Clinical trial NCT01560637: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Arterial Hypertension
Keywords: PAH
PH
FREEDOM
6 minute walk test
treprostinil
open label
Lead sponsor: United Therapeutics
Sponsor class: INDUSTRY
First posted: 2012-03-22
Enrollment: 471
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Adverse Events
timeFrame: 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 outcomes:
measure: Change in 6-Minute Walk Distance From Baseline
timeFrame: Baseline to Week 48
measure: Change in Borg Dyspnea Score From Baseline to Week 48
timeFrame: Baseline to Week 48
measure: Change From Baseline to Week 48 in WHO Functional Class
timeFrame: Baseline to Week 48
measure: Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to Week 48
timeFrame: Baseline to Week 48
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Pulmonary Specialists, Ltd.
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Fresno
country: United States
facility: University of California, San Francisco-Fresno
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Sacramento
country: United States
facility: University of California-Davis Medical Group, Advanced Lung Disease/Transplant Program
state: California
city: Torrance
country: United States
facility: David Geffen School of Medicine
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: University of Florida College of Medicine Jacksonville- Division of Pulmonary & Critical Medicine
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Austell
country: United States
facility: Piedmont - Georgia Lung Associates
state: Georgia
city: Peoria
country: United States
facility: HeartCare Midwest
state: Illinois
city: Carmel
country: United States
facility: Indiana University Hospital
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Louisville
country: United States
facility: Kentuckiana Pulmonary Associates
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Troy
country: United States
facility: Beaumont Health
state: Michigan
city: Omaha
country: United States
facility: Nebraska Medical Center
state: Nebraska
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Asheville
country: United States
facility: Asheville Cardiology Associates
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: University Hospital
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Portland
country: United States
facility: Legacy Research Institute
state: Oregon
city: Philadelphia
country: United States
facility: Perelman Center for Advanced Medicine, University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center - Presbyterian Cardiovascular Institute
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Norfolk
country: United States
facility: Sentara Cardiovascular Research Institute
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Milwaukee
country: United States
facility: Aurora Saint Luke's Medical Center
state: Wisconsin
city: Caba
country: Argentina
facility: Sanatorio San José
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Distrito Federal
city: Rosario
country: Argentina
facility: Hospital Italiano Garibaldi
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Sanatorio de la Trinidad Mitre
city: Santa Fe
country: Argentina
facility: Hospital Dr. José María Cullen
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Saint Vincents Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Macquarie University
state: New South Wales
city: Chermside
country: Australia
facility: Prince Charles Hospital
state: Queensland
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Linz
country: Austria
facility: Krankenhaus Elisabethinen Linz
state: Upper Austria
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Goiania
country: Brazil
facility: Hospital das Clinicas da Universidade Federal de Goias
state: Goias
city: Belo Horizonte
country: Brazil
facility: Hospital das Clínicas da Universidade Federal de Minas Gerais
state: Minas Gerais
city: Belo Horizonte
country: Brazil
facility: Hospital Madre Teresa
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: Complexo Hospitalar Santa Casa de Porto Alegre
state: RIO Grande DO SUL
city: Botucatu
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Botucatu- UNESP
state: SAO Paulo
city: São Paulo
country: Brazil
facility: Hospital da Clínicas da Faculdade de Medicina da Universidade de São Paulo
state: SAO Paulo
city: São Paulo
country: Brazil
facility: Escola Paulista de Medicina, Universidade Federal de São Paulo
state: SAO Paulo
city: São Paulo
country: Brazil
facility: Hospital Alemão Oswaldo Cruz
city: Calgary
country: Canada
facility: Respiratory Research Foundation
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver Coastal Health
state: British Columbia
city: London
country: Canada
facility: Lawson Health Research Institute
state: Ontario
city: Santiago
country: Chile
facility: Centro de Investigaciones TASOL
state: Region Metropolitana
city: Vitacura
country: Chile
facility: Clínica Tabancura
state: Santiago
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital
state: Hunan
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang Medical University
state: Jiangxi
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Beijing Shijitan Hospital
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
city: Shanghai
country: China
facility: Renji Hospital of Shanghai Jiaotong University
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital of Tongji University
city: Shenyang
country: China
facility: Shenyang General Hospital of Shenyang Military Command
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital, Skejby
city: Copenhagen
country: Denmark
facility: Rigshospitalet-Copenhagen University Hospital
city: Pessac
country: France
facility: Hopital Haut-Leveque, CHU Bordeaux
state: Aquitaine
city: Besancon
country: France
facility: Hopital Jean Minjoz Centre Hospitalier Universitaire Besancon
state: Franche-comte
city: Montpellier cedex 5
country: France
facility: CHU de Montpellier
state: Languedoc-roussillon
city: Vandoeuvre-Les-Nancy
country: France
facility: Hopital Brabois
state: Limousin, Lorraine
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
state: NORD Pas-de-calais
city: Marseille
country: France
facility: Centre Hospitalier Universitaire Hopital Nord
state: Provence Alpes COTE D'azur
city: Heidelberg
country: Germany
facility: Thoraxklinik am Universitätsklinikum Heidelberg
state: Baden-wuerttemberg
city: Munchen
country: Germany
facility: Ludwig-Maximilians-Universitat Munchen
state: Bayern
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
state: Bayern
city: Wurzburg
country: Germany
facility: Missionsarztliche Klinik Wurzburg gGmbH
state: Bayern
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald
state: Mecklenburg-vorpommern
city: Bochum
country: Germany
facility: Bergmannsheil Berufsgenossenschaftliche Universitätsklinik GmbH
state: Nordrhein-westfalen
city: Duisburg
country: Germany
facility: Herzzentrum Duisburg
state: Nordrhein-westfalen
city: Köln
country: Germany
facility: Universitätsklinikum Köln
state: Nordrhein-westfalen
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg Universität
state: Rheinland-pfalz
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
state: Saarland
city: Dresden
country: Germany
facility: Technische Universität Dresden
state: Sachsen
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
state: Sachsen
city: Hamburg
country: Germany
facility: Universitätskrankenhaus Hamburg-Eppendorf
city: Athens
country: Greece
facility: University General Hospital of Attikon
state: Attica
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki, "G.Papanikolaou"
state: Macedoni
city: Hyderabad
country: India
facility: CARE Hospital
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Mediciti Hospital
state: Andhra Pradesh
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
state: Delhi
city: New Delhi
country: India
facility: Indraprastha Apollo Hospital
state: Delhi
city: Ahmedabad
country: India
facility: Care Institute Medical Sciences
state: Gujarat
city: Gandhinagar
country: India
facility: Apollo Hospitals International, Ltd.
state: Gujarat
city: Gurgaon
country: India
facility: Medanta - The Medicity
state: Haryana
city: Bangalore
country: India
facility: Narayana Institute of Cardiac Sciences
state: Karnataka
city: Mumbai
country: India
facility: KEM Hospital
state: Maharashtra
city: Mumbai
country: India
facility: King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College
state: Maharashtra
city: Pune
country: India
facility: Ruby Hall Clinic
state: Maharashtra
city: Chennai
country: India
facility: Apollo Hospital
state: Tamil NADU
city: Coimbatore
country: India
facility: G. Kuppuswamy Naidu Memorial Hospital
state: Tamil NADU
city: Petach Tikvah
country: Israel
facility: Rabin Medical Center
state: Petah Tiqwa
city: Tel Hashomer
country: Israel
facility: The Chaim Sheba Medical Center at Tel Hashomer
state: Tel Aviv
city: Haifa
country: Israel
facility: Rambam Health Corp.
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria
city: Palermo
country: Italy
facility: Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico S. Matteo
city: Roma
country: Italy
facility: Azienda Policlinico Umberto I di Roma
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Tlalpan
country: Mexico
facility: Instituto Nacional de Cardiologia Ignacio Chavez
state: Distrito Federal
city: Monterrey
country: Mexico
facility: Unidad de Investigacion Clinica en Medicina S.C.
state: Nuevo LEON
city: Nijmegen
country: Netherlands
facility: Universitair Medisch Centrum Sint Radboud
state: Gelderland
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum
state: Noord-holland
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
city: Krakow
country: Poland
facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K. Marcinkowskiego w Poznaniu
city: Malogoskie
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II
city: Otwock
country: Poland
facility: Europejskie Centrum Zdrowia Otwock, Szpital im. Fryderyka Chopina
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
state: Vastra Gotaland
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Solna
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
state: Tainan CITY
city: Kaohsiung
country: Taiwan
facility: Veterans General Hospital-Kaohsiung
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Papworth Everard
country: United Kingdom
facility: Papworth Hospital
state: Cambridgshire
city: London
country: United Kingdom
facility: Royal Free Hospital
state: England
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
state: England
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
state: England
Study officials:
References: