Trial record 2 of 2 for:    TDE-PH-310

Trial of the Early Combination of Oral Treprostinil With Background Oral Monotherapy in Subjects With Pulmonary Arterial Hypertension (FREEDOM-Ev)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by United Therapeutics
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01560624
First received: March 9, 2012
Last updated: May 14, 2015
Last verified: May 2015
  Purpose

This study is an international, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are currently receiving background oral monotherapy for at least 30 days at randomization for their PAH. Study visits will occur in four week intervals for the first 12 weeks, then every 12 weeks thereafter with key measures of efficacy being time to first clinical worsening event and the 6-minute walk test at Week 24. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. Patients who complete all required assessments will also be eligible to enter a long-term, open-label, extension study (TDE-PH-311).


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, International, Multi-Center, Randomized, Double- Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects With Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy

Resource links provided by NLM:


Further study details as provided by United Therapeutics:

Primary Outcome Measures:
  • Change in 6 minute walk distance [ Time Frame: From Baseline to Week 24 ] [ Designated as safety issue: No ]
  • Time to first clinical worsening event [ Time Frame: From randomization to approximately 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 610
Study Start Date: July 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matching placebo (sugar pill)
Drug: Placebo
Placebo (sugar pill) for three times daily oral administration
Active Comparator: Active
Active UT-15C Sustained release tablet
Drug: UT-15C (treprostinil diethanolamine)
UT-15C sustained release oral tablets 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:

  1. Between 18 and 75 years of age, inclusive
  2. PAH that is idiopathic / heritable, PAH associated with connective tissue disease, HIV infection, repaired congenital systemic-to-pulmonary shunts (repaired > 1 year), or appetite suppressant / toxin use
  3. Receiving one PAH-approved oral therapy at an appropriate dose
  4. Previous testing (e.g. right heart catheterization, echocardiography) consistent with diagnosis of PAH

Exclusion Criteria:

  1. Nursing or pregnant
  2. PAH due to conditions other than noted in the above inclusion criteria
  3. History of uncontrolled sleep apnea, severe liver disease, left sided heart disease, uncontrolled systemic hypertension
  4. Use of an investigational drug or device within 30 days of Baseline
  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: NCT01560624

  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, M.D.         
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, 93721
Contact: Sonia Garcia    559-459-4042      
Principal Investigator: Vijay Balasubramanian, M.D.         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90211
Contact: Lucilla Garcia    310-248-7134      
Principal Investigator: Antoine Hage, MD         
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, M.D.         
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: David Badesch, M.D.    303-315-1805      
Principal Investigator: David Badesch, M.D.         
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Chris Eagan    352-273-8990      
Principal Investigator: Hassan Alnuaimat, M.D.         
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
Contact: Norma Jean Barton    954-659-6213      
Principal Investigator: Franck Rahaghi, MD, MHS         
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 Completed
Peoria, Illinois, United States, 61614
United States, Indiana
Indiana University Hospital Recruiting
Carmel, Indiana, United States, 46032
Contact: Debra Broach    317-435-8066      
Principal Investigator: William Harvey, MD         
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 55242
Contact: Cynthia Larew, BSN    319-353-7953      
Principal Investigator: Linda Cadaret, M.D.         
United States, Kentucky
Kentuckiana Pulmonary Associates Recruiting
Louisville, Kentucky, United States, 40202
Contact: Kimberly Robinson    502-587-8000      
Principal Investigator: John McConnell, M.D.         
United States, Maryland
University of Maryland Completed
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Laurie Lawler    617-525-9731      
Principal Investigator: Aaron Waxman, MD, PhD         
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Karen Visnaw, RN    617-636-1334      
Principal Investigator: Nicholas Hill, MD         
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.         
United States, Nebraska
Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-5990
Contact: Traci Nelson    402-559-7585      
Principal Investigator: Austin B 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, North Carolina
Asheville Cardiology Associates Recruiting
Asheville, North Carolina, United States, 28803
Contact: Amber Hull    828-274-6000      
Principal Investigator: Benjamin Trichon, MD         
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267-0564
Contact: Tammy Roads    513-558-2148      
Principal Investigator: Jean Elwing, M.D.         
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, M.D.         
United States, Oregon
Legacy Research Institute Recruiting
Portland, Oregon, United States, 97210
Contact: Tamara Mayfield    503-413-7945      
Principal Investigator: Catherine Markin, MD         
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 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 Recruiting
Providence, Rhode Island, United States, 02903
Contact: Barbara Smithson    401-444-9097      
Principal Investigator: James Klinger, M.D.         
United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Kristi Morin, BSN    713-500-6851      
Principal Investigator: Bela Patel, M.D.         
United States, Virginia
Sentara Cardiovascular Research Institute Recruiting
Norfolk, Virginia, United States, 23507
Contact: Melinda Bullivant       mmbulliv@sentara.com   
Principal Investigator: Michael Eggert         
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Amy Frayser       afrayser@vcu.edu   
Principal Investigator: Daniel Grinnan, M.D.         
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         
Argentina
Sanatorio San José Recruiting
Caba, Buenos Aires, Argentina, C1425DUH
Contact: Adrian Lescano, MD    541148222748      
Principal Investigator: Adrian Lescano, MD         
Hospital Italiano de Buenos Aires Recruiting
Ciudad Autónoma de Buenos Aires, Distrito Federal, Argentina, C1181ACH
Contact: Claudia Liliana Dubra    5411495902008487      
Principal Investigator: Graciela Svetliza, MD         
Hospital Italiano Garibaldi Recruiting
Rosario, Santa Fe, Argentina, S2001OAD
Contact: Fabian Diez, MD    +54341485888ext354      
Principal Investigator: Fabian Diez, MD         
Sanatorio de la Trinidad Mitre Recruiting
Buenos Aires, Argentina
Contact: Paola Morara    +5491166378955      
Principal Investigator: Guillermo Bortman, MD         
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 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    +00610731395159      
Principal Investigator: John Feenstra         
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    +0390762743      
Principal Investigator: Trevor Williams         
Royal Melbourne Hospital Completed
Parkville, Victoria, Australia, 3052
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    +00431404006216      
Principal Investigator: Irene Lang         
Brazil
Hospital das Clinicas da Universidade Federal de Goias Recruiting
Goiania, Goias, Brazil, 74605-050
Contact: Arabela Maria Sampaio    556232698294      
Principal Investigator: Maria Auxiliadora Moreira         
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 Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30380-090
Contact: Alessandra Mancuzo    553134099255      
Principal Investigator: Frederico Campos, MD         
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 Recruiting
Botucatu, Sao Paulo, Brazil, 18618-970
Contact: Sueli Santangelo    551438116575      
Principal Investigator: Hugo Hyung Bok Yoo         
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 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         
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, M.D.    1 (403) 943-4833      
Principal Investigator: Naushad Hirani, M.D.         
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Linda Webster, RN    1 (780) 407-8994      
Principal Investigator: Evangelos Michelakis, MD         
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, M.D.         
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, M.D.         
Chile
Centro de Investigaciones TASOL Recruiting
Santiago, Region Metropolitana, Chile, 7500710
Contact: Cecilia Sanchez Ponce    56296791791      
Principal Investigator: Mónica Zagolin         
Clínica Tabancura Recruiting
Vitacura, Santiago, Chile, 7650018
Contact: Loreto Perez    562223954364      
Principal Investigator: Pablo Andres Sepulveda Varela         
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: 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, Shanghai
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200120
Contact: Jieyan Shen, MD    8613701864819      
Principal Investigator: Jieyan Shen, MD         
Zhongshan Hospital Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Xiaoxin Chang    862164223006      
Principal Investigator: Daxin Zhou         
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         
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         
Renji Hospital of Shanghai Jiaotong University Recruiting
Shanghai, China, 200001
Contact: Jie Chen       cjsmile321@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
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 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.         
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    +00492034513240      
Principal Investigator: Ulrich Krüger         
Universitätsklinikum Köln Recruiting
Köln, Nordrhein-westfalen, Germany, 50937
Contact: Susanne Rölle-Höhne    +4922147832356      
Principal Investigator: Stephan Rosenkranz         
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, Dr.         
Greece
University General Hospital of Attikon Recruiting
Athens, Attica, Greece, 12462
Contact: Stylianos Orfanos    302105832177      
Principal Investigator: Stylianos Orfanos         
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         
Indraprastha Apollo Hospital Recruiting
New Delhi, Delhi, India, 110076
Contact: Sahdeep Tripathi    919654314403      
Principal Investigator: Rajeeve Rajput, MD         
Sir Ganga Ram Hospital Recruiting
New Delhi, Delhi, India, 110060
Contact: Somya Duhan    919873983874      
Principal Investigator: Jitendra Sawhney, 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, MD    918447871130      
Principal Investigator: Rahul Mehrotra, 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         
Carmel Medical Center Recruiting
Haifa, Israel, 34362
Contact: Amer Ubied    +97248250515      
Principal Investigator: Yochai Adir         
Rambam Health Corp. Completed
Haifa, Israel, 31096
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 Maffi    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         
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Young Suk Kim    82230103168      
Principal Investigator: Jong-Min Song         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Sojeong Jeon    82234101698      
Principal Investigator: Sung-A Chang         
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         
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         
Singapore
National Heart Centre Singapore Recruiting
Singapore, Singapore, 168 752
Contact: Xiu Qi Aw    6564367620      
Principal Investigator: Soo Teik Lim         
National University Hospital Recruiting
Singapore, Singapore, 119228
Contact: Geying Li    6567725456      
Principal Investigator: Wei Luen James Yip, MD         
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 Misell         
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    +8864235925253127      
Principal Investigator: Kuo-Yang Wang         
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Contact: Yu-Mei Lai    88622312345665070      
Principal Investigator: Hsao-Hsun Hsu         
United Kingdom
Papworth Hospital Recruiting
Papworth Everard, Cambridgshire, United Kingdom, CB3 8RE
Contact: Carmen Teacy    +4414808305414223      
Principal Investigator: Joanna Pepke-Zaba, M.D.         
Royal Free Hospital Recruiting
London, England, United Kingdom, NW3 2QG
Contact: Rachel Ochiel    44207317754434274      
Principal Investigator: Gerry Coghlan         
Freeman Hospital Recruiting
Newcastle upon Tyne, England, United Kingdom, NE7 7DN
Contact: Margaret Day    +01912127462      
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: NCT01560624     History of Changes
Other Study ID Numbers: TDE-PH-310
Study First Received: March 9, 2012
Last Updated: May 14, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by United Therapeutics:
PAH
PH
Clinical Worsening
Freedom
Freedom-Ev
Treprostinil
UT-15C
6 Minute walk test

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Treprostinil
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2015