Back to resultsFREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH)
Primary Purpose
Pulmonary Hypertension
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Oral treprostinil (UT-15C) sustained release tablets
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Hypertension focused on measuring Pulmonary Arterial Hypertension
Eligibility Criteria
Inclusion Criteria: Between 12 and 70 years of age, inclusive. Body weight at least 45 kg (approximately 100 pounds). PAH that is either idiopathic/heritable (including PAH associated with appetite suppressant/toxin use); PAH associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); PAH associated with collagen vascular disease; or PAH associated with HIV. Baseline 6-minute walk distance between 150 and 450 meters, inclusive. Currently receiving an approved endothelin receptor antagonist and/or an approved phosphodiesterase-5 inhibitor for at least 90 days and on a stable dose for at least the last 30 days. Previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of PAH. Reliable and cooperative with protocol requirements. Exclusion Criteria: Nursing or pregnant. Received a prostacyclin within the past 30 days. PAH due to conditions other than noted in the above inclusion criteria. History of uncontrolled sleep apnea, renal insufficiency, anemia, left sided heart disease, uncontrolled systemic hypertension, or parenchymal lung disease. Use of an investigational drug within 30 days of Baseline.
Sites / Locations
- University of Alabama-Birmingham
- Arizona Pulmonary Specialist
- University of Arizona Health Science Center
- West Los Angeles VA Healthcare Center
- Stanford University, Pulmonary and Critical Care
- UC Davis Medical Center
- University of California-San Francisco
- Harbour-UCLA Medical Center
- The Children's Hospital
- Pulmonary Hypertension Clinic
- University of Chicago
- University of Iowa Health Care
- Maine Medical Center
- University of Maryland School of Medicine
- John's Hopkins Hospital
- Tufts Medical Center
- Massachusetts General Hospital
- University of Michigan
- University of Minnesota
- Mayo Clinic
- Washington University Hospital
- Columbia Presbyterian Medical Center
- Mary M Parkes Center for Asthma, Allergy and Pulmonary Care
- Duke University Medical Center
- University Hospitals of Cleveland
- The Cleveland Clinic Foundation
- Ohio State University
- Legacy Clinic Northwest
- Allegheny General Hospital
- University of Pittsburgh Medical Center
- Medical University of South Carolina
- Vanderbilt University Medical Center
- UT Southwestern
- Baylor College of Medicine, Pulmonary & Critical Care
- The University of Texas Health Science Center at San Antonio
- Intermountain Medical Center
- Inova Transplant Center
- University of Washington Medical Center
- Heart Care Associates
- St. Vincent's Hospital
- The Prince Charles Hospital
- The Alfred Hospital
- Royal Perth Hospital
- Medizinische Universität Innsbruck
- Universitaet Wien
- Hospital Erasme
- University Hospital Gasthuisberg
- Respiratory Research
- Vancouver Coastal Health Respiratory Clinic
- Lab London Health Sciences Center
- Toronto General Hospital
- SMBD Jewish General Hospital
- Hospital Cavale Blanche
- Hospital Antoine Beclere
- Hospital Claude Huriez
- Hôpital Louis Pradel
- Medizinische Hochschule Hannover
- Mater Misericordiae University Hospital Ltd
- Hadassah Ein-Kerem Medical Center
- Rabin Medical Center
- Tel Hashomer Medical Center
- Universita degli Studi Bologna
- Universita "La Sapienza" Roma
- Hospital Vrije Universiteit
- National Tuberculosis and Lung Disease Research Institute
- Hospital Clinic of Barcelona
- Hospital Valle Hebron
- Hospital 12 de Octubre
- Papworth Hospital
- Western Infirmary
- Royal Free Hospital
- Freeman Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active
Placebo Arm
Arm Description
Subjects assigned to active therapy with UT-15C 0.25, 0.5, 1, or 5 mg oral tablets.
Subjects assigned to placebo 0.25, 0.5, 1, or 5 mg oral tablets.
Outcomes
Primary Outcome Measures
Six Minute Walk Distance (6MWD)
Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 16, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).
The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.
Secondary Outcome Measures
Borg Dyspnea Score
The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-minute walk test. The Borg dyspnea score was assessed immediately following the 6-minute walk test. Scores ranged from 0 (for no shortness of breath) to 10 (for greatest shortness of breath ever experienced).
Clinical Worsening Assessment
Definition of clinical worsening required one of the following:
Death (all causes excluding accident)
Transplantation or atrial septostomy
Clinical deterioration as defined by:
Hospitalization as a result of PAH, or
≥ 20% decrease in 6-minute walk distance from Baseline (or too ill to walk) and a decrease in WHO functional class And
Initiation of new PAH specific therapy (i.e., ERA, PDE5I, prostacyclin).
Dyspnea-Fatigue Index
The dyspnea-fatigue index has three components, each rated on a scale of 0 to 4, for the magnitude of the task that evokes dyspnea or fatigue, the magnitude of the pace (or effort) with which the task is performed and the associated functional impairment in general activities. The ratings for each component were added to form an aggregate score, which could range from 0, for the worst condition, to 12, for the best.
World Health Organization Functional Classification for PAH
Class I: Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.
Class II: Patients with pulmonary hypertension resulting in slight limitation of physical activity. These patients are comfortable at rest, but ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.
Class III: Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.
Class IV: Patients with pulmonary hypertension with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may be present even at rest. Discomfort is increased by any physical activity.
Six Minute Walk Distance (6MWD)
Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 12, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).
The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.
Six Minute Walk Distance (6MWD)
Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 8, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).
The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.
Six Minute Walk Distance (6MWD)
Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 4, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).
The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.
Change in Symptoms of PAH From Baseline to Week 16
Defined symptoms of PAH including fatigue, dyspnea, edema, dizziness, syncope, chest pain, and orthopnea were assessed at Baseline prior to starting study drug and during the Treatment Phase at Week 16. Severity grade values (i.e., 0, 1, 2, or 3 in increasing severity) were assigned for each symptom. The outcome data describes the change in severity values from Baseline to Week 16 for each defined symptom of PAH.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00325442
Brief Title
FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH)
Official Title
A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects With Pulmonary Arterial Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
December 2010 (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 was an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who were currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits occurred at 4 week intervals for 16 weeks; the key measure of efficacy was the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. One optional substudy was also a part of FREEDOM-C at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 16.
Patients who completed all assessments for 16-weeks were also eligible to enter an open-label, extension phase study (FREEDOM - EXT).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
Pulmonary Arterial Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
354 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Active Comparator
Arm Description
Subjects assigned to active therapy with UT-15C 0.25, 0.5, 1, or 5 mg oral tablets.
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
Subjects assigned to placebo 0.25, 0.5, 1, or 5 mg oral tablets.
Intervention Type
Drug
Intervention Name(s)
Oral treprostinil (UT-15C) sustained release tablets
Intervention Description
UT-15C 0.25, 0.5, 1, or 5 mg oral tablets by mouth every 12 hours
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 0.25, 0.5, 1, or 5 mg oral tablets by mouth every 12 hours
Primary Outcome Measure Information:
Title
Six Minute Walk Distance (6MWD)
Description
Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 16, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).
The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.
Time Frame
Baseline and 16 Weeks
Secondary Outcome Measure Information:
Title
Borg Dyspnea Score
Description
The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-minute walk test. The Borg dyspnea score was assessed immediately following the 6-minute walk test. Scores ranged from 0 (for no shortness of breath) to 10 (for greatest shortness of breath ever experienced).
Time Frame
Baseline and 16 Weeks
Title
Clinical Worsening Assessment
Description
Definition of clinical worsening required one of the following:
Death (all causes excluding accident)
Transplantation or atrial septostomy
Clinical deterioration as defined by:
Hospitalization as a result of PAH, or
≥ 20% decrease in 6-minute walk distance from Baseline (or too ill to walk) and a decrease in WHO functional class And
Initiation of new PAH specific therapy (i.e., ERA, PDE5I, prostacyclin).
Time Frame
Baseline and 16 Weeks
Title
Dyspnea-Fatigue Index
Description
The dyspnea-fatigue index has three components, each rated on a scale of 0 to 4, for the magnitude of the task that evokes dyspnea or fatigue, the magnitude of the pace (or effort) with which the task is performed and the associated functional impairment in general activities. The ratings for each component were added to form an aggregate score, which could range from 0, for the worst condition, to 12, for the best.
Time Frame
Baseline and 16 Weeks
Title
World Health Organization Functional Classification for PAH
Description
Class I: Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.
Class II: Patients with pulmonary hypertension resulting in slight limitation of physical activity. These patients are comfortable at rest, but ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.
Class III: Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.
Class IV: Patients with pulmonary hypertension with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may be present even at rest. Discomfort is increased by any physical activity.
Time Frame
Week 16
Title
Six Minute Walk Distance (6MWD)
Description
Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 12, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).
The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.
Time Frame
Baseline and 12 weeks
Title
Six Minute Walk Distance (6MWD)
Description
Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 8, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).
The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.
Time Frame
Baseline and 8 weeks
Title
Six Minute Walk Distance (6MWD)
Description
Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 4, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).
The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.
Time Frame
Baseline and 4 weeks
Title
Change in Symptoms of PAH From Baseline to Week 16
Description
Defined symptoms of PAH including fatigue, dyspnea, edema, dizziness, syncope, chest pain, and orthopnea were assessed at Baseline prior to starting study drug and during the Treatment Phase at Week 16. Severity grade values (i.e., 0, 1, 2, or 3 in increasing severity) were assigned for each symptom. The outcome data describes the change in severity values from Baseline to Week 16 for each defined symptom of PAH.
Time Frame
Baseline and 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between 12 and 70 years of age, inclusive.
Body weight at least 45 kg (approximately 100 pounds).
PAH that is either idiopathic/heritable (including PAH associated with appetite suppressant/toxin use); PAH associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); PAH associated with collagen vascular disease; or PAH associated with HIV.
Baseline 6-minute walk distance between 150 and 450 meters, inclusive.
Currently receiving an approved endothelin receptor antagonist and/or an approved phosphodiesterase-5 inhibitor for at least 90 days and on a stable dose for at least the last 30 days.
Previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of PAH.
Reliable and cooperative with protocol requirements.
Exclusion Criteria:
Nursing or pregnant.
Received a prostacyclin within the past 30 days.
PAH due to conditions other than noted in the above inclusion criteria.
History of uncontrolled sleep apnea, renal insufficiency, anemia, left sided heart disease, uncontrolled systemic hypertension, or parenchymal lung disease.
Use of an investigational drug within 30 days of Baseline.
Facility Information:
Facility Name
University of Alabama-Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Arizona Pulmonary Specialist
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
University of Arizona Health Science Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
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
Stanford University, Pulmonary and Critical Care
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California-San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Harbour-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
80218
Country
United States
Facility Name
Pulmonary Hypertension Clinic
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Iowa Health Care
City
Iowa
State/Province
Iowa
ZIP/Postal Code
52242
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 School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
John's Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
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
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Columbia Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Mary M Parkes Center for Asthma, Allergy and Pulmonary Care
City
Rochester
State/Province
New York
ZIP/Postal Code
14643
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Cleveland Clinic Foundation
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
Legacy Clinic Northwest
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh Medical Center
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
Country
United States
Facility Name
UT Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Baylor College of Medicine, Pulmonary & Critical Care
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
84143
Country
United States
Facility Name
Inova Transplant Center
City
Fairfax
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
Heart Care Associates
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
St. Vincent's Hospital
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
The Prince Charles Hospital
City
Brisbane
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
Country
Australia
Facility Name
Medizinische Universität Innsbruck
City
Innsbruck
Country
Austria
Facility Name
Universitaet Wien
City
Wien
Country
Austria
Facility Name
Hospital Erasme
City
Brussels
Country
Belgium
Facility Name
University Hospital Gasthuisberg
City
Leuven
Country
Belgium
Facility Name
Respiratory Research
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Vancouver Coastal Health Respiratory Clinic
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3J5
Country
Canada
Facility Name
Lab London Health Sciences Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
SMBD Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Hospital Cavale Blanche
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
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Facility Name
Mater Misericordiae University Hospital Ltd
City
Dublin
Country
Ireland
Facility Name
Hadassah Ein-Kerem Medical Center
City
Jerusalem
Country
Israel
Facility Name
Rabin Medical Center
City
Petach Tikva
Country
Israel
Facility Name
Tel Hashomer Medical Center
City
Ramat Gan
Country
Israel
Facility Name
Universita degli Studi Bologna
City
Bologna
Country
Italy
Facility Name
Universita "La Sapienza" Roma
City
Rome
Country
Italy
Facility Name
Hospital Vrije Universiteit
City
Amsterdam
Country
Netherlands
Facility Name
National Tuberculosis and Lung Disease Research Institute
City
Warsaw
Country
Poland
Facility Name
Hospital Clinic of Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital Valle Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Papworth Hospital
City
Cambridge
Country
United Kingdom
Facility Name
Western Infirmary
City
Glasgow
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
22628490
Citation
Tapson VF, Torres F, Kermeen F, Keogh AM, Allen RP, Frantz RP, Badesch DB, Frost AE, Shapiro SM, Laliberte K, Sigman J, Arneson C, Galie N. Oral treprostinil for the treatment of pulmonary arterial hypertension in patients on background endothelin receptor antagonist and/or phosphodiesterase type 5 inhibitor therapy (the FREEDOM-C study): a randomized controlled trial. Chest. 2012 Dec;142(6):1383-1390. doi: 10.1378/chest.11-2212.
Results Reference
derived
Learn more about this trial
FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH)
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