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

Primary Purpose

Pulmonary Arterial Hypertension

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
UT-15C (treprostinil diolamine)
Sponsored by
United Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring PAH, PH, FREEDOM, 6 minute walk test, treprostinil, open label

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participated in United Therapeutics Study TDE-PH-310
  • All women of childbearing potential (WOCBP) must have practiced true abstinence from intercourse when it was in line with their preferred and usual lifestyle or used 2 different forms of highly effective contraception for the duration of the study and for at least 30 days after discontinuing study medication.
  • Males who participated in the study must have used a condom during the length of the study and for at least 48 hours after their last dose of study medication.

Exclusion Criteria:

  • The subject was pregnant or lactating.
  • The subject had received infused or inhaled prostacyclin therapy for 29 days or more.
  • The subject was prematurely discontinued from TDE-PH-310 for reasons other than a clinical worsening event.
  • The subject developed a concurrent illness or condition during the conduct of TDE-PH-310 which, in the opinion of the Investigator, would represent a risk to their overall health if they enrolled in this study.

Sites / Locations

  • Arizona Pulmonary Specialists, Ltd.
  • University of Arizona
  • University of California, San Francisco-Fresno
  • Cedars-Sinai Medical Center
  • University of California-Davis Medical Group, Advanced Lung Disease/Transplant Program
  • David Geffen School of Medicine
  • University of Colorado Hospital
  • University of Florida
  • University of Florida College of Medicine Jacksonville- Division of Pulmonary & Critical Medicine
  • Cleveland Clinic Florida
  • Emory University Hospital
  • Augusta University
  • Piedmont - Georgia Lung Associates
  • HeartCare Midwest
  • Indiana University Hospital
  • University of Iowa Hospitals and Clinics
  • Kentuckiana Pulmonary Associates
  • University of Maryland
  • Tufts Medical Center
  • Massachusetts General Hospital
  • Henry Ford Health System
  • Beaumont Health
  • Nebraska Medical Center
  • Newark Beth Israel Medical Center
  • University of Rochester
  • Asheville Cardiology Associates
  • University of Cincinnati
  • University Hospital
  • Ohio State University
  • Oregon Health and Science University
  • Legacy Research Institute
  • Perelman Center for Advanced Medicine, University of Pennsylvania
  • University of Pittsburgh Medical Center - Presbyterian Cardiovascular Institute
  • Rhode Island Hospital
  • The University of Texas Health Science Center at Houston
  • Sentara Cardiovascular Research Institute
  • Virginia Commonwealth University
  • Aurora Saint Luke's Medical Center
  • Sanatorio San José
  • Hospital Italiano de Buenos Aires
  • Hospital Italiano Garibaldi
  • Sanatorio de la Trinidad Mitre
  • Hospital Dr. José María Cullen
  • Royal Prince Alfred Hospital
  • Nepean Hospital
  • Saint Vincents Hospital
  • Macquarie University
  • Prince Charles Hospital
  • Royal Hobart Hospital
  • The Alfred Hospital
  • Royal Melbourne Hospital
  • Krankenhaus Elisabethinen Linz
  • Medizinische Universität Wien
  • Hospital das Clinicas da Universidade Federal de Goias
  • Hospital das Clínicas da Universidade Federal de Minas Gerais
  • Hospital Madre Teresa
  • Complexo Hospitalar Santa Casa de Porto Alegre
  • Hospital das Clínicas da Faculdade de Medicina de Botucatu- UNESP
  • Hospital da Clínicas da Faculdade de Medicina da Universidade de São Paulo
  • Escola Paulista de Medicina, Universidade Federal de São Paulo
  • Hospital Alemão Oswaldo Cruz
  • Respiratory Research Foundation
  • University of Alberta Hospital
  • Vancouver Coastal Health
  • Lawson Health Research Institute
  • Centro de Investigaciones TASOL
  • Clínica Tabancura
  • Beijing Chao-Yang Hospital
  • Guangdong General Hospital
  • Wuhan Asia Heart Hospital
  • Xiangya Hospital
  • The First Affiliated Hospital of Nanjing Medical University
  • The Second Affiliated Hospital of Nanchang Medical University
  • Zhongshan Hospital Fudan University
  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • West China Hospital
  • Peking Union Medical College Hospital
  • Beijing Shijitan Hospital
  • Chinese PLA General Hospital
  • The Affiliated Hospital of Qingdao University
  • Renji Hospital of Shanghai Jiaotong University
  • Shanghai Pulmonary Hospital of Tongji University
  • Shenyang General Hospital of Shenyang Military Command
  • Aarhus Universitetshospital, Skejby
  • Rigshospitalet-Copenhagen University Hospital
  • Hopital Haut-Leveque, CHU Bordeaux
  • Hopital Jean Minjoz Centre Hospitalier Universitaire Besancon
  • CHU de Montpellier
  • Hopital Brabois
  • Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
  • Centre Hospitalier Universitaire Hopital Nord
  • Thoraxklinik am Universitätsklinikum Heidelberg
  • Ludwig-Maximilians-Universitat Munchen
  • Universitätsklinikum Regensburg
  • Missionsarztliche Klinik Wurzburg gGmbH
  • Universitätsmedizin Greifswald
  • Bergmannsheil Berufsgenossenschaftliche Universitätsklinik GmbH
  • Herzzentrum Duisburg
  • Universitätsklinikum Köln
  • Universitätsmedizin der Johannes Gutenberg Universität
  • Universitätsklinikum des Saarlandes
  • Technische Universität Dresden
  • Universitätsklinikum Leipzig
  • Universitätskrankenhaus Hamburg-Eppendorf
  • University General Hospital of Attikon
  • General Hospital of Thessaloniki, "G.Papanikolaou"
  • CARE Hospital
  • Mediciti Hospital
  • Sir Ganga Ram Hospital
  • Indraprastha Apollo Hospital
  • Care Institute Medical Sciences
  • Apollo Hospitals International, Ltd.
  • Medanta - The Medicity
  • Narayana Institute of Cardiac Sciences
  • KEM Hospital
  • King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College
  • Ruby Hall Clinic
  • Apollo Hospital
  • G. Kuppuswamy Naidu Memorial Hospital
  • Rabin Medical Center
  • The Chaim Sheba Medical Center at Tel Hashomer
  • Rambam Health Corp.
  • Carmel Medical Center
  • Hadassah Medical Center
  • Azienda Ospedaliera Universitaria
  • Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)
  • Fondazione IRCCS Policlinico S. Matteo
  • Azienda Policlinico Umberto I di Roma
  • Gachon University Gil Medical Center
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Samsung Medical Center
  • Asan Medical Center
  • Instituto Nacional de Cardiologia Ignacio Chavez
  • Unidad de Investigacion Clinica en Medicina S.C.
  • Universitair Medisch Centrum Sint Radboud
  • Vrije Universiteit Medisch Centrum
  • Uniwersytecki Szpital Kliniczny w Bialymstoku
  • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K. Marcinkowskiego w Poznaniu
  • Krakowski Szpital Specjalistyczny im. Jana Pawla II
  • Europejskie Centrum Zdrowia Otwock, Szpital im. Fryderyka Chopina
  • National University Hospital
  • National Heart Centre Singapore
  • Sahlgrenska University Hospital
  • Karolinska University Hospital Solna
  • National Cheng Kung University Hospital
  • Veterans General Hospital-Kaohsiung
  • Taichung Veterans General Hospital
  • National Taiwan University Hospital
  • Papworth Hospital
  • Royal Free Hospital
  • Freeman Hospital
  • Royal Hallamshire Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

UT-15C

Arm Description

Open label access

Outcomes

Primary Outcome Measures

Number of Adverse Events
All subjects who received oral treprostinil in TDE-PH-311 were included in the Safety population. All AEs were captured from the time the ICF was signed. All AEs were followed until resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for up to 30 days if the AE extended beyond the final visit. All SAEs were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final visit. The overall summary of AEs includes the number of subjects with any AE, the number of subjects with any study drug-related AEs, the number of subjects with AEs leading to study drug withdrawal, the number of subjects with any serious AEs, the number of subjects with any severe AEs, and the number of subjects with any study drug-related severe/serious AEs. AEs were coded using the Medical Dictionary for Regulatory Activities.

Secondary Outcome Measures

Change in 6-Minute Walk Distance From Baseline
A summary of change from Baseline in 6MWD at Week 48 for the Safety Population is provided. The Safety Population is all subjects who received oral treprostinil in TDE-PH-311.
Change in Borg Dyspnea Score From Baseline to Week 48
Change in Borg Dyspnea Score from at Week 48 is provided for the Safety Population (all subjects who received oral treprostinil in TDE-PH-311). The Borg Dyspnea Scale is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise and was administered during six-minute walk testing (6MWT), one of the most common and frequently used measures to assess disease severity in PAH. The numbers on the scale are as follows: 0 (no shortness of breath [SOB]), 0.5 (very very slight SOB), 1 (very slight SOB), 3 (moderate SOB), 4 (somewhat severe SOB), 5 (severe SOB), 7 (very severe SOB), 9 (very very severe SOB), 10 (maximal SOB).
Change From Baseline to Week 48 in WHO Functional Class
Change from Baseline at Week 48 in WHO FC in the Safety Population (all subjects who received oral treprostinil in TDE-PH-311). The World Health Organization functional classification (WHO-FC) is a clinician-rated assessment used widely to assess PAH severity and functioning. Class I (least severe): Patients are without limitation of physical activity. Class II: Patients are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope. Class III: Marked limitation of physical activity. They are comfortable at rest. Class IV (most severe): Inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure.
Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to Week 48
Change in N-terminal pro-brain natriuretic peptide from Baseline at Week 48 for the Safety Population (any subject who received oral treprostinil in TDE-PH-311)

Full Information

First Posted
March 9, 2012
Last Updated
May 6, 2022
Sponsor
United Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01560637
Brief Title
An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 11, 2013 (Actual)
Primary Completion Date
August 12, 2021 (Actual)
Study Completion Date
August 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United Therapeutics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
PAH, PH, FREEDOM, 6 minute walk test, treprostinil, open label

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
471 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UT-15C
Arm Type
Experimental
Arm Description
Open label access
Intervention Type
Drug
Intervention Name(s)
UT-15C (treprostinil diolamine)
Intervention Description
UT-15C extended release oral tablet three times daily
Primary Outcome Measure Information:
Title
Number of Adverse Events
Description
All subjects who received oral treprostinil in TDE-PH-311 were included in the Safety population. All AEs were captured from the time the ICF was signed. All AEs were followed until resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for up to 30 days if the AE extended beyond the final visit. All SAEs were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final visit. The overall summary of AEs includes the number of subjects with any AE, the number of subjects with any study drug-related AEs, the number of subjects with AEs leading to study drug withdrawal, the number of subjects with any serious AEs, the number of subjects with any severe AEs, and the number of subjects with any study drug-related severe/serious AEs. AEs were coded using the Medical Dictionary for Regulatory Activities.
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
Secondary Outcome Measure Information:
Title
Change in 6-Minute Walk Distance From Baseline
Description
A summary of change from Baseline in 6MWD at Week 48 for the Safety Population is provided. The Safety Population is all subjects who received oral treprostinil in TDE-PH-311.
Time Frame
Baseline to Week 48
Title
Change in Borg Dyspnea Score From Baseline to Week 48
Description
Change in Borg Dyspnea Score from at Week 48 is provided for the Safety Population (all subjects who received oral treprostinil in TDE-PH-311). The Borg Dyspnea Scale is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise and was administered during six-minute walk testing (6MWT), one of the most common and frequently used measures to assess disease severity in PAH. The numbers on the scale are as follows: 0 (no shortness of breath [SOB]), 0.5 (very very slight SOB), 1 (very slight SOB), 3 (moderate SOB), 4 (somewhat severe SOB), 5 (severe SOB), 7 (very severe SOB), 9 (very very severe SOB), 10 (maximal SOB).
Time Frame
Baseline to Week 48
Title
Change From Baseline to Week 48 in WHO Functional Class
Description
Change from Baseline at Week 48 in WHO FC in the Safety Population (all subjects who received oral treprostinil in TDE-PH-311). The World Health Organization functional classification (WHO-FC) is a clinician-rated assessment used widely to assess PAH severity and functioning. Class I (least severe): Patients are without limitation of physical activity. Class II: Patients are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope. Class III: Marked limitation of physical activity. They are comfortable at rest. Class IV (most severe): Inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure.
Time Frame
Baseline to Week 48
Title
Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to Week 48
Description
Change in N-terminal pro-brain natriuretic peptide from Baseline at Week 48 for the Safety Population (any subject who received oral treprostinil in TDE-PH-311)
Time Frame
Baseline to Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participated in United Therapeutics Study TDE-PH-310 All women of childbearing potential (WOCBP) must have practiced true abstinence from intercourse when it was in line with their preferred and usual lifestyle or used 2 different forms of highly effective contraception for the duration of the study and for at least 30 days after discontinuing study medication. Males who participated in the study must have used a condom during the length of the study and for at least 48 hours after their last dose of study medication. Exclusion Criteria: The subject was pregnant or lactating. The subject had received infused or inhaled prostacyclin therapy for 29 days or more. The subject was prematurely discontinued from TDE-PH-310 for reasons other than a clinical worsening event. The subject developed a concurrent illness or condition during the conduct of TDE-PH-310 which, in the opinion of the Investigator, would represent a risk to their overall health if they enrolled in this study.
Facility Information:
Facility Name
Arizona Pulmonary Specialists, Ltd.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of California, San Francisco-Fresno
City
Fresno
State/Province
California
ZIP/Postal Code
93701
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
University of California-Davis Medical Group, Advanced Lung Disease/Transplant Program
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
David Geffen School of Medicine
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of Florida College of Medicine Jacksonville- Division of Pulmonary & Critical Medicine
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Piedmont - Georgia Lung Associates
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Facility Name
HeartCare Midwest
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Indiana University Hospital
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
55242
Country
United States
Facility Name
Kentuckiana Pulmonary Associates
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Beaumont Health
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-5990
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Asheville Cardiology Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
University Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43321
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201-3098
Country
United States
Facility Name
Legacy Research Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Perelman Center for Advanced Medicine, University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Medical Center - Presbyterian Cardiovascular Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Sentara Cardiovascular Research Institute
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Aurora Saint Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Sanatorio San José
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1425DUH
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
Ciudad Autónoma de Buenos Aires
State/Province
Distrito Federal
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Hospital Italiano Garibaldi
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2001OAD
Country
Argentina
Facility Name
Sanatorio de la Trinidad Mitre
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Dr. José María Cullen
City
Santa Fe
ZIP/Postal Code
S3000EOY
Country
Argentina
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Nepean Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2751
Country
Australia
Facility Name
Saint Vincents Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Macquarie University
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Krankenhaus Elisabethinen Linz
City
Linz
State/Province
Upper Austria
ZIP/Postal Code
4020
Country
Austria
Facility Name
Medizinische Universität Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Hospital das Clinicas da Universidade Federal de Goias
City
Goiania
State/Province
Goias
ZIP/Postal Code
74605-050
Country
Brazil
Facility Name
Hospital das Clínicas da Universidade Federal de Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-100
Country
Brazil
Facility Name
Hospital Madre Teresa
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30380-090
Country
Brazil
Facility Name
Complexo Hospitalar Santa Casa de Porto Alegre
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
Hospital das Clínicas da Faculdade de Medicina de Botucatu- UNESP
City
Botucatu
State/Province
SAO Paulo
ZIP/Postal Code
18618-970
Country
Brazil
Facility Name
Hospital da Clínicas da Faculdade de Medicina da Universidade de São Paulo
City
São Paulo
State/Province
SAO Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Escola Paulista de Medicina, Universidade Federal de São Paulo
City
São Paulo
State/Province
SAO Paulo
Country
Brazil
Facility Name
Hospital Alemão Oswaldo Cruz
City
São Paulo
ZIP/Postal Code
01323-020
Country
Brazil
Facility Name
Respiratory Research Foundation
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 6J4
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Vancouver Coastal Health
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Lawson Health Research Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Centro de Investigaciones TASOL
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
7500710
Country
Chile
Facility Name
Clínica Tabancura
City
Vitacura
State/Province
Santiago
ZIP/Postal Code
7650018
Country
Chile
Facility Name
Beijing Chao-Yang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Wuhan Asia Heart Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Xiangya Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
The Second Affiliated Hospital of Nanchang Medical University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610047
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100005
Country
China
Facility Name
Beijing Shijitan Hospital
City
Beijing
ZIP/Postal Code
100038
Country
China
Facility Name
Chinese PLA General Hospital
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
ZIP/Postal Code
26603
Country
China
Facility Name
Renji Hospital of Shanghai Jiaotong University
City
Shanghai
ZIP/Postal Code
200001
Country
China
Facility Name
Shanghai Pulmonary Hospital of Tongji University
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Shenyang General Hospital of Shenyang Military Command
City
Shenyang
ZIP/Postal Code
110015
Country
China
Facility Name
Aarhus Universitetshospital, Skejby
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Rigshospitalet-Copenhagen University Hospital
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Hopital Haut-Leveque, CHU Bordeaux
City
Pessac
State/Province
Aquitaine
ZIP/Postal Code
33064
Country
France
Facility Name
Hopital Jean Minjoz Centre Hospitalier Universitaire Besancon
City
Besancon
State/Province
Franche-comte
ZIP/Postal Code
25030
Country
France
Facility Name
CHU de Montpellier
City
Montpellier cedex 5
State/Province
Languedoc-roussillon
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital Brabois
City
Vandoeuvre-Les-Nancy
State/Province
Limousin, Lorraine
ZIP/Postal Code
54500
Country
France
Facility Name
Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
City
Lille
State/Province
NORD Pas-de-calais
ZIP/Postal Code
59037
Country
France
Facility Name
Centre Hospitalier Universitaire Hopital Nord
City
Marseille
State/Province
Provence Alpes COTE D'azur
ZIP/Postal Code
13015
Country
France
Facility Name
Thoraxklinik am Universitätsklinikum Heidelberg
City
Heidelberg
State/Province
Baden-wuerttemberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Ludwig-Maximilians-Universitat Munchen
City
Munchen
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
Facility Name
Universitätsklinikum Regensburg
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
Facility Name
Missionsarztliche Klinik Wurzburg gGmbH
City
Wurzburg
State/Province
Bayern
ZIP/Postal Code
97074
Country
Germany
Facility Name
Universitätsmedizin Greifswald
City
Greifswald
State/Province
Mecklenburg-vorpommern
ZIP/Postal Code
17475
Country
Germany
Facility Name
Bergmannsheil Berufsgenossenschaftliche Universitätsklinik GmbH
City
Bochum
State/Province
Nordrhein-westfalen
ZIP/Postal Code
44789
Country
Germany
Facility Name
Herzzentrum Duisburg
City
Duisburg
State/Province
Nordrhein-westfalen
ZIP/Postal Code
47137
Country
Germany
Facility Name
Universitätsklinikum Köln
City
Köln
State/Province
Nordrhein-westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg Universität
City
Mainz
State/Province
Rheinland-pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66424
Country
Germany
Facility Name
Technische Universität Dresden
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitätskrankenhaus Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
University General Hospital of Attikon
City
Athens
State/Province
Attica
ZIP/Postal Code
12462
Country
Greece
Facility Name
General Hospital of Thessaloniki, "G.Papanikolaou"
City
Thessaloniki
State/Province
Macedoni
ZIP/Postal Code
57010
Country
Greece
Facility Name
CARE Hospital
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 001
Country
India
Facility Name
Mediciti Hospital
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 063
Country
India
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Indraprastha Apollo Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110076
Country
India
Facility Name
Care Institute Medical Sciences
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
38006
Country
India
Facility Name
Apollo Hospitals International, Ltd.
City
Gandhinagar
State/Province
Gujarat
ZIP/Postal Code
382428
Country
India
Facility Name
Medanta - The Medicity
City
Gurgaon
State/Province
Haryana
ZIP/Postal Code
122 001
Country
India
Facility Name
Narayana Institute of Cardiac Sciences
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 099
Country
India
Facility Name
KEM Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Name
King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Name
Ruby Hall Clinic
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 001
Country
India
Facility Name
Apollo Hospital
City
Chennai
State/Province
Tamil NADU
ZIP/Postal Code
600006
Country
India
Facility Name
G. Kuppuswamy Naidu Memorial Hospital
City
Coimbatore
State/Province
Tamil NADU
ZIP/Postal Code
641037
Country
India
Facility Name
Rabin Medical Center
City
Petach Tikvah
State/Province
Petah Tiqwa
ZIP/Postal Code
49100
Country
Israel
Facility Name
The Chaim Sheba Medical Center at Tel Hashomer
City
Tel Hashomer
State/Province
Tel Aviv
ZIP/Postal Code
52621
Country
Israel
Facility Name
Rambam Health Corp.
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Azienda Ospedaliera Universitaria
City
Napoli
Country
Italy
Facility Name
Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Fondazione IRCCS Policlinico S. Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Policlinico Umberto I di Roma
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Instituto Nacional de Cardiologia Ignacio Chavez
City
Tlalpan
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Unidad de Investigacion Clinica en Medicina S.C.
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64718
Country
Mexico
Facility Name
Universitair Medisch Centrum Sint Radboud
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Vrije Universiteit Medisch Centrum
City
Amsterdam
State/Province
Noord-holland
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Uniwersytecki Szpital Kliniczny w Bialymstoku
City
Bialystok
ZIP/Postal Code
15276
Country
Poland
Facility Name
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K. Marcinkowskiego w Poznaniu
City
Krakow
ZIP/Postal Code
61848
Country
Poland
Facility Name
Krakowski Szpital Specjalistyczny im. Jana Pawla II
City
Malogoskie
ZIP/Postal Code
31202
Country
Poland
Facility Name
Europejskie Centrum Zdrowia Otwock, Szpital im. Fryderyka Chopina
City
Otwock
Country
Poland
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
National Heart Centre Singapore
City
Singapore
ZIP/Postal Code
168 752
Country
Singapore
Facility Name
Sahlgrenska University Hospital
City
Göteborg
State/Province
Vastra Gotaland
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Karolinska University Hospital Solna
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
National Cheng Kung University Hospital
City
Tainan
State/Province
Tainan CITY
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
Veterans General Hospital-Kaohsiung
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Papworth Hospital
City
Papworth Everard
State/Province
Cambridgshire
ZIP/Postal Code
CB3 8RE
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
State/Province
England
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle upon Tyne
State/Province
England
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S10 2JF
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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