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

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ClinicalTrials.gov Identifier: NCT01560624
Recruitment Status : Active, not recruiting
First Posted : March 22, 2012
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
United Therapeutics

Brief Summary:
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 or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: UT-15C (treprostinil diethanolamine) Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 850 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2012
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Time to first clinical worsening event [ Time Frame: From randomization to approximately 4 years ]

Secondary Outcome Measures :
  1. Change in 6 minute walk distance [ Time Frame: From Baseline to Week 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 Screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01560624


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Locations
United States, Arizona
Arizona Pulmonary Specialists, Ltd.
Phoenix, Arizona, United States, 85012
University of Arizona
Tucson, Arizona, United States, 85724
United States, California
University of California, San Francisco-Fresno
Fresno, California, United States, 93721
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90211
University of California-Davis Medical Group, Advanced Lung Disease/Transplant Program
Sacramento, California, United States, 95817
David Geffen School of Medicine
Torrance, California, United States, 90502
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
University of Florida College of Medicine Jacksonville- Division of Pulmonary & Critical Medicine
Jacksonville, Florida, United States, 32209
University of Florida College of Medicine Jacksonville
Jacksonville, Florida, United States, 32209
University of Florida College of Medicine, Jacksonville
Jacksonville, Florida, United States, 32209
Cleveland Clinic Florida
Weston, Florida, United States, 33331
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Augusta University
Augusta, Georgia, United States, 30912
Piedmont - Georgia Lung Associates
Austell, Georgia, United States, 30106
United States, Illinois
HeartCare Midwest
Peoria, Illinois, United States, 61614
United States, Indiana
Indiana University Hospital
Carmel, Indiana, United States, 46032
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 55242
United States, Kentucky
Kentuckiana Pulmonary Associates
Louisville, Kentucky, United States, 40202
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
Beaumont Health
Troy, Michigan, United States, 48085
United States, Nebraska
Nebraska Medical Center
Omaha, Nebraska, United States, 68198-5990
United States, New Jersey
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Asheville Cardiology Associates
Asheville, North Carolina, United States, 28803
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0564
University Hospital
Cleveland, Ohio, United States, 44106
The Ohio State University
Columbus, Ohio, United States, 43321
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97201-3098
Legacy Research Institute
Portland, Oregon, United States, 97210
United States, Pennsylvania
Perelman Center for Advanced Medicine; University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center - Presbyterian Cardiovascular Institute
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
United States, Virginia
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States, 23507
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Wisconsin
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Argentina
Sanatorio San José
Caba, Buenos Aires, Argentina, C1425DUH
Hospital Italiano de Buenos Aires
Ciudad Autónoma de Buenos Aires, Distrito Federal, Argentina, C1181ACH
Hospital Italiano Garibaldi
Rosario, Santa Fe, Argentina, S2001OAD
Sanatorio de la Trinidad Mitre
Buenos Aires, Argentina
Hospital Dr. José María Cullen
Santa Fe, Argentina, S3000EOY
Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Nepean Hospital
Kingswood, New South Wales, Australia, 2751
Saint Vincents Hospital
Sydney, New South Wales, Australia, 2010
Macquarie University
Sydney, New South Wales, Australia, 2109
Australia, Queensland
Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Australia, Tasmania
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7000
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3052
Austria
Krankenhaus Elisabethinen Linz
Linz, Upper Austria, Austria, 4020
Medizinische Universität Wien
Wien, Austria, 1090
Brazil
Hospital das Clinicas da Universidade Federal de Goias
Goiania, Goias, Brazil, 74605-050
Hospital das Clínicas da Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 30130-100
Hospital Madre Teresa
Belo Horizonte, Minas Gerais, Brazil, 30380-090
Complexo Hospitalar Santa Casa de Porto Alegre
Porto Alegre, RIO Grande DO SUL, Brazil, 90020-090
Hospital das Clínicas da Faculdade de Medicina de Botucatu- UNESP
Botucatu, SAO Paulo, Brazil, 18618-970
Hospital da Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, SAO Paulo, Brazil, 05403-000
Escola Paulista de Medicina, Universidade Federal de São Paulo
São Paulo, SAO Paulo, Brazil
Hospital Alemão Oswaldo Cruz
São Paulo, Brazil, 01323-020
Canada, Alberta
Respiratory Research Foundation
Calgary, Alberta, Canada, T1Y 6J4
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Vancouver Coastal Health
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
Lawson Health Research Institute
London, Ontario, Canada, N6A 5A5
Chile
Centro de Investigaciones TASOL
Santiago, Region Metropolitana, Chile, 7500710
Clínica Tabancura
Vitacura, Santiago, Chile, 7650018
China, Beijing
Beijing Chao-Yang Hospital
Beijing, Beijing, China, 100020
China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
China, Hubei
Wuhan Asia Heart Hospital
Wuhan, Hubei, China, 430022
China, Hunan
Xiangya Hospital
Changsha, Hunan, China, 410008
China, Jiangsu
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029
China, Jiangxi
The Second Affiliated Hospital of Nanchang Medical University
Nanchang, Jiangxi, China, 330006
China, Shanghai
Zhongshan Hospital Fudan University
Shanghai, Shanghai, China, 200032
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, China, 200120
China, Sichuan
West China Hospital
Chengdu, Sichuan, China, 610047
China
Peking Union Medical College Hospital
Beijing, China, 100005
Beijing Shijitan Hospital
Beijing, China, 100038
Chinese PLA General Hospital
Beijing, China, 100853
The Affiliated Hospital of Qingdao University
Qingdao, China, 26603
Renji Hospital of Shanghai Jiaotong University
Shanghai, China, 200001
Shanghai Pulmonary Hospital of Tongji University
Shanghai, China, 200433
Shenyang General Hospital of Shenyang Military Command
Shenyang, China, 110015
Denmark
Aarhus Universitetshospital, Skejby
Aarhus, Denmark, 8200
Rigshospitalet-Copenhagen University Hospital
Copenhagen, Denmark, 2100
France
Hopital Haut-Leveque, CHU Bordeaux
Pessac, Aquitaine, France, 33064
Hopital Jean Minjoz Centre Hospitalier Universitaire Besancon
Besancon, Franche-comte, France, 25030
CHU de Montpellier
Montpellier Cedex 5, Languedoc-roussillon, France, 34295
Hopital Brabois
Vandoeuvre-Les-Nancy, Limousin, Lorraine, France, 54500
Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
Lille, NORD Pas-de-calais, France, 59037
Centre Hospitalier Universitaire Hopital Nord
Marseille, Provence Alpes COTE D'azur, France, 13015
Germany
Thoraxklinik am Universitätsklinikum Heidelberg
Heidelberg, Baden-wuerttemberg, Germany, 69126
Ludwig-Maximilians-Universitat Munchen
Munchen, Bayern, Germany, 81377
Universitätsklinikum Regensburg
Regensburg, Bayern, Germany, 93053
Missionsarztliche Klinik Wurzburg gGmbH
Wurzburg, Bayern, Germany, 97074
Universitätsmedizin Greifswald
Greifswald, Mecklenburg-vorpommern, Germany, 17475
Bergmannsheil Berufsgenossenschaftliche Universitätsklinik GmbH
Bochum, Nordrhein-westfalen, Germany, 44789
Herzzentrum Duisburg
Duisburg, Nordrhein-westfalen, Germany, 47137
Universitätsklinikum Köln
Köln, Nordrhein-westfalen, Germany, 50937
Universitätsmedizin der Johannes Gutenberg Universität
Mainz, Rheinland-pfalz, Germany, 55131
Universitätsklinikum des Saarlandes
Homburg, Saarland, Germany, 66424
Technische Universität Dresden
Dresden, Sachsen, Germany, 01307
Universitätsklinikum Leipzig
Leipzig, Sachsen, Germany, 04103
Universitätskrankenhaus Hamburg-Eppendorf
Hamburg, Germany, 20246
Technische Universität Dresden
Sachsen, Germany, 01307
Greece
University General Hospital of Attikon
Athens, Attica, Greece, 12462
General Hospital of Thessaloniki, "G.Papanikolaou"
Thessaloniki, Macedoni, Greece, 57010
India
CARE Hospital
Hyderabad, Andhra Pradesh, India, 500 001
Mediciti Hospital
Hyderabad, Andhra Pradesh, India, 500 063
Sir Ganga Ram Hospital
New Delhi, Delhi, India, 110060
Indraprastha Apollo Hospital
New Delhi, Delhi, India, 110076
Care Institute Medical Sciences
Ahmedabad, Gujarat, India, 38006
Apollo Hospitals International, Ltd.
Gandhinagar, Gujarat, India, 382428
Medanta - The Medicity
Gurgaon, Haryana, India, 122 001
Narayana Institute of Cardiac Sciences
Bangalore, Karnataka, India, 560 099
KEM Hospital
Mumbai, Maharashtra, India, 400012
Ruby Hall Clinic
Pune, Maharashtra, India, 411 001
Apollo Hospital
Chennai, Tamil NADU, India, 600006
G. Kuppuswamy Naidu Memorial Hospital
Coimbatore, Tamil NADU, India, 641037
Israel
Rabin Medical Center
Petach Tikvah, Petah Tiqwa, Israel, 49100
The Chaim Sheba Medical Center at Tel Hashomer
Tel Hashomer, Tel Aviv, Israel, 52621
Rambam Health Corp.
Haifa, Israel, 31096
Carmel Medical Center
Haifa, Israel, 34362
Hadassah Medical Center
Jerusalem, Israel, 91120
Italy
Azienda Ospedaliera Universitaria
Napoli, Italy
Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)
Palermo, Italy, 90127
Fondazione IRCCS Policlinico S. Matteo
Pavia, Italy, 27100
Azienda Policlinico Umberto I di Roma
Roma, Italy, 00161
Korea, Republic of
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 405-760
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 120-752
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Mexico
Instituto Nacional de Cardiologia Ignacio Chavez
Tlalpan, Distrito Federal, Mexico, 14080
Unidad de Investigacion Clinica en Medicina S.C.
Monterrey, Nuevo LEON, Mexico, 64718
Netherlands
Universitair Medisch Centrum Sint Radboud
Nijmegen, Gelderland, Netherlands, 6525 GA
Vrije Universiteit Medisch Centrum
Amsterdam, Noord-holland, Netherlands, 1081 HV
Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Poland, 15276
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K. Marcinkowskiego w Poznaniu
Krakow, Poland, 61848
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Malogoskie, Poland, 31202
Europejskie Centrum Zdrowia Otwock, Szpital im. Fryderyka Chopina
Otwock, Poland
Singapore
National University Hospital
Singapore, Singapore, 119228
National Heart Centre Singapore
Singapore, Singapore, 168 752
Sweden
Sahlgrenska University Hospital
Göteborg, Vastra Gotaland, Sweden, 413 45
Karolinska University Hospital Solna
Stockholm, Sweden, 171 76
Taiwan
National Cheng Kung University Hospital
Tainan, Tainan CITY, Taiwan, 70403
Veterans General Hospital-Kaohsiung
Kaohsiung, Taiwan, 81362
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
National Taiwan University Hospital
Taipei, Taiwan, 10002
United Kingdom
Papworth Hospital
Papworth Everard, Cambridgshire, United Kingdom, CB3 8RE
Royal Free Hospital
London, England, United Kingdom, NW3 2QG
Freeman Hospital
Newcastle upon Tyne, England, United Kingdom, NE7 7DN
Royal Hallamshire Hospital
Sheffield, England, United Kingdom, S10 2JF
Sponsors and Collaborators
United Therapeutics

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01560624     History of Changes
Other Study ID Numbers: TDE-PH-310
First Posted: March 22, 2012    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018

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

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