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

This study is currently recruiting participants.
Verified April 2014 by United Therapeutics
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01560637
First received: March 9, 2012
Last updated: April 15, 2014
Last verified: April 2014
  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: 858
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
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
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 Recruiting
Tucson, Arizona, United States, 85724
Contact: Oscar Furet    520-626-8112      
Principal Investigator: Franz Rischard         
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 Recruiting
Torrance, California, United States, 90502
Contact: Joy Beckman    310-222-3560      
Principal Investigator: Ronald Oudiz, MD         
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
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 Recruiting
Atlanta, Georgia, United States, 30322
Contact: Megan Filkowski    404-712-7458      
Principal Investigator: Micah Fisher, MD         
United States, Illinois
HeartCare Midwest Recruiting
Peoria, Illinois, United States, 61614
Contact: Rita Klundt    309-691-4410      
Principal Investigator: Ron Oren, MD         
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 55242
Contact: Cynthia Larew    319-353-7953      
Principal Investigator: Sif Hansdottir, 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 Recruiting
Baltimore, Maryland, United States, 21201
Contact: Myung Park, MD    410-328-7260      
Principal Investigator: Myung Park         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Laurie Lawler    617-525-9731      
Principal Investigator: Aaron Waxman, MD, PhD         
United States, Nebraska
Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-5990
Contact: Traci Nelson    402-559-7585      
Principal Investigator: Austin Thompson, MD         
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, 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         
United States, Pennsylvania
Perelman Center for Advanced Medicine, University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Faith Pickering    215-662-4214      
Principal Investigator: J. Eduardo Rame, MD         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Barbara Smithson    401-444-9097      
Principal Investigator: James Klinger, MD         
United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Kristi Morin    713-500-6851      
Principal Investigator: Bela Patel, MD         
United States, Virginia
Sentara Cardiovascular Research Institute Recruiting
Norfolk, Virginia, United States, 23507
Contact: Melinda Bullivant    757-388-4024      
Principal Investigator: Michael Eggert, MD         
United States, Wisconsin
Aurora Saint Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Paulette Schauer    414-649-5664      
Principal Investigator: Dianne Zwicke, MD         
Australia, New South Wales
Royal Prince Alfred Hospital Recruiting
Camperdown, New South Wales, Australia, 2050
Contact: Dorothy Fowler    +61295159371      
Principal Investigator: Peter Youssef         
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         
Australia, Queensland
Prince Charles Hospital Recruiting
Chermside, Queensland, Australia, 4032
Contact: Paula Ve    610731395159      
Principal Investigator: Fiona Kermeen         
Australia, Victoria
The Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Christianne Manterfield    61392762489      
Principal Investigator: Trevor Williams         
Royal Melbourne Hospital Recruiting
Parkville, Victoria, Australia, 3050
Contact: Sue Schulz    393428490      
Principal Investigator: David Smallwood         
Austria
Medizinische Universität Wien Recruiting
Wien, Austria, 1090
Contact: Gerlinde Freistetter    +431404006216      
Principal Investigator: Irene Lang         
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         
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: Zaixing 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 Recruiting
Nanchang, Jiangxi, China, 330006
Contact: Julan Hu       julanhu@126.dom   
Principal Investigator: Xiaoshu Cheng         
China, Sichuan
West China Hospital Recruiting
Chengdu, Sichuan, China, 610047
Contact: He Huang    18980601867      
Principal Investigator: Qun Yi         
China
Chinese PLA General Hospital Recruiting
Beijing, China, 100853
Contact: Xiangzhu Dong    +86 13810390323      
Principal Investigator: Yundai Chen         
Beijing Shijitan Hospital Recruiting
Beijing, China, 100038
Contact: Jingyi Zhang       Bao872601@126.com   
Principal Investigator: Lei Pan         
Peking Union Medical College Hospital Recruiting
Beijing, China, 100005
Contact: Guozhen Li    13810060553      
Principal Investigator: Su Yang Zhang         
Shanghai Pulmonary Hospital of Tongji University Recruiting
Shanghai, China, 200433
Contact: Jing Yao       yaojingbaobao@126.com   
Principal Investigator: Jinming Liu         
Renji Hospital of Shanghai Jiaotong University Recruiting
Shanghai, China, 200001
Contact: Jie Chen       cismile321@hotmail.com   
Principal Investigator: Chunde Bao         
Shenyang General Hospital of Shenyang Military Command Recruiting
Shenyang, China, 110015
Contact: Yuxia Wang    +86 139 4046 2016      
Principal Investigator: Xianyang Zhu         
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 Recruiting
Montpellier cedex 5, Languedoc-roussillon, France, 34295
Contact: Isabella Vachier    +33467042020      
Principal Investigator: Arnaud Bourdin         
Hopital Brabois Recruiting
Vandoeuvre-Les-Nancy, Limousin, Lorraine, France, 54500
Contact: Agnes Didier    +33383153235      
Principal Investigator: Ari Chaouat         
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 Recruiting
Munchen, Bayern, Germany, 81377
Contact: Franziska Ihle    498970953090      
Principal Investigator: Claus Neurohr         
Universitätsklinikum Regensburg Recruiting
Regensburg, Bayern, Germany, 93053
Contact: Elke Heinz    499419447281      
Principal Investigator: Tobias Lange, Dr.         
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         
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         
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: Pnina Yaron    +97235302328      
Principal Investigator: Issahar Ben-Dov         
Carmel Medical Center Recruiting
Haifa, Israel, 34362
Contact: Amer Ubied    +97248250515      
Principal Investigator: Yochai Adir         
Rambam Health Corp. Recruiting
Haifa, Israel, 31096
Contact: Iris Marom    +97248542650      
Principal Investigator: Mordechai Yigla         
Hadassah Medical Center Recruiting
Jerusalem, Israel, 91120
Contact: Elat Bardach    972507874654      
Principal Investigator: Neville Berkman         
Italy
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
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         
Mexico
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         
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 Recruiting
Sheffield, England, United Kingdom, S10 2JF
Contact: Kathryn Birchall    4401142713339      
Principal Investigator: David Kiely         
Sponsors and Collaborators
United Therapeutics
  More Information

No publications provided

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: April 15, 2014
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, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Treprostinil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014