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An Open-Label Extension Trial of UT-15C Sustained-release (SR) in Subjects With Pulmonary Arterial Hypertension (FREEDOM-EXT)

Primary Purpose

Pulmonary Arterial Hypertension

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Oral Treprostinil
Sponsored by
United Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The subject remained on study drug and completed all assessments 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) OR the subject permanently discontinued study drug during the Treatment Phase of the previous study due to clinical worsening (as defined in the protocol of the previous study), completed premature termination assessments prior to discontinuing study drug, completed all remaining scheduled study visits, AND received placebo during the Treatment Phase of the previous studies OR the subject was randomized into Group 1 or Group 2 in Study TDE PH 202, permanently discontinued study drug during the 12-week Treatment Phase due to clinical worsening, completed all premature termination assessments prior to discontinuing study drug, and completed all remaining scheduled study visits and assessments (with the exception of the hemodynamic measurements) through Week 12. Such subjects should have started treatment with oral treprostinil in the open-label study at 0.25 mg twice daily (BID).
  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:

  1. The subject permanently discontinued study drug during the previous study (TDE PH 202, TDE-PH-203, TDE PH 205, TDE-PH-301, TDE-PH-302, or TDE PH 308) due to treatment-related adverse events (AEs).
  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.

Sites / Locations

  • The Kirklin Clinic
  • Arizona Pulmonary Specialists, Ltd.
  • Mayo Clinic Phoenix
  • St. Joseph's Hospital and Medical Center
  • University Medical Center
  • University of Arizona Clinical and Translational Science (CATS) Research Center
  • University of California, San Francisco-Fresno
  • West Los Angeles VA Healthcare Center
  • David Geffen School of Medicine at UCLA
  • UC Davis Medical Center
  • UCSD Medical Center
  • University of California San Francisco Medical Center
  • Stanford University, Pulmonary and Critical Care Medicine
  • Harbor-UCLA Medical Center
  • The Children's Hospital
  • University of Colorado Health Science Center
  • University of Florida College of Medicine Jacksonville
  • Cleveland Clinic Florida
  • The Emory Clinic
  • The University of Chicago Hospitals
  • University of Iowa Hospitals and Clinics
  • University of Kansas Medical Center
  • Kentuckiana Pulmonary Associates
  • Alexandria Cardiology Clinic
  • Maine Medical Center
  • University of Maryland Medical Center
  • Johns Hopkins Outpatient Center
  • Tufts Medical Center
  • Brigham and Woman's Hospital
  • University of Michigan Health System
  • University of Minnesota Medical Center, Fairview
  • Mayo Clinic
  • Washington University School of Medicine
  • University of Nebraska Medical Center
  • Newark Beth Israel Medical Center
  • Winthrop University Hospital
  • Columbia University Medical Center
  • Mary Parkes Center
  • University of North Carolina Hospitals
  • Duke University Medical Center
  • The Carl and Ethyl Linder Center for Research and Education at the Christ Church
  • University of Cincinnati
  • University Hospitals of Cleveland
  • Cleveland Clinic
  • Ohio State University
  • The University of Toledo Medical Center
  • Legacy Pulmonary Clinic
  • Oregon Health and Sciences University
  • Hospital of the University of Pennsylvania
  • Allegheny General Hospital
  • UPMC Presbyterian Hospital
  • Medical University of South Carolina
  • Vanderbilt University Medical Center
  • UT Southwestern Medical Center
  • Baylor College of Medicine
  • University of Texas Medical School
  • The University of Texas Health Science Center at San Antonio
  • Intermountain Medical Center
  • Inova Fairfax Hospital
  • University of Washington Medical Center
  • Aurora Cardiovascular Services
  • The Prince Charles Hospital
  • Heart/Lung Transplant Unit - St. Vincent's Hospital
  • The Alfred Hospital
  • Royal Perth Hospital
  • Medical University Graz
  • Medizininische Universitaet Wien
  • Universitaetsklinik für Innere Medizin Innsbruck
  • Department of Cardiology Erasme University Hospital
  • University Hospital Gasthuisberg
  • Peter Lougheed Centre
  • University of Alberta Hospital
  • Vancouver Coastal Health Authority Vancouver General Hospital
  • Toronto General Hospital
  • London Health Sciences Center Victoria Hospital
  • Sir Mortimer B. Davis Jewish General Hospital
  • Beijing Shijitan Hospital, Cadres Respiratory Department
  • Peking Union Medical College Hospital, Respiratory Medicine Department
  • Shanghai Pulmonary Hospital, Respiratory Medicine Department
  • Service Chirurgie Thoracique, Hôpital Haut Levêque
  • PMAC, Clinique de Pneumologie
  • Centre d'Investigation Clinique Hôpital La Cavale Blanche - CHU Brest
  • Hospital Antoine Beclere
  • Hospital Claude Huriez
  • Hôpital Louis Pradel
  • CHU Arnaud de Villeneuve - Service maladies respiratoires
  • Service de Pneumologie Centre de Competence pour l'HTAP- Pole des Voies Respiratoires Hôpital Larrey
  • Universitätsklinikum Dresden Abtl. Pneumologie
  • University Hospital Greifswald
  • DRK Kliniken Berlin Köpenick
  • Universitatsklinikum Hamburg Eppendorf
  • Universitätsklinkium Köln Klinik III für Innere Medizin
  • Zentrum für Lungenhochdruck Thoraxklinik am Universitätsklinikum Heidelberg
  • Medizinische Hochschule Hannover (MHH)
  • Dept. of Internal Medicine III University Heidelberg
  • Care Institute of Medical Sciences
  • Narayana Hrudayalaya Hospitals
  • Asian Heart Institute & Research Centre Pvt. Ltd.
  • Poona Hospital and Research Centre
  • Life Care Institute of Medical Sciences & Research
  • Sri Ramachandra Medical College & Research Institute
  • G. Kuppuswamy Naidu Memorial Hospital
  • PRIME Hospitals
  • Sir Ganga Ram Hospital
  • Ruby Hall Clinic
  • Queen's NRI Hospital
  • Pulmonary Hypertension Unit Centre for Lung Health Mater Misericordiae University Hospital
  • Rambam Medical Center
  • The Lady Davis Carmel Medical Center
  • Hadassah Hebrew University Medical Center
  • Pulmonary Institute Rabin Medical Center (Belinson Kampus)
  • Pulmonary Institute Chaim Sheba Medical Center
  • Policlinico S. Orsola Malpighi - Università degli studi di Bologna
  • Azienda Ospedaliera di Rilievo Nazionale Monaldi - Cotugno-CTO Cardiologia S.U.N.
  • Azienda Ospedaliera di Rilievo Nazionale Monaldi - Cotugno-CTO Cardiologia S.U.N.
  • Dipartimento di Scienze Cardiovascolari, Respiratorie e Morfologiche
  • Instituto Nacional de Cardiologia
  • Hospital Universitario de la UANL
  • Unidad de Investigacion Clinica en Medicina S.C.
  • Radboud University Nijmegen Medical Center
  • VU Medish Centrum
  • Klinika Chorób Serca i Naczyń, Krakowski Szpital Specjalistyczny im. Jana Pawla II
  • Europejskie Centrum Zdrowia Otwock
  • Oddzial Kardiologiczny
  • Servico de Cardiologia Hospital de Santa Marta
  • Auxilio Mutuo Hospital CardioPulmonary Research Center
  • Hospital Clínic I Provincial
  • Hospital Vall d'Hebron
  • Hospital 12 de Octubre
  • Skane University Hospital
  • Papworth Hospital
  • Papworth Hospital NHS Foundation Trust
  • Royal Free Hospital
  • Freeman Hospital
  • Royal Hallamshire Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oral Treprostinil

Arm Description

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

Outcomes

Primary Outcome Measures

Change in Exercise Capacity at Month 12
Assess the effect of continued therapy with oral treprostinil on exercise capacity as assessed by the change from Baseline in 6-Minute Walk Test (6MWT) after 1 year of treatment. The 6MWT is the clinical standard for assessing subject functional status in the treatment of PAH and has been considered an objective measure of subject functional status by the American Thoracic Society. The distance a subject can walk in 6 minutes is recorded in meters.

Secondary Outcome Measures

Full Information

First Posted
December 4, 2009
Last Updated
April 14, 2021
Sponsor
United Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01027949
Brief Title
An Open-Label Extension Trial of UT-15C Sustained-release (SR) in Subjects With Pulmonary Arterial Hypertension
Acronym
FREEDOM-EXT
Official Title
An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 16, 2007 (Actual)
Primary Completion Date
February 12, 2020 (Actual)
Study Completion Date
February 12, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
This study provided/continued to provide oral treprostinil (UT-15C SR; treprostinil diethanolamine) to eligible subjects who participated in Studies TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, and TDE-PH-308. The study assessed the long term safety of oral treprostinil and the effect of continued treatment with oral treprostinil on exercise capacity after 1 year of treatment.
Detailed Description
This was an international, multicenter, open-label study designed to provide oral treprostinil for eligible subjects who participated in Studies TDE-PH-301, TDE-PH-302, TDE-PH-308, TDE-PH-202, TDE PH 203, and TDE-PH-205. Subjects randomly allocated to receive oral treprostinil in Studies TDE-PH-301, TDE-PH-302, or TDE-PH-308 and enrolled in this open-label study completed visits at Months 6, 12, 24, 36, and yearly visits thereafter. Subjects randomly allocated to receive placebo in Studies TDE-PH-301, TDE-PH-302, or TDE-PH-308 completed visits at Months 3, 6, 12, 24, 36, and yearly visits thereafter. Subjects that transitioned from Studies TDE-PH-202, TDE-PH-203, and TDE-PH-205 (that had an open-label study design) followed the regimen for subjects receiving oral treprostinil. A 6-Minute Walk Test (6MWT) and Borg dyspnea score were conducted at the visit which occurred 12 months after the subject's first exposure to oral treprostinil. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Oral Treprostinil
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Oral Treprostinil
Other Intervention Name(s)
Treprostinil diethanolamine, treprostinil diolamine, UT-15C
Intervention Description
Oral sustained release tablet, twice or thrice daily. Open label study with active drug, no other intervention arms.
Primary Outcome Measure Information:
Title
Change in Exercise Capacity at Month 12
Description
Assess the effect of continued therapy with oral treprostinil on exercise capacity as assessed by the change from Baseline in 6-Minute Walk Test (6MWT) after 1 year of treatment. The 6MWT is the clinical standard for assessing subject functional status in the treatment of PAH and has been considered an objective measure of subject functional status by the American Thoracic Society. The distance a subject can walk in 6 minutes is recorded in meters.
Time Frame
From First Visit (Visit 1) to Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject remained on study drug and completed all assessments 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) OR the subject permanently discontinued study drug during the Treatment Phase of the previous study due to clinical worsening (as defined in the protocol of the previous study), completed premature termination assessments prior to discontinuing study drug, completed all remaining scheduled study visits, AND received placebo during the Treatment Phase of the previous studies OR the subject was randomized into Group 1 or Group 2 in Study TDE PH 202, permanently discontinued study drug during the 12-week Treatment Phase due to clinical worsening, completed all premature termination assessments prior to discontinuing study drug, and completed all remaining scheduled study visits and assessments (with the exception of the hemodynamic measurements) through Week 12. Such subjects should have started treatment with oral treprostinil in the open-label study at 0.25 mg twice daily (BID). The subject voluntarily gave informed consent to participate in the study. 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: The subject permanently discontinued study drug during the previous study (TDE PH 202, TDE-PH-203, TDE PH 205, TDE-PH-301, TDE-PH-302, or TDE PH 308) due to treatment-related adverse events (AEs). 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. 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. 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.
Facility Information:
Facility Name
The Kirklin Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Arizona Pulmonary Specialists, Ltd.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Mayo Clinic Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
University Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of Arizona Clinical and Translational Science (CATS) Research Center
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
West Los Angeles VA Healthcare Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
David Geffen School of Medicine at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
UCSD Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
30322
Country
United States
Facility Name
University of California San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Stanford University, Pulmonary and Critical Care Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5351
Country
United States
Facility Name
Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
The Children's Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Health Science Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Florida College of Medicine Jacksonville
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
The Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
The University of Chicago Hospitals
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Kentuckiana Pulmonary Associates
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Alexandria Cardiology Clinic
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins Outpatient Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Brigham and Woman's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Facility Name
University of Minnesota Medical Center, Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1093
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-5300
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
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Mary Parkes Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14643
Country
United States
Facility Name
University of North Carolina Hospitals
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Carl and Ethyl Linder Center for Research and Education at the Christ Church
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0564
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The University of Toledo Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Legacy Pulmonary Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Oregon Health and Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
UPMC Presbyterian Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2650
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Medical School
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84157-7000
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Aurora Cardiovascular Services
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
The Prince Charles Hospital
City
Chermside West
ZIP/Postal Code
4032
Country
Australia
Facility Name
Heart/Lung Transplant Unit - St. Vincent's Hospital
City
Darlinghurst
ZIP/Postal Code
2010
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
ZIP/Postal Code
3004
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
Country
Australia
Facility Name
Medical University Graz
City
Wein
Country
Austria
Facility Name
Medizininische Universitaet Wien
City
Wien
Country
Austria
Facility Name
Universitaetsklinik für Innere Medizin Innsbruck
City
Wien
Country
Austria
Facility Name
Department of Cardiology Erasme University Hospital
City
Brussels
Country
Belgium
Facility Name
University Hospital Gasthuisberg
City
Leuven
Country
Belgium
Facility Name
Peter Lougheed Centre
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 Authority Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
London Health Sciences Center Victoria Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Sir Mortimer B. Davis Jewish General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Beijing Shijitan Hospital, Cadres Respiratory Department
City
Beijing
Country
China
Facility Name
Peking Union Medical College Hospital, Respiratory Medicine Department
City
Beijing
Country
China
Facility Name
Shanghai Pulmonary Hospital, Respiratory Medicine Department
City
Shanghai
Country
China
Facility Name
Service Chirurgie Thoracique, Hôpital Haut Levêque
City
Pessac
State/Province
Pessac Cedex
ZIP/Postal Code
33604
Country
France
Facility Name
PMAC, Clinique de Pneumologie
City
Bernin
Country
France
Facility Name
Centre d'Investigation Clinique Hôpital La Cavale Blanche - CHU Brest
City
Brest
Country
France
Facility Name
Hospital Antoine Beclere
City
Clamart
Country
France
Facility Name
Hospital Claude Huriez
City
Lille Cedex
Country
France
Facility Name
Hôpital Louis Pradel
City
Lyon
Country
France
Facility Name
CHU Arnaud de Villeneuve - Service maladies respiratoires
City
Montpellier cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Service de Pneumologie Centre de Competence pour l'HTAP- Pole des Voies Respiratoires Hôpital Larrey
City
Toulouse
Country
France
Facility Name
Universitätsklinikum Dresden Abtl. Pneumologie
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
University Hospital Greifswald
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
DRK Kliniken Berlin Köpenick
City
Hamburg
Country
Germany
Facility Name
Universitatsklinikum Hamburg Eppendorf
City
Hamburg
Country
Germany
Facility Name
Universitätsklinkium Köln Klinik III für Innere Medizin
City
Hamburg
Country
Germany
Facility Name
Zentrum für Lungenhochdruck Thoraxklinik am Universitätsklinikum Heidelberg
City
Hamburg
Country
Germany
Facility Name
Medizinische Hochschule Hannover (MHH)
City
Hannover
Country
Germany
Facility Name
Dept. of Internal Medicine III University Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Care Institute of Medical Sciences
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380054
Country
India
Facility Name
Narayana Hrudayalaya Hospitals
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560034
Country
India
Facility Name
Asian Heart Institute & Research Centre Pvt. Ltd.
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Name
Poona Hospital and Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411030
Country
India
Facility Name
Life Care Institute of Medical Sciences & Research
City
Ahmedabad
ZIP/Postal Code
380054
Country
India
Facility Name
Sri Ramachandra Medical College & Research Institute
City
Chennai
Country
India
Facility Name
G. Kuppuswamy Naidu Memorial Hospital
City
Coimbatore
Country
India
Facility Name
PRIME Hospitals
City
Hyderabad
ZIP/Postal Code
500038
Country
India
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Ruby Hall Clinic
City
Pune
Country
India
Facility Name
Queen's NRI Hospital
City
Visakhapatnam
Country
India
Facility Name
Pulmonary Hypertension Unit Centre for Lung Health Mater Misericordiae University Hospital
City
Dublin
Country
Ireland
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
The Lady Davis Carmel Medical Center
City
Haifa
Country
Israel
Facility Name
Hadassah Hebrew University Medical Center
City
Jerusalem
Country
Israel
Facility Name
Pulmonary Institute Rabin Medical Center (Belinson Kampus)
City
Petah Tiqva
Country
Israel
Facility Name
Pulmonary Institute Chaim Sheba Medical Center
City
Ramat Gan
Country
Israel
Facility Name
Policlinico S. Orsola Malpighi - Università degli studi di Bologna
City
Bologna
Country
Italy
Facility Name
Azienda Ospedaliera di Rilievo Nazionale Monaldi - Cotugno-CTO Cardiologia S.U.N.
City
Naples
Country
Italy
Facility Name
Azienda Ospedaliera di Rilievo Nazionale Monaldi - Cotugno-CTO Cardiologia S.U.N.
City
Napoli
Country
Italy
Facility Name
Dipartimento di Scienze Cardiovascolari, Respiratorie e Morfologiche
City
Rome
Country
Italy
Facility Name
Instituto Nacional de Cardiologia
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Hospital Universitario de la UANL
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Unidad de Investigacion Clinica en Medicina S.C.
City
Monterrey
ZIP/Postal Code
64718
Country
Mexico
Facility Name
Radboud University Nijmegen Medical Center
City
Amsterdam
Country
Netherlands
Facility Name
VU Medish Centrum
City
Amsterdam
Country
Netherlands
Facility Name
Klinika Chorób Serca i Naczyń, Krakowski Szpital Specjalistyczny im. Jana Pawla II
City
Kraków
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Europejskie Centrum Zdrowia Otwock
City
Warsaw
Country
Poland
Facility Name
Oddzial Kardiologiczny
City
Wroclaw
ZIP/Postal Code
51-124
Country
Poland
Facility Name
Servico de Cardiologia Hospital de Santa Marta
City
Lisbon
Country
Portugal
Facility Name
Auxilio Mutuo Hospital CardioPulmonary Research Center
City
Guaynabo
ZIP/Postal Code
00968
Country
Puerto Rico
Facility Name
Hospital Clínic I Provincial
City
Barcelona
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Skane University Hospital
City
Lund
ZIP/Postal Code
SE 22185
Country
Sweden
Facility Name
Papworth Hospital
City
Cambridge
Country
United Kingdom
Facility Name
Papworth Hospital NHS Foundation Trust
City
Glasgow
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

An Open-Label Extension Trial of UT-15C Sustained-release (SR) in Subjects With Pulmonary Arterial Hypertension

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