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

Trial of the Early Combination of Oral Treprostinil With a PDE-5 Inhibitor or ERA in Subjects With Pulmonary Arterial Hypertension (FREEDOM-Ev)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by United Therapeutics
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01560624
First received: March 9, 2012
Last updated: June 24, 2014
Last verified: June 2014
  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 PDE-5 inhibitor or ERA for at least 30 days but not more than one year prior to 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, Event Driven Study to Compare the Time to First Clinical Worsening in Subjects With Pulmonary Arterial Hypertension Receiving UT-15C in Combination With a PDE5-I or ERA Compared With a PDE5-I or ERA Alone

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: 858
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 a PDE-5 inhibitor or ERA 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
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 Recruiting
Peoria, Illinois, United States, 61614
Contact: Rita Klundt    309-691-4410      
Principal Investigator: Ron Oren, MD         
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: Sif Hansdottir, 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 Recruiting
Baltimore, Maryland, United States, 21201
Contact: Myung Park, M.D.    410-328-7260      
Principal Investigator: Myung Park, M.D.         
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 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, 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
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, 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         
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    +00610731395159      
Principal Investigator: Fiona Kermeen         
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 Recruiting
Parkville, Victoria, Australia, 3052
Contact: Sue Schulz    393428490      
Principal Investigator: David Smallwood         
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         
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.         
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
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         
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       cjsmile321@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: Chaouat Ari         
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         
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.         
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
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
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    +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: June 24, 2014
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, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Treprostinil
Phosphodiesterase 5 Inhibitors
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014