Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by United Therapeutics
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01560637
First received: March 9, 2012
Last updated: November 15, 2016
Last verified: November 2016
  Purpose
This study is an international, multi-center, open-label study designed to provide oral treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have completed the TDE-PH-310 study. The purpose of this study is to assess the long-term safety of UT-15C and to assess the effects of long-term treatment with UT-15C on exercise capacity.

Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: UT-15C (treprostinil diethanolamine)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Extension Study of UT-15C in Subjects With Pulmonary Arterial Hypertension- A Long-Term Follow-Up to Protocol TDE-PH-310

Resource links provided by NLM:


Further study details as provided by United Therapeutics:

Primary Outcome Measures:
  • Safety (e.g.number and frequency of adverse events, changes in laboratory parameters from Baseline) [ Time Frame: participants will be followed every 12 weeks, at minimum, until they discontinue the study or the study is discontinued by the sponsor or for a period up to 2.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 850
Study Start Date: May 2012
Estimated Study Completion Date: August 2021
Estimated Primary Completion Date: May 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: UT-15C
Open label access
Drug: UT-15C (treprostinil diethanolamine)
UT-15C sustained release oral tablet for three times daily administration

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participated in United Therapeutics Study TDE-PH-310

Exclusion Criteria:

  • Premature discontinuation of United Therapeutics Study TDE-PH-310 due to reasons other than clinical worsening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01560637

  Hide Study Locations
Locations
United States, Arizona
Arizona Pulmonary Specialists, Ltd. Recruiting
Phoenix, Arizona, United States, 85012
Contact: Lorraine Stroud    602-271-0832      
Principal Investigator: Jeremy Feldman, MD         
University of Arizona Terminated
Tucson, Arizona, United States, 85724
United States, California
University of California, San Francisco-Fresno Recruiting
Fresno, California, United States, 93701
Contact: Sonia Garcia    559-459-4042      
Principal Investigator: Vijay Balasubramanian, MD         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90211
Contact: Lucilla Garcia    310-248-7134      
Principal Investigator: Antoine Hage         
University of California-Davis Medical Group, Advanced Lung Disease/Transplant Program Recruiting
Sacramento, California, United States, 95817
Contact: Macey Sockolov    916-734-1554      
Principal Investigator: Roblee Allen, MD         
David Geffen School of Medicine Completed
Torrance, California, United States, 90502
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: David Badesch, MD    303-315-1805      
Principal Investigator: David Badesch, MD         
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Chris Eagan    352-273-8990      
Principal Investigator: Hassan Alnuaimat         
University of Florida College of Medicine Jacksonville- Division of Pulmonary & Critical Medicine Recruiting
Jacksonville, Florida, United States, 32209
Contact: Minal Patel    904-244-1106      
Principal Investigator: Abubakr Bajwa         
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
Contact: Norma Jean Barton    954-659-6213      
Principal Investigator: Franck Rahaghi, MD         
United States, Georgia
Emory University Hospital Completed
Atlanta, Georgia, United States, 30322
Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Tanya Mims    706-721-9680    TAMIMS@augusta.edu   
Principal Investigator: Clark McDonough, MD         
Piedmont - Georgia Lung Associates Recruiting
Austell, Georgia, United States, 30106
Contact: Stacy Beasley    404-605-2986      
Principal Investigator: Chad Miller         
United States, Illinois
HeartCare Midwest Completed
Peoria, Illinois, United States, 61614
United States, Indiana
Indiana University Hospital Completed
Carmel, Indiana, United States, 46032
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 55242
Contact: Cynthia Larew    319-353-7953      
Principal Investigator: Linda Cadaret, MD         
United States, Kentucky
Kentuckiana Pulmonary Associates Recruiting
Louisville, Kentucky, United States, 40202
Contact: Kimberly Robinson    502-587-8000      
Principal Investigator: John McConnell, MD         
United States, Maryland
University of Maryland Completed
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Tufts Medical Center Completed
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Laurie Lawler    617-525-9731      
Principal Investigator: Aaron Waxman, MD, PhD         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Jacqueline Day    313-916-1254      
Principal Investigator: Rana Awdish, M.D.         
Beaumont Health Completed
Troy, Michigan, United States, 48085
United States, Nebraska
Nebraska Medical Center Completed
Omaha, Nebraska, United States, 68198-5990
United States, New Jersey
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
Contact: Juliet Williams    973-926-8578      
Principal Investigator: Christina Migliore, MD         
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Karen Frutiger    585-486-0869      
Principal Investigator: R. James White, M.D., Ph.D.         
United States, North Carolina
Asheville Cardiology Associates Completed
Asheville, North Carolina, United States, 28803
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Tammy Roads    513-558-2148      
Principal Investigator: Jean Elwing, MD         
University Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: David Haney    216-844-2381      
Principal Investigator: Robert Schilz, DO, PhD         
Ohio State University Recruiting
Columbus, Ohio, United States, 43321
Contact: Melissa Michetti    614-366-2761      
Principal Investigator: Namita Sood, MD         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97201-3098
Contact: Nathan Kessler    503-494-9570      
Principal Investigator: Akram Khan, MD         
Legacy Research Institute Completed
Portland, Oregon, United States, 97210
United States, Pennsylvania
Perelman Center for Advanced Medicine, University of Pennsylvania Completed
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center - Presbyterian Cardiovascular Institute Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Kristin Shoemaker    412-647-6000      
Principal Investigator: Michael Mathier, MD         
United States, Rhode Island
Rhode Island Hospital Completed
Providence, Rhode Island, United States, 02903
United States, Texas
The University of Texas Health Science Center at Houston Completed
Houston, Texas, United States, 77030
United States, Virginia
Sentara Cardiovascular Research Institute Recruiting
Norfolk, Virginia, United States, 23507
Contact: Melinda Bullivant    757-388-4024      
Principal Investigator: Michael Eggert, MD         
Virginia Commonwealth University Completed
Richmond, Virginia, United States, 23298
United States, Wisconsin
Aurora Saint Luke's Medical Center Completed
Milwaukee, Wisconsin, United States, 53215
Argentina
Sanatorio San José Recruiting
Caba, Buenos Aires, Argentina, C1425DUH
Contact: Adrian Lescano    541148222748      
Principal Investigator: Adrian Lescano, MD         
Hospital Italiano de Buenos Aires Completed
Ciudad Autónoma de Buenos Aires, Distrito Federal, Argentina, C1181ACH
Hospital Italiano Garibaldi Completed
Rosario, Santa Fe, Argentina, S2001OAD
Sanatorio de la Trinidad Mitre Completed
Buenos Aires, Argentina
Hospital Dr. José María Cullen Recruiting
Santa Fe, Argentina, S3000EOY
Contact: Cristian Botta    +543424835032      
Principal Investigator: Cristian Botta, MD         
Australia, New South Wales
Royal Prince Alfred Hospital Completed
Camperdown, New South Wales, Australia, 2050
Nepean Hospital Recruiting
Kingswood, New South Wales, Australia, 2751
Contact: Michele Mackenzie    +61247343068      
Principal Investigator: Benjamin Ng         
Saint Vincents Hospital Recruiting
Sydney, New South Wales, Australia, 2010
Contact: Karen Brown    61283823723      
Principal Investigator: Anne Keogh         
Macquarie University Recruiting
Sydney, New South Wales, Australia, 2109
Contact: Radhika Butala    +61298123561      
Principal Investigator: Martin Brown         
Australia, Queensland
Prince Charles Hospital Completed
Chermside, Queensland, Australia, 4032
Australia, Tasmania
Royal Hobart Hospital Recruiting
Hobart, Tasmania, Australia, 7000
Contact: Jane Mitchell    61362228620      
Principal Investigator: Nathan Dwyer, MD         
Australia, Victoria
The Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Christianne Manterfield    61392762489      
Principal Investigator: Trevor Williams         
Royal Melbourne Hospital Completed
Parkville, Victoria, Australia, 3050
Austria
Krankenhaus Elisabethinen Linz Recruiting
Linz, Upper Austria, Austria, 4020
Contact: Sabine Metz    4373276764414      
Principal Investigator: Regina Steringer-Mascherbauer, MD         
Medizinische Universität Wien Recruiting
Wien, Austria, 1090
Contact: Gerlinde Freistetter    +431404006216      
Principal Investigator: Irene Lang         
Brazil
Hospital das Clinicas da Universidade Federal de Goias Completed
Goiania, Goias, Brazil, 74605-050
Hospital das Clínicas da Universidade Federal de Minas Gerais Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30130-100
Contact: Josyene Simão    553134099255      
Principal Investigator: Ricardo Corrêa, MD         
Hospital Madre Teresa Completed
Belo Horizonte, Minas Gerais, Brazil, 30380-090
Complexo Hospitalar Santa Casa de Porto Alegre Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
Contact: Francine de Souza Dalpian    +555132137068      
Principal Investigator: Gisela Meyer         
Hospital das Clínicas da Faculdade de Medicina de Botucatu- UNESP Completed
Botucatu, Sao Paulo, Brazil, 18618-970
Hospital da Clínicas da Faculdade de Medicina da Universidade de São Paulo Recruiting
São Paulo, Sao Paulo, Brazil, 05403-000
Contact: Raquel de Campos da Silva    551126615961      
Principal Investigator: Rogério de Souza, MD         
Escola Paulista de Medicina, Universidade Federal de São Paulo Recruiting
São Paulo, Sao Paulo, Brazil
Contact: Priscilla Figueiredo    551155764238      
Principal Investigator: Jaquelina Ota Arakaki, MD         
Hospital Alemão Oswaldo Cruz Recruiting
São Paulo, Brazil, 01323-020
Contact: Priscila Kazue Kunitake    551135490392      
Principal Investigator: Mônica Silveira Lapa         
Canada, Alberta
Respiratory Research Foundation Recruiting
Calgary, Alberta, Canada, T1Y 6J4
Contact: Naushad Hirani, MD    1 (403) 943-4833      
Principal Investigator: Naushad Hirani, MD         
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Linda Webster    1 (780) 407-8994      
Principal Investigator: Evangelos Michelakis         
Canada, British Columbia
Vancouver Coastal Health Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Lena Legkaia    1 (604) 875-4111 ext 69831      
Principal Investigator: John Swiston, MD         
Canada, Ontario
Lawson Health Research Institute Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Vinolia Arthur-Hayward    1 (519) 685-8500 ext 76528      
Principal Investigator: Sanjay Mehta, MD         
Chile
Centro de Investigaciones TASOL Completed
Santiago, Region Metropolitana, Chile, 7500710
Clínica Tabancura Recruiting
Vitacura, Santiago, Chile, 7650018
Contact: Loreto Perez    562223954364      
Principal Investigator: Pablo Andres Sepulveda Varela, MD         
China, Beijing
Beijing Chao-Yang Hospital Recruiting
Beijing, Beijing, China, 100020
Contact: Yu Zhang    861085231437      
Principal Investigator: Yuanhua Yang         
China, Guangdong
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Danling Zhong    8613710512092      
Principal Investigator: Hua Yao, MD         
China, Hubei
Wuhan Asia Heart Hospital Recruiting
Wuhan, Hubei, China, 430022
Contact: Yun Li       liyunbangbang@sina.cn   
Principal Investigator: Gangcheng Zhang         
China, Hunan
Xiangya Hospital Recruiting
Changsha, Hunan, China, 410008
Contact: Guiyuan Deng    13574827779      
Principal Investigator: Zaixin Yu         
China, Jiangsu
The First Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Yanli Zhou       1634214542@qq.com   
Principal Investigator: Xinli Li         
China, Jiangxi
The Second Affiliated Hospital of Nanchang Medical University Completed
Nanchang, Jiangxi, China, 330006
China, Shanghai
Zhongshan Hospital Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Xiaoxin Chang    862164223006      
Principal Investigator: Daxin Zhou         
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200120
Contact: Jieyan Shen    8613701864819      
Principal Investigator: Jieyan Shen, MD         
China, Sichuan
West China Hospital Recruiting
Chengdu, Sichuan, China, 610047
Contact: He Huang    18980601867      
Principal Investigator: Qun Yi         
China
Peking Union Medical College Hospital Recruiting
Beijing, China, 100005
Contact: Guozhen Li    13810060553      
Principal Investigator: Su Yang Zhang         
Beijing Shijitan Hospital Recruiting
Beijing, China, 100038
Contact: Jingyi Zhang       Bao872601@126.com   
Principal Investigator: Lei Pan         
Chinese PLA General Hospital Recruiting
Beijing, China, 100853
Contact: Xiangzhu Dong    +86 13810390323      
Principal Investigator: Yundai Chen         
The Affiliated Hospital of Qingdao University Recruiting
Qingdao, China, 26603
Contact: Lihong Sun       sun_lihong@wuxiapptec.com   
Contact: Tiffany Gao       Gao.Tiffany@praintl.com   
Principal Investigator: Zhaozhong Cheng         
Renji Hospital of Shanghai Jiaotong University Recruiting
Shanghai, China, 200001
Contact: Jie Chen       cismile321@hotmail.com   
Principal Investigator: Chunde Bao         
Shanghai Pulmonary Hospital of Tongji University Recruiting
Shanghai, China, 200433
Contact: Jing Yao       yaojingbaobao@126.com   
Principal Investigator: Jinming Liu         
Shenyang General Hospital of Shenyang Military Command Recruiting
Shenyang, China, 110015
Contact: Yuxia Wang    +86 139 4046 2016      
Principal Investigator: Xianyang Zhu         
Denmark
Aarhus Universitetshospital, Skejby Recruiting
Aarhus, Denmark, 8200
Contact: Dorte Frydendahl Bjerre    +4578452125    dortemoe@rm.dk   
Principal Investigator: Jens Erik Nielsen-Kudsk         
Rigshospitalet-Copenhagen University Hospital Recruiting
Copenhagen, Denmark, 2100
Contact: Elsebet Eriksen    4535451195      
Principal Investigator: Jørn Carlsen, MD         
France
Hopital Haut-Leveque, CHU Bordeaux Recruiting
Pessac, Aquitaine, France, 33064
Contact: Virginie Hulot    +33557656717      
Principal Investigator: Claire Dromer         
Hopital Jean Minjoz Centre Hospitalier Universitaire Besancon Recruiting
Besancon, Franche-comte, France, 25030
Contact: Agnes Tournier    +0381669460      
Principal Investigator: Marie-France Seronde         
CHU de Montpellier Completed
Montpellier cedex 5, Languedoc-roussillon, France, 34295
Hopital Brabois Completed
Vandoeuvre-Les-Nancy, Limousin, Lorraine, France, 54500
Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez Recruiting
Lille, Nord Pas-de-calais, France, 59037
Contact: Amandine Verhaeghe    33320445048      
Principal Investigator: Eric Hachulla         
Centre Hospitalier Universitaire Hopital Nord Recruiting
Marseille, Provence Alpes Cote D'azur, France, 13015
Contact: Manel Yahyaoui    +330491366137      
Principal Investigator: Martine Reynaud-Gaubert         
Germany
Thoraxklinik am Universitätsklinikum Heidelberg Recruiting
Heidelberg, Baden-wuerttemberg, Germany, 69126
Contact: Nicola Ehlken    4962213968053      
Principal Investigator: Ekkehard Grünig, Prof. Dr.         
Ludwig-Maximilians-Universitat Munchen Completed
Munchen, Bayern, Germany, 81377
Universitätsklinikum Regensburg Recruiting
Regensburg, Bayern, Germany, 93053
Contact: Elke Heinz    499419447281      
Principal Investigator: Tobias Lange, Dr.         
Missionsarztliche Klinik Wurzburg gGmbH Recruiting
Wurzburg, Bayern, Germany, 97074
Contact: Matthias Held, MD       matthias.held@missioklinik.de   
Principal Investigator: Matthias Held, MD         
Universitätsmedizin Greifswald Recruiting
Greifswald, Mecklenburg-vorpommern, Germany, 17475
Contact: Claudia Pohl    493834867262      
Principal Investigator: Ralf Ewert, Dr. Med         
Bergmannsheil Berufsgenossenschaftliche Universitätsklinik GmbH Recruiting
Bochum, Nordrhein-westfalen, Germany, 44789
Contact: Erna Brandenburger    +02343023335      
Principal Investigator: Andrea Koch         
Herzzentrum Duisburg Recruiting
Duisburg, Nordrhein-westfalen, Germany, 47137
Contact: Dunja Schulenburg    +492034513240      
Principal Investigator: Ulrich Krüger         
Universitätsklinikum Köln Recruiting
Köln, Nordrhein-westfalen, Germany, 50937
Contact: Susanne Rölle-Höhne    4922147832356      
Principal Investigator: Stephan Rosenkranz, Dr.         
Universitätsmedizin der Johannes Gutenberg Universität Recruiting
Mainz, Rheinland-pfalz, Germany, 55131
Contact: Brunhilde Fischer    +496131178386      
Principal Investigator: Stavros Konstantinides         
Universitätsklinikum des Saarlandes Recruiting
Homburg, Saarland, Germany, 66424
Contact: Marion Sollgan    004968411623676      
Principal Investigator: Heinrike Wilkens         
Technische Universität Dresden Recruiting
Dresden, Sachsen, Germany, 01307
Contact: Diana Jäkel    4903517965624      
Principal Investigator: Gert Höffken         
Universitätsklinikum Leipzig Recruiting
Leipzig, Sachsen, Germany, 04103
Contact: Patricia Berger    00493419712674      
Principal Investigator: Hubert Wirtz, Dr. Med         
Universitätskrankenhaus Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Ute Dickschas    4940741052990      
Principal Investigator: Hans Klose         
Greece
University General Hospital of Attikon Recruiting
Athens, Attica, Greece, 12462
Contact: Stylianos Orfanos    302105832177      
Principal Investigator: Stylianos Orfanos, MD         
General Hospital of Thessaloniki, "G.Papanikolaou" Recruiting
Thessaloniki, Macedoni, Greece, 57010
Contact: Paraskevi Argyropoulou-Pataka    302313307339      
Principal Investigator: Paraskevi Argyropoulou-Pataka, MD         
India
CARE Hospital Recruiting
Hyderabad, Andhra Pradesh, India, 500 001
Contact: Anurag Shukla    919390651564      
Principal Investigator: B. K. Srinivasa Sastry, MD         
Mediciti Hospital Recruiting
Hyderabad, Andhra Pradesh, India, 500 063
Contact: Padma Kumar Edla Arjun    919848022747      
Principal Investigator: Padma Kumar Edla Arjun, MD         
Sir Ganga Ram Hospital Recruiting
New Delhi, Delhi, India, 110060
Contact: Somya Duhan    919873983874      
Principal Investigator: Jitendra Sawhney, MD         
Indraprastha Apollo Hospital Recruiting
New Delhi, Delhi, India, 110076
Contact: Sahdeep Tripathi    919654314403      
Principal Investigator: Rajeeve Rajput, MD         
Care Institute Medical Sciences Recruiting
Ahmedabad, Gujarat, India, 38006
Contact: Dipal Modi    917930101166      
Principal Investigator: Hemang Baxi, MD         
Apollo Hospitals International, Ltd. Recruiting
Gandhinagar, Gujarat, India, 382428
Contact: Mary Iby    9107966701876      
Principal Investigator: Subir Ghosh         
Medanta - The Medicity Recruiting
Gurgaon, Haryana, India, 122 001
Contact: Arun Rawat    918447871130      
Principal Investigator: Vijay Chopra, MD         
Narayana Institute of Cardiac Sciences Recruiting
Bangalore, Karnataka, India, 560 099
Contact: Ranjani Puttaswamy    918027835208      
Principal Investigator: Suresh Pujar Venkateshacharya         
KEM Hospital Recruiting
Mumbai, Maharashtra, India, 400012
Contact: Rashika Belose    912224107595      
Principal Investigator: Prafulla Kerkar         
Ruby Hall Clinic Recruiting
Pune, Maharashtra, India, 411 001
Contact: Reshma Pawar    919405868870      
Principal Investigator: Shirish Hiremath, MD         
Apollo Hospital Recruiting
Chennai, Tamil Nadu, India, 600006
Contact: Devyani Goel    914428295045      
Principal Investigator: Abraham Oomman, MD         
G. Kuppuswamy Naidu Memorial Hospital Recruiting
Coimbatore, Tamil Nadu, India, 641037
Contact: Swaidha Sadhiq    919791508740      
Principal Investigator: Rajpal Abhaichand, MD         
Israel
Rabin Medical Center Recruiting
Petach Tikvah, Petah Tiqwa, Israel, 49100
Contact: Anat Nachmias Riklis    972546229402      
Principal Investigator: Mordechai Kramer         
The Chaim Sheba Medical Center at Tel Hashomer Recruiting
Tel Hashomer, Tel Aviv, Israel, 52621
Contact: Ariela Velner    97235302841      
Principal Investigator: Michael Segel         
Rambam Health Corp. Completed
Haifa, Israel, 31096
Carmel Medical Center Recruiting
Haifa, Israel, 34362
Contact: Amer Ubied    +97248250515      
Principal Investigator: Yochai Adir         
Hadassah Medical Center Recruiting
Jerusalem, Israel, 91120
Contact: Elat Bardach    972507874654      
Principal Investigator: Neville Berkman         
Italy
Azienda Ospedaliera Universitaria Recruiting
Napoli, Italy
Contact: Anna Correra    393403081408      
Principal Investigator: Michele D'Alto         
Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT) Recruiting
Palermo, Italy, 90127
Contact: Lavinia Martino    390912192489      
Principal Investigator: Patrizio Vitulo, MD         
Fondazione IRCCS Policlinico S. Matteo Recruiting
Pavia, Italy, 27100
Contact: Marta M    390382501326      
Principal Investigator: Laura Scelsi         
Azienda Policlinico Umberto I di Roma Recruiting
Roma, Italy, 00161
Contact: Martina Nocioni    390649979016      
Principal Investigator: Carmine Dario Vizza         
Korea, Republic of
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of, 405-760
Contact: Jeong-Won Cho    82324603648      
Principal Investigator: Wook-Jin Chung         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Sun Hui Lee    82220724034      
Principal Investigator: Hyung-Kwan Kim         
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Kyung Jin An    82222288304      
Principal Investigator: Hyuk-Jae Chang         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Sojeong Jeon    82234101698      
Principal Investigator: Sung-A Chang         
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Young Suk Kim    82230103168      
Principal Investigator: Jong-Min Song         
Mexico
Instituto Nacional de Cardiologia Ignacio Chavez Recruiting
Tlalpan, Distrito Federal, Mexico, 14080
Contact: Maria Teresa Miranda Kirchner    5255557329111350      
Principal Investigator: Tomas Pulido         
Unidad de Investigacion Clinica en Medicina S.C. Recruiting
Monterrey, Nuevo Leon, Mexico, 64718
Contact: Gerardo Andres Ortiz Lopez    +52818146076103      
Principal Investigator: Carlos Jerjes-Sanchez         
Netherlands
Universitair Medisch Centrum Sint Radboud Recruiting
Nijmegen, Gelderland, Netherlands, 6525 GA
Contact: Sjoukje Mulder    31243619398      
Principal Investigator: Madelon Vonk         
Vrije Universiteit Medisch Centrum Recruiting
Amsterdam, Noord-holland, Netherlands, 1081 HV
Contact: Ale Struiksma    31204444912      
Principal Investigator: Anko Boonstra         
Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku Recruiting
Bialystok, Poland, 15276
Contact: Katarzyna Ptaszynska-Kopczynska       kasia.ptaszynska@op.pl   
Principal Investigator: Bozena Sobkowicz         
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K. Marcinkowskiego w Poznaniu Recruiting
Krakow, Poland, 61848
Contact: Anna Smukowska-Gorynia    +48618549146    aniasmuk@wp.pl   
Principal Investigator: Tatiana Mularek-Kubzdela         
Krakowski Szpital Specjalistyczny im. Jana Pawla II Recruiting
Malogoskie, Poland, 31202
Contact: Grzegorz Kopec    +48126142287    gkopec@szpitaljp2.krakow.pl   
Principal Investigator: Piotr Podolec         
Europejskie Centrum Zdrowia Otwock, Szpital im. Fryderyka Chopina Recruiting
Otwock, Poland
Contact: Michal Florczyk       michal.florczyk@ecz-otwock.pl   
Principal Investigator: Adam Torbicki         
Singapore
National University Hospital Recruiting
Singapore, Singapore, 119228
Contact: Geying Li    6567725456      
Principal Investigator: Wei Luen James Yip, MD         
National Heart Centre Singapore Recruiting
Singapore, Singapore, 168 752
Contact: Xiu Qi Aw    6564367620      
Principal Investigator: Soo Teik Lim         
Sweden
Sahlgrenska University Hospital Recruiting
Göteborg, Vastra Gotaland, Sweden, 413 45
Contact: Carola Gustafsson    46313427424      
Principal Investigator: Bengt Rundqvist         
Karolinska University Hospital Solna Recruiting
Stockholm, Sweden, 171 76
Contact: Margitha Dahl       lung-allergiforsksolna@karolinska.se   
Principal Investigator: Magnus Nisell         
Taiwan
National Cheng Kung University Hospital Recruiting
Tainan, Tainan City, Taiwan, 70403
Contact: Tzu-Fei Tsai    88662353535 ext 2388      
Principal Investigator: Chih-Hsin Hsu         
Veterans General Hospital-Kaohsiung Recruiting
Kaohsiung, Taiwan, 81362
Contact: Pin-Yu Pan    +88673422121 ext 8310      
Principal Investigator: Chin-Chang Cheng         
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 40705
Contact: Wan-Jane Tsai    +8864235925253120      
Principal Investigator: Kuo-Yang Wang         
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Contact: Yu-Mei Lai    88622312345665000      
Principal Investigator: Hsao-Hsun Hsu         
United Kingdom
Papworth Hospital Recruiting
Papworth Everard, Cambridgshire, United Kingdom, CB3 8RE
Contact: Joanna Pepke-Zaba, MD    4414808305414220      
Principal Investigator: Joanna Pepke-Zaba, MD         
Royal Free Hospital Recruiting
London, England, United Kingdom, NW3 2QG
Contact: Rachel Ochiel    44207317754434200      
Principal Investigator: Gerry Coghlan         
Freeman Hospital Recruiting
Newcastle upon Tyne, England, United Kingdom, NE7 7DN
Contact: Margaret Day    1912127462      
Principal Investigator: Paul Corris         
Royal Hallamshire Hospital Completed
Sheffield, England, United Kingdom, S10 2JF
Sponsors and Collaborators
United Therapeutics
  More Information

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01560637     History of Changes
Other Study ID Numbers: TDE-PH-311 
Study First Received: March 9, 2012
Last Updated: November 15, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by United Therapeutics:
PAH
PH
FREEDOM
6 minute walk test
treprostinil
open label

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Treprostinil
Antihypertensive Agents

ClinicalTrials.gov processed this record on December 09, 2016