Back to resultsFREEDOM - M: Oral Treprostinil as Monotherapy 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 75 years of age, inclusive. Body weight at least 40 kg with a Body Mass Index < 45 PAH that is either idiopathic/heritable; associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); associated with collagen vascular disease; associated with HIV. Previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of PAH. Baseline 6-minute walk distance between 200 and 425 meters, inclusive. Reliable and cooperative with protocol requirements. Exclusion Criteria: Nursing or pregnant. Currently receiving an endothelin receptor antagonist, a phosphodiesterase-5 inhibitor, or prostacyclin within 30 days of Baseline. 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
- Mayo Clinic Arizona
- University of California, San Francisco-Fresno
- West Los Angeles VA Healthcare Center
- UC Davis Medical Center
- Harbor-UCLA Medical Center
- University of Colorado Health Science Center
- University of Florida - Shands Hospital
- Cleveland Clinic Florida
- Emory University Hospital
- University of Chicago Hospitals
- University of Iowa Hospital and Clinics
- Kentuckiana Pulmonary Associates
- Alexandria Cardiology Clinic
- Maine Medical Center
- University of Maryland School of Medicine
- Brigham and Women's Hospital
- Tufts Medical Center
- University of Michigan
- Mayo Clinic
- Washington University Hospital
- Nebraska Medical Center
- Newark Beth Israel Medical Center
- Winthrop University Hospital
- Columbia Presbyterian Medical Center
- Mary M Parkes Center for Asthma, Allergy and Pulmonary Care - University of Rochester
- The Lindner Center
- University of Cincinnati
- The Cleveland Clinic Foundation
- University Hospitals of Cleveland
- Ohio State University
- Legacy Clinic Northwest
- Oregon Health and Science University
- Allegheny General Hospital
- University of Pittsburgh Medical Center
- Medical University of South Carolina
- University of Texas Southwestern
- Baylor College of Medicine, Pulmonary & Critical Care
- University of Texas Health Science Center at San Antonio
- Inova Fairfax Hospital
- University of Washington Medical Center
- Heart Care Associates
- Universitaet Wien
- Hospital Erasme
- University Hospital Gasthuisberg
- Peter Lougheed Centre
- London Health Science Centre
- SMBD Jewish General Hospital
- Beijing Shijitan Hospital
- Peking Union Medical College Hospital
- Shanghai Pulmonary Hospital
- Hospital Antoine Beclere
- PRIME Hospitals
- Care Institute of Medical Science
- Lifecare Institute of Medical Sciences & Research
- Narayana Hrudayalaya Institute of Medical Sciences
- Asian Heart Institute and Research Centre
- Poona Hospital and Research Centre
- Sri Ramachandra Medical College
- G. Kuppuswamy Naidu Memorial Hospital
- K. S. Hospital
- Sir Ganga Ram Hospital
- Ruby Hall Clinic
- Care Hospital
- Hadassah Ein-Kerem Medical Center
- Rabin Medical Center
- Tel Hashomer Medical Center
- Universita degli Studi Bologna
- Instituto Nacional de Cardiologia
- Hospital Universitario UANL
- Unidad de Investigacion Clinica en Medicina (UDICEM)
- VU Medisch Centrum (VUCM)
- Krakowski Szpital Specjalistyczny im. (Kraków Specialist Hospital)
- National Tuberculosis and Lung Disease Research Institute
- Wojewódzki Szpital Specjalistyczny we Wroclawiu (Provincial Specialist Hospital in Wrocław)
- Auxilio Mutuo Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
UT-15C (oral treprositnil)
Placebo
Arm Description
Subjects receive UT-15C (oral treprostinil) twice daily.
Subjects receive placebo (sugar pill) twice daily.
Outcomes
Primary Outcome Measures
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.
The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 12. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians.
Secondary Outcome Measures
Six Minute Walk Distance (6MWD)
Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 11, a time expected to correlate with trough treprostinil concentration.
The six minute walk test was to be conducted 8 to 13 hours after the previous dose of study drug.
The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 11. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians.
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.
The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 8. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians.
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.
The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 4. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians.
Clinical Worsening Assessment
Definition of clinical worsening included patients who met at least one of the following criteria during the 12 weeks of the study:
Death (all causes excluding accident)
Transplantation or atrial septostomy
Clinical deterioration as defined by:
Hospitalization as a result of PAH, or
greater than or equal to 20% decrease in 6MWD from Baseline (or too ill to walk) and a decrease in WHO functional class And
Initiation of new PAH specific therapy (i.e., ERA, PDE5-I, prostacyclin)
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.
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).
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.
Symptoms of PAH
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 12. Severity grade values (i.e., 0, 1, 2, or 3 in increasing severity) were assigned for each symptom.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00325403
Brief Title
FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)
Official Title
A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United Therapeutics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study was an international, multicenter, randomized (2:1 active:placebo), double-blind, placebo-controlled study in subjects with PAH who were NOT currently receiving approved therapy for their PAH. Study visits occurred at 4 week intervals for 12 weeks (with an additional visit at Week 11) with the key measure of efficacy being the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. Two optional substudies were also a part of FREEDOM-M at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 12 and a genetics and biomarkers substudy with blood samples collected at Baseline and Week 12.
Patients who completed all assessments for 12 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
ParticipantInvestigator
Allocation
Randomized
Enrollment
349 (Actual)
8. Arms, Groups, and Interventions
Arm Title
UT-15C (oral treprositnil)
Arm Type
Active Comparator
Arm Description
Subjects receive UT-15C (oral treprostinil) twice daily.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects receive placebo (sugar pill) twice daily.
Intervention Type
Drug
Intervention Name(s)
Oral treprostinil (UT-15C) Sustained Release Tablets
Other Intervention Name(s)
treprostinil diethanolamine
Intervention Description
Sustained release oral tablet, twice daily
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo oral tablet twice daily
Primary Outcome Measure Information:
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.
The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 12. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Six Minute Walk Distance (6MWD)
Description
Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 11, a time expected to correlate with trough treprostinil concentration.
The six minute walk test was to be conducted 8 to 13 hours after the previous dose of study drug.
The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 11. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians.
Time Frame
Baseline and Week 11
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.
The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 8. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians.
Time Frame
Baseline and Week 8
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.
The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 4. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians.
Time Frame
Baseline and Week 4
Title
Clinical Worsening Assessment
Description
Definition of clinical worsening included patients who met at least one of the following criteria during the 12 weeks of the study:
Death (all causes excluding accident)
Transplantation or atrial septostomy
Clinical deterioration as defined by:
Hospitalization as a result of PAH, or
greater than or equal to 20% decrease in 6MWD from Baseline (or too ill to walk) and a decrease in WHO functional class And
Initiation of new PAH specific therapy (i.e., ERA, PDE5-I, prostacyclin)
Time Frame
Baseline and Week 12
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
Baseline and Week 12
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 Week 12
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 Week 12
Title
Symptoms of PAH
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 12. Severity grade values (i.e., 0, 1, 2, or 3 in increasing severity) were assigned for each symptom.
Time Frame
Baseline and Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between 12 and 75 years of age, inclusive.
Body weight at least 40 kg with a Body Mass Index < 45
PAH that is either idiopathic/heritable; associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); associated with collagen vascular disease; associated with HIV.
Previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of PAH.
Baseline 6-minute walk distance between 200 and 425 meters, inclusive.
Reliable and cooperative with protocol requirements.
Exclusion Criteria:
Nursing or pregnant.
Currently receiving an endothelin receptor antagonist, a phosphodiesterase-5 inhibitor, or prostacyclin within 30 days of Baseline.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Laliberte, PharmD
Organizational Affiliation
United Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama-Birmingham
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Arizona Pulmonary Specialist
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
University of California, San Francisco-Fresno
City
Fresno
State/Province
California
Country
United States
Facility Name
West Los Angeles VA Healthcare Center
City
Los Angeles
State/Province
California
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
Country
United States
Facility Name
Harbor-UCLA Medical Center
City
Torrance
State/Province
California
Country
United States
Facility Name
University of Colorado Health Science Center
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
University of Florida - Shands Hospital
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
University of Chicago Hospitals
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
University of Iowa Hospital and Clinics
City
Iowa City
State/Province
Iowa
Country
United States
Facility Name
Kentuckiana Pulmonary Associates
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Alexandria Cardiology Clinic
City
Alexandria
State/Province
Louisiana
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
Country
United States
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
Washington University Hospital
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Nebraska Medical Center
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
Country
United States
Facility Name
Columbia Presbyterian Medical Center
City
New York
State/Province
New York
Country
United States
Facility Name
Mary M Parkes Center for Asthma, Allergy and Pulmonary Care - University of Rochester
City
Rochester
State/Province
New York
Country
United States
Facility Name
The Lindner Center
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Legacy Clinic Northwest
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Baylor College of Medicine, Pulmonary & Critical Care
City
Houston
State/Province
Texas
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Heart Care Associates
City
Milwaukee
State/Province
Wisconsin
Country
United States
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
Peter Lougheed Centre
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
London Health Science Centre
City
London
State/Province
Ontario
Country
Canada
Facility Name
SMBD Jewish General Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Beijing Shijitan Hospital
City
Beijing
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
Country
China
Facility Name
Hospital Antoine Beclere
City
Clamart
Country
France
Facility Name
PRIME Hospitals
City
Hyderbad
State/Province
Andhra Pradesh
Country
India
Facility Name
Care Institute of Medical Science
City
Ahmedabad
State/Province
Gujarat
Country
India
Facility Name
Lifecare Institute of Medical Sciences & Research
City
Ahmedabad
State/Province
Gujarat
Country
India
Facility Name
Narayana Hrudayalaya Institute of Medical Sciences
City
Bangalore
State/Province
Karnataka
Country
India
Facility Name
Asian Heart Institute and Research Centre
City
Parel Mumbai
State/Province
Maharashtra
Country
India
Facility Name
Poona Hospital and Research Centre
City
Pune
State/Province
Maharashtra
Country
India
Facility Name
Sri Ramachandra Medical College
City
Chennai
State/Province
Tamil Nadu
Country
India
Facility Name
G. Kuppuswamy Naidu Memorial Hospital
City
Coimbatore
State/Province
Tamil Nadu
Country
India
Facility Name
K. S. Hospital
City
Chennai, Tamil Nadu
Country
India
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
Country
India
Facility Name
Ruby Hall Clinic
City
Pune
Country
India
Facility Name
Care Hospital
City
Visakhapatnam, Andra Pradesh
Country
India
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
Instituto Nacional de Cardiologia
City
Mexico City
State/Province
DF
Country
Mexico
Facility Name
Hospital Universitario UANL
City
Monterrey
State/Province
NL
Country
Mexico
Facility Name
Unidad de Investigacion Clinica en Medicina (UDICEM)
City
Monterrey
Country
Mexico
Facility Name
VU Medisch Centrum (VUCM)
City
Amsterdam
Country
Netherlands
Facility Name
Krakowski Szpital Specjalistyczny im. (Kraków Specialist Hospital)
City
Kraków
Country
Poland
Facility Name
National Tuberculosis and Lung Disease Research Institute
City
Warsaw
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny we Wroclawiu (Provincial Specialist Hospital in Wrocław)
City
Wroclaw
Country
Poland
Facility Name
Auxilio Mutuo Hospital
City
Guaynabo
Country
Puerto Rico
12. IPD Sharing Statement
Citations:
PubMed Identifier
23307827
Citation
Jing ZC, Parikh K, Pulido T, Jerjes-Sanchez C, White RJ, Allen R, Torbicki A, Xu KF, Yehle D, Laliberte K, Arneson C, Rubin LJ. Efficacy and safety of oral treprostinil monotherapy for the treatment of pulmonary arterial hypertension: a randomized, controlled trial. Circulation. 2013 Feb 5;127(5):624-33. doi: 10.1161/CIRCULATIONAHA.112.124388. Epub 2013 Jan 10.
Results Reference
derived
Links:
URL
http://www.pahstudy.com
Description
FREEDOM Studies Website
Learn more about this trial
FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)
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