An Open-Label Extension Trial of UT-15C Sustained-release (SR) in Subjects With Pulmonary Arterial Hypertension
NCT ID: NCT01027949
Last Updated: 2021-05-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
894 participants
INTERVENTIONAL
2007-01-16
2020-02-12
Brief Summary
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Detailed Description
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Adverse events (AEs) were reported continuously throughout the study; any AEs ongoing at the time of discharge from Studies TDE PH-301, TDE PH-302, TDE-PH-308, TDE-PH-202, TDE-PH-203, and TDE-PH-205 were recorded as AEs and marked as "ongoing from previous study" in the subject's electronic Case Report Form (eCRF). Study drug dosing and pulmonary arterial hypertension (PAH) concomitant medication usage were assessed at each scheduled study visit and recorded in the subject's eCRF.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Oral Treprostinil
Subjects from previous studies TDE-PH-202 (NCT01104870), TDE-PH-203 (NCT01477333), and TDE-PH-205 (NCT01588405), TDE-PH-301 (NCT00325442), TDE-PH-302 (NCT00325403), or TDE PH-308 (NCT00887978). Subjects were instructed to take the appropriate amount of 0.125, 0.25, 0.5, 1, and/or 2.5 mg tablets based upon their prescribed dose. Investigators were instructed to increase the dose of oral treprostinil in the absence of dose limiting drug-related AEs to ensure each subject received the optimal clinical dose throughout the study
Oral Treprostinil
Oral sustained release tablet, twice or thrice daily. Open label study with active drug, no other intervention arms.
Interventions
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Oral Treprostinil
Oral sustained release tablet, twice or thrice daily. Open label study with active drug, no other intervention arms.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The subject voluntarily gave informed consent to participate in the study.
3. Women of childbearing potential includes any female who had experienced menarche and who had not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or was not postmenopausal (defined as amenorrhea for at least 12 consecutive months). Sexually active women of childbearing potential must have used 2 effective forms of contraception during the length of the study. Medically acceptable forms of effective contraception included: (1) approved hormonal contraceptives (such as birth control pills), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, (3) an intrauterine device, (4) partner vasectomy, or (5) abstinence. Males participating in the study must have used a condom during the length of the study, and for at least 48 hours after discontinuing study medication. Protocol Amendment A.1AU included the required assessment for Austrian subjects to perform urine pregnancy tests every 4 weeks during the study.
Exclusion Criteria
2. The subject permanently discontinued study drug during the Treatment Phase of the previous study (TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, or TDE-PH-308) due to clinical worsening (as defined in those study protocols) and did not undergo premature termination assessments prior to discontinuing study drug, and/or did not complete all remaining study visits through the final scheduled visit.
3. The subject prematurely discontinued study drug during the Treatment Phase of the previous study due to clinical worsening (as defined in those study protocols), completed premature termination assessments prior to discontinuing study drug, completed all remaining scheduled study visits AND received oral treprostinil during the Treatment Phase of the previous study (TDE PH-202, TDE-PH-203, TDE-PH-301, TDE-PH-302, or TDE PH-308). Subjects enrolled in Study TDE-PH-202 who were randomized into the individual maximum tolerated dose (iMTD) group who clinically worsened could not participate. Subjects who permanently discontinued study drug during the 12-week Treatment Phase due to treatment-related AEs were not eligible even if they completed all remaining scheduled study visits. Subjects who permanently discontinued study drug during the 12 week Treatment Phase and did not undergo premature termination assessments prior to discontinuing study drug and/or who did not complete all remaining study visits through the Week 12 visit were also not eligible.
4. The subject developed any concurrent illness or condition during the conduct of the previous study, including but not restricted to: sleep apnea, chronic renal insufficiency, anemia, uncontrolled systemic hypertension, or left sided heart disease, unless their physician felt that entry into this study would not be detrimental to their overall health.
12 Years
ALL
No
Sponsors
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United Therapeutics
INDUSTRY
Responsible Party
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Locations
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The Kirklin Clinic
Birmingham, Alabama, United States
Arizona Pulmonary Specialists, Ltd.
Phoenix, Arizona, United States
Mayo Clinic Phoenix
Phoenix, Arizona, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
University Medical Center
Tucson, Arizona, United States
University of Arizona Clinical and Translational Science (CATS) Research Center
Tucson, Arizona, United States
University of California, San Francisco-Fresno
Fresno, California, United States
West Los Angeles VA Healthcare Center
Los Angeles, California, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
UC Davis Medical Center
Sacramento, California, United States
UCSD Medical Center
San Diego, California, United States
University of California San Francisco Medical Center
San Francisco, California, United States
Stanford University, Pulmonary and Critical Care Medicine
Stanford, California, United States
Harbor-UCLA Medical Center
Torrance, California, United States
The Children's Hospital
Aurora, Colorado, United States
University of Colorado Health Science Center
Aurora, Colorado, United States
University of Florida College of Medicine Jacksonville
Jacksonville, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
The Emory Clinic
Atlanta, Georgia, United States
The University of Chicago Hospitals
Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Kentuckiana Pulmonary Associates
Louisville, Kentucky, United States
Alexandria Cardiology Clinic
Alexandria, Louisiana, United States
Maine Medical Center
Portland, Maine, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Johns Hopkins Outpatient Center
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Brigham and Woman's Hospital
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Winthrop University Hospital
Mineola, New York, United States
Columbia University Medical Center
New York, New York, United States
Mary Parkes Center
Rochester, New York, United States
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
The Carl and Ethyl Linder Center for Research and Education at the Christ Church
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
The University of Toledo Medical Center
Toledo, Ohio, United States
Legacy Pulmonary Clinic
Portland, Oregon, United States
Oregon Health and Sciences University
Portland, Oregon, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Texas Medical School
Houston, Texas, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Aurora Cardiovascular Services
Milwaukee, Wisconsin, United States
The Prince Charles Hospital
Chermside West, , Australia
Heart/Lung Transplant Unit - St. Vincent's Hospital
Darlinghurst, , Australia
The Alfred Hospital
Melbourne, , Australia
Royal Perth Hospital
Perth, , Australia
Medizininische Universitaet Wien
Vienna, , Austria
Universitaetsklinik für Innere Medizin Innsbruck
Vienna, , Austria
Medical University Graz
Wein, , Austria
Department of Cardiology Erasme University Hospital
Brussels, , Belgium
University Hospital Gasthuisberg
Leuven, , Belgium
Peter Lougheed Centre
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Vancouver Coastal Health Authority Vancouver General Hospital
Vancouver, British Columbia, Canada
Toronto General Hospital
Toronto, Ontario, Canada
London Health Sciences Center Victoria Hospital
Toronto, Ontario, Canada
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, Canada
Beijing Shijitan Hospital, Cadres Respiratory Department
Beijing, , China
Peking Union Medical College Hospital, Respiratory Medicine Department
Beijing, , China
Shanghai Pulmonary Hospital, Respiratory Medicine Department
Shanghai, , China
Service Chirurgie Thoracique, Hôpital Haut Levêque
Pessac, Pessac Cedex, France
PMAC, Clinique de Pneumologie
Bernin, , France
Centre d'Investigation Clinique Hôpital La Cavale Blanche - CHU Brest
Brest, , France
Hospital Antoine Beclere
Clamart, , France
Hospital Claude Huriez
Lille, , France
Hôpital Louis Pradel
Lyon, , France
CHU Arnaud de Villeneuve - Service maladies respiratoires
Montpellier, , France
Service de Pneumologie Centre de Competence pour l'HTAP- Pole des Voies Respiratoires Hôpital Larrey
Toulouse, , France
Universitätsklinikum Dresden Abtl. Pneumologie
Dresden, , Germany
University Hospital Greifswald
Greifswald, , Germany
DRK Kliniken Berlin Köpenick
Hamburg, , Germany
Universitatsklinikum Hamburg Eppendorf
Hamburg, , Germany
Universitätsklinkium Köln Klinik III für Innere Medizin
Hamburg, , Germany
Zentrum für Lungenhochdruck Thoraxklinik am Universitätsklinikum Heidelberg
Hamburg, , Germany
Medizinische Hochschule Hannover (MHH)
Hanover, , Germany
Dept. of Internal Medicine III University Heidelberg
Heidelberg, , Germany
Care Institute of Medical Sciences
Ahmedabad, Gujarat, India
Narayana Hrudayalaya Hospitals
Bangalore, Karnataka, India
Asian Heart Institute & Research Centre Pvt. Ltd.
Mumbai, Maharashtra, India
Poona Hospital and Research Centre
Pune, Maharashtra, India
Life Care Institute of Medical Sciences & Research
Ahmedabad, , India
Sri Ramachandra Medical College & Research Institute
Chennai, , India
G. Kuppuswamy Naidu Memorial Hospital
Coimbatore, , India
PRIME Hospitals
Hyderabad, , India
Sir Ganga Ram Hospital
New Delhi, , India
Ruby Hall Clinic
Pune, , India
Queen's NRI Hospital
Visakhapatnam, , India
Pulmonary Hypertension Unit Centre for Lung Health Mater Misericordiae University Hospital
Dublin, , Ireland
Rambam Medical Center
Haifa, , Israel
The Lady Davis Carmel Medical Center
Haifa, , Israel
Hadassah Hebrew University Medical Center
Jerusalem, , Israel
Pulmonary Institute Rabin Medical Center (Belinson Kampus)
Petah Tikva, , Israel
Pulmonary Institute Chaim Sheba Medical Center
Ramat Gan, , Israel
Policlinico S. Orsola Malpighi - Università degli studi di Bologna
Bologna, , Italy
Azienda Ospedaliera di Rilievo Nazionale Monaldi - Cotugno-CTO Cardiologia S.U.N.
Naples, , Italy
Azienda Ospedaliera di Rilievo Nazionale Monaldi - Cotugno-CTO Cardiologia S.U.N.
Napoli, , Italy
Dipartimento di Scienze Cardiovascolari, Respiratorie e Morfologiche
Rome, , Italy
Instituto Nacional de Cardiologia
Mexico City, , Mexico
Hospital Universitario de la UANL
Monterrey, , Mexico
Unidad de Investigacion Clinica en Medicina S.C.
Monterrey, , Mexico
Radboud University Nijmegen Medical Center
Amsterdam, , Netherlands
VU Medish Centrum
Amsterdam, , Netherlands
Klinika Chorób Serca i Naczyń, Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow, , Poland
Europejskie Centrum Zdrowia Otwock
Warsaw, , Poland
Oddzial Kardiologiczny
Wroclaw, , Poland
Servico de Cardiologia Hospital de Santa Marta
Lisbon, , Portugal
Auxilio Mutuo Hospital CardioPulmonary Research Center
Guaynabo, , Puerto Rico
Hospital Clínic I Provincial
Barcelona, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Skane University Hospital
Lund, , Sweden
Papworth Hospital
Cambridge, , United Kingdom
Papworth Hospital NHS Foundation Trust
Glasgow, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Freeman Hospital
Newcastle, , United Kingdom
Royal Hallamshire Hospital
Sheffield, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TDE-PH-304
Identifier Type: -
Identifier Source: org_study_id
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