier Universitaire Besancon
Besançon, Franche-comte, France
Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
Lille, Hauts-de-France, France
CHU de Montpellier
Montpellier, Languedoc-roussillon, France
Hopital Brabois
Vandœuvre-lès-Nancy, Limousin, Lorraine, France
Centre Hospitalier Universitaire Hopital Nord
Marseille, Provence-Alpes-Côte d'Azur Region, France
Thoraxklinik am Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Ludwig-Maximilians-Universitat Munchen
München, Bavaria, Germany
Universitätsklinikum Regensburg
Regensburg, Bavaria, Germany
Missionsarztliche Klinik Wurzburg gGmbH
Würzburg, Bavaria, Germany
Universitätsmedizin Greifswald
Greifswald, Mecklenburg-Vorpommern, Germany
Bergmannsheil Berufsgenossenschaftliche Universitätsklinik GmbH
Bochum, North Rhine-Westphalia, Germany
Universitätsklinikum Köln
Cologne, North Rhine-Westphalia, Germany
Herzzentrum Duisburg
Duisburg, North Rhine-Westphalia, Germany
Universitätsmedizin der Johannes Gutenberg Universität
Mainz, Rhineland-Palatinate, Germany
Universitätsklinikum des Saarlandes
Homburg, Saarland, Germany
Technische Universität Dresden
Dresden, Saxony, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany
Universitätskrankenhaus Hamburg-Eppendorf
Hamburg, , Germany
University General Hospital of Attikon
Athens, Attica, Greece
General Hospital of Thessaloniki, "G.Papanikolaou"
Thessaloniki, Macedoni, Greece
CARE Hospital
Hyderabad, Andhra Pradesh, India
Mediciti Hospital
Hyderabad, Andhra Pradesh, India
Care Institute Medical Sciences
Ahmedabad, Gujarat, India
Apollo Hospitals International, Ltd.
Gandhinagar, Gujarat, India
Medanta - The Medicity
Gurgaon, Haryana, India
Narayana Institute of Cardiac Sciences
Bangalore, Karnataka, India
KEM Hospital
Mumbai, Maharashtra, India
King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College
Mumbai, Maharashtra, India
Ruby Hall Clinic
Pune, Maharashtra, India
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, India
Indraprastha Apollo Hospital
New Delhi, National Capital Territory of Delhi, India
Apollo Hospital
Chennai, Tamil Nadu, India
G. Kuppuswamy Naidu Memorial Hospital
Coimbatore, Tamil Nadu, India
Rabin Medical Center
Petach Tikvah, Petah Tiqwa, Israel
The Chaim Sheba Medical Center at Tel Hashomer
Tel Litwinsky, Tel Aviv, Israel
Rambam Health Corp.
Haifa, , Israel
Carmel Medical Center
Haifa, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Azienda Ospedaliera Universitaria
Napoli, , Italy
Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)
Palermo, , Italy
Fondazione IRCCS Policlinico S. Matteo
Pavia, , Italy
Azienda Policlinico Umberto I di Roma
Roma, , Italy
Instituto Nacional de Cardiologia Ignacio Chavez
Tlalpan, Mexico City, Mexico
Unidad de Investigacion Clinica en Medicina S.C.
Monterrey, Nuevo León, Mexico
Universitair Medisch Centrum Sint Radboud
Nijmegen, Gelderland, Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam, North Holland, Netherlands
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, , Poland
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K. Marcinkowskiego w Poznaniu
Krakow, , Poland
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Małogoskie, , Poland
Europejskie Centrum Zdrowia Otwock, Szpital im. Fryderyka Chopina
Otwock, , Poland
National University Hospital
Singapore, , Singapore
National Heart Centre Singapore
Singapore, , Singapore
Gachon University Gil Medical Center
Incheon, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden
Karolinska University Hospital Solna
Stockholm, , Sweden
National Cheng Kung University Hospital
Tainan City, Tainan CITY, Taiwan
Veterans General Hospital-Kaohsiung
Kaohsiung City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Papworth Hospital
Papworth Everard, Cambridgshire, United Kingdom
Royal Free Hospital
London, England, United Kingdom
Freeman Hospital
Newcastle upon Tyne, England, United Kingdom
Royal Hallamshire Hospital
Sheffield, England, United Kingdom
Countries
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References
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Grunig E, Rahaghi F, Elwing J, Vizza CD, Pepke-Zaba J, Shen J, Yao H, Hage A, Rosenkranz S, Vonk M, Balasubramanian V, Yuanhua Y, Yu Z, Lordan J, Cadaret L, Grover R, Ousmanou A, Seaman S, Deng C, Broderick M, White RJ; FREEDOM-EV Investigators. Oral Treprostinil is Associated with Improved Survival in FREEDOM-EV and its Open-Label Extension. Adv Ther. 2024 Feb;41(2):618-637. doi: 10.1007/s12325-023-02711-x. Epub 2023 Dec 6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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TDE-PH-311
Identifier Type: -
Identifier Source: org_study_id
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