Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
273 participants
INTERVENTIONAL
2013-05-31
2019-02-19
Brief Summary
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Patients new to Tyvaso, will enter a run-in period on inhaled treprostinil until 90 days of experience is achieved to ensure drug tolerability before enrolling in the study.
Treatment groups consist of one active and one placebo group. Subjects will be randomly allocated in a 1:1 ratio to one of the two treatment groups.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Beraprost Sodium 314d Modified Release Tablets
Available as 15 μg tablets for oral, 1 or 2 tablets four times daily (QID) administration.
Beraprost Sodium 314d Modified Release Tablets
Available as 15 μg tablets for oral, 1 or 2 tablets four times daily (QID) administration
Placebo
Placebo tablets, which are identical in size and appearance to those containing BPS-314d-MR.
Placebo
Placebo tablets, which are identical in size and appearance to those containing BPS-314d-MR
Interventions
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Beraprost Sodium 314d Modified Release Tablets
Available as 15 μg tablets for oral, 1 or 2 tablets four times daily (QID) administration
Placebo
Placebo tablets, which are identical in size and appearance to those containing BPS-314d-MR
Eligibility Criteria
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Inclusion Criteria
2. Established diagnosis of pulmonary arterial hypertension that is either idiopathic or familial PAH, collagen vascular disease associated PAH, PAH associated with HIV infection, PAH induced by anorexigens/toxins, or PAH associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥1 years).
3. If HIV positive, has a CD4 lymphocyte count ≥200 cells/mm3 within 30 days of Baseline Visit and is receiving current standard of care antiretroviral or other effective medication.
4. At the Screening Visit, WHO functional class III or IV and who have declining or unsatisfactory clinical response to current PAH therapy.
5. At the Baseline Visit, WHO functional class III or IV and who have declining or unsatisfactory clinical response to inhaled treprostinil therapy.
6. Able to walk unassisted (oxygen use allowed).
7. A 6-Minute Walk distance (6MWD) of ≥ 100 meters at the Screening Visit.
8. Previous (within five years prior to the Baseline Visit) right heart cardiac catheterization (RHC) with findings consistent with PAH, specifically mean Pulmonary Arterial Pressure (PAPm) ≥25 mmHg (at rest), Pulmonary Capillary Wedge Pressure (PCWP) (or left ventricular end diastolic pressure) ≤15 mmHg, and Pulmonary Vascular Resistance (PVR) \>3 mmHg/L/min.
9. Echocardiography excluding any clinically significant left heart disease (e.g. left sided valve disease, wall motion abnormality suggesting of myocardial infarction, left ventricular hypertrophy, etc).
10. Pulmonary function tests conducted within 12 months before or during the Screening period to confirm the following:
1. Total lung capacity (TLC) is at least 60% (predicted value) and
2. Forced expiratory volume at one second (FEV1) of at least 50% (predicted value).
11. Subjects receiving additional FDA approved PAH therapies must be stable on their current dose for at least 30 days prior to the Baseline Visit, apart from modification of anticoagulant or diuretic dosages.
12. Must have completed 90 days of uninterrupted inhaled treprostinil treatment and received a stable dose of inhaled treprostinil for at least 30 days prior to Baseline to be eligible for randomization into the study.
13. Women of child-bearing potential (defined as less than 1 year post-menopausal and not surgically sterile) must be practicing abstinence or using two highly effective methods of contraception (defined as a method of birth control that result in a low failure rate, i.e., less than 1% per year, such as approved hormonal contraceptives, barrier methods \[such as a condom or diaphragm\] used with a spermicide, or an intrauterine device). Subject must have a negative pregnancy test at the Screening and Baseline Visits.
14. Willing and able to comply with study requirements and restrictions.
4. History of interstitial lung disease, unless subject has collagen vascular disease and has had pulmonary function testing conducted within 12 months of the Baseline Visit demonstrating a total lung capacity ≥60% of predicted.
5. Has active hemorrhagic condition (e.g., upper digestive tract hemorrhage, hemoptysis, etc), or has a pre-existing condition that, in the Investigator's judgment, may increase the risk for developing hemorrhage during the study (e.g., hemophilia). Transient hemorrhage (e.g., epistaxis, normal menstrual bleeding, gingival bleeding, hemorrhoidal bleeding, etc) will not preclude enrollment.
6. Has received any investigational drug, device or therapy within 30 days prior to the Baseline Visit or is scheduled to receive another investigational drug, device or therapy during the course of the study.
7. Has any musculoskeletal disease or any other disease that would significantly limit ambulation.
8. Has any form of unrepaired or recently repaired (\< 1 year) congenital systemic-to-pulmonary shunt other than patent foramen ovale.
9. Evidence of significant coronary arterial disease with symptoms, such as angina.
10. Left sided myocardial disease as evidenced by left ventricular ejection fraction \< 40%, or shortening fraction \<22%.
11. Has creatinine clearance \<30 (using the Cockroft-Gault formula) or requires hemodialysis.
12. Has Childs-Pugh class C liver cirrhosis.
13. Has had previous atrial septostomy.
14. Any other clinically significant illness or abnormal laboratory values (measured during the Screening period) that, in the opinion of the Investigator, might put the subject at risk of harm during the study or might adversely affect the interpretation of the study data.
15. Anticipated survival less than 1 year due to concomitant disease.
The Sponsor recognizes that the pulmonary hypertension population is complex and diverse. In order to facilitate enrollment of appropriate subjects to this pivotal trial, Investigators are strongly encouraged to contact the medical director or study team to discuss potential study subjects who have comorbid conditions before enrollment into this study. See Appendix 9 for additional details.
No waivers to entry criteria are allowable in this study. Subjects who are initially ineligible for this study may be reassessed for eligibility after consultation with the Sponsor.
Exclusion Criteria
1. Pregnant or lactating.
2. Has previous experience with beraprost or BPS-314d (i.e., BPS-IR, BPS-MR or BPS-314d- MR).
18 Years
80 Years
ALL
No
Sponsors
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Lung Biotechnology PBC
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Cedars-Sinai Medical Center Heart Institute
Beverly Hills, California, United States
Allianz Research Institute Inc.
Fountain Valley, California, United States
University of California San Francisco - Fresno
Fresno, California, United States
University of California - San Diego
La Jolla, California, United States
University of California Los Angeles
Los Angeles, California, United States
Keck Medical Center of USC
Los Angeles, California, United States
Veterans Affairs Greater Los Angeles Healthcare System
Los Angeles, California, United States
Center for Advanced Pulmonary Medicine
Rancho Mirage, California, United States
University of California - San Francisco
San Francisco, California, United States
Cottage Pulmonary Hypertension Center
Santa Barbara, California, United States
Stanford University
Stanford, California, United States
Harbor-UCLA Medical Center
Torrance, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Aurora Denver Cardiology Associates
Denver, Colorado, United States
South Denver Cardiology Associates P.C.
Littleton, Colorado, United States
Yale School of Medicine
New Haven, Connecticut, United States
Bay Area Cardiology Associates, P.A.
Brandon, Florida, United States
Florida Lung, Asthma, and Sleep Institute
Celebration, Florida, United States
University of Florida
Gainesville, Florida, United States
University of Florida College of Medicine
Jacksonville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Florida Hospital
Orlando, Florida, United States
Orlando Health Heart Institute
Orlando, Florida, United States
South Miami Heart Specialists
South Miami, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Emory University
Atlanta, Georgia, United States
Pulmonary & Critical Care of Atlanta
Atlanta, Georgia, United States
Georgia Clinical Research
Austell, Georgia, United States
Gwinnett Biomedical Research
Lawrenceville, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago Medicine
Chicago, Illinois, United States
Advocate Health and Hospitals Corporation
Oakbrook Terrace, Illinois, United States
Indiana University - Health Physicians
Carmel, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Kentuckiana Pulmonary Associates
Louisville, Kentucky, United States
University of Louisville Department of Medicine
Louisville, Kentucky, United States
John Ochsner Heart & Vascular Institute
New Orleans, Louisiana, United States
Maine Medical Center
Portland, Maine, United States
University of Maryland
Baltimore, Maryland, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beaumont Health Systems
Troy, Michigan, United States
Rutgers University Hospital
Newark, New Jersey, United States
Albany Medical College
Albany, New York, United States
Winthrop University Hospital
Mineola, New York, United States
Beth Israel Medical Center
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Pulmonary Health Physicians, PC
Syracuse, New York, United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
University of Toledo Medical Center
Toledo, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Anderson Pharmaceutical Research
Anderson, South Carolina, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Methodist Healthcare Clinical Trials Office
San Antonio, Texas, United States
Scott & White Memorial Hospital
Temple, Texas, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Soroka Medical Center
Beersheba, , Israel
The Lady Davis Carmel Medical Center
Haifa, , Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, , Israel
Rabin Medical Center-Beilinson Campus
Petah Tikva, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Kaplan Medical Center
Rehovot, , Israel
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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BPS-314d-MR-PAH-302
Identifier Type: -
Identifier Source: org_study_id
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