Beraprost-314d Added-on to Tyvaso® (BEAT)
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Drug: Placebo
- Registration Number
- NCT01908699
- Lead Sponsor
- Lung Biotechnology PBC
- Brief Summary
This is a multicenter, double-blind, randomized, placebo-controlled Phase 3 study, to assess the efficacy and safety of BPS-314d-MR when added-on to inhaled treprostinil (Tyvaso®)in patients with pulmonary arterial hypertension.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 273
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Beraprost Sodium 314d Modified Release Tablets Beraprost Sodium 314d Modified Release Tablets Available as 15 μg tablets for oral, 1 or 2 tablets four times daily (QID) administration. Placebo Placebo Placebo tablets, which are identical in size and appearance to those containing BPS-314d-MR.
- Primary Outcome Measures
Name Time Method Number of Participants That Experienced Clinical Worsening up to 144 weeks The number of participants that experienced a Clinical Worsening event confirmed by Endpoint Adjudication Committee at First Maximum Severity. Clinical Worsening was defined as any of these events following the Baseline visit: Death (all causes); Hospitalization due to worsening PAH; Initiation of a parenteral (infusion or sub-cutaneous) prostacyclin, directly related to worsening PAH; Disease progression; Unsatisfactory long-term clinical response.
The number of participants that experienced clinical worsening is presented; time to clinical worsening data was not measured. Given the rate of clinical worsening overall and the large number of censored observations at the end of the study, the mean survival time estimates were not available for this endpoint.
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline in Borg Dyspnea Score at Week 24 Baseline and Week 24 The Borg dyspnea score was assessed prior to and following the completion of the 6MWT at Week 24. The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6MWT. Scores range from 0 (for the best condition) to 10 (for the worst condition).
Mean Change From Baseline in NT-pro-BNP Levels at Week 24 Baseline and Week 24 Plasma NT-proBNP concentration is a useful biomarker for PAH as it is associated with changes in right heart morphology and function.
Change in WHO Functional Class From Baseline to Week 24 Baseline and Week 24 Change from Baseline in participant clinical status was recorded according to the World Health Organization (WHO) Functional Class. A change from lower to higher functional class (i.e. 'III to IV' or 'II to III') was considered as a deterioration. A change from higher to lower functional class (i.e. 'III to II' or 'II to I') was considered as an improvement. All efficacy results are descriptive; no statistical analysis was conducted.
Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 24 Baseline and Week 24 Area used for the Six Minute Walk Test (6MWT) was pre-measured at 30 meters in length. Rest periods were allowed if patient could no longer continue. If patient needed to rest, he/she could stand or sit and then begin again when rested but the clock continued to run. At the end of 6 minutes, the tester called "stop" while stopping the watch and then measured the distance walked. For purposes of the 6MWT, if patient was assessed at Baseline using oxygen therapy, all future 6MWT were conducted in the same manner.
Number of Participants With TEAEs, Serious TEAEs, Investigations SOC TEAEs, and Serious Investigations SOC TEAEs up to 144 weeks The number of participants experiencing overall Treatment-Emergent Adverse Adverse Events (TEAEs), serious TEAEs, Investigations SOC TEAEs, and serious Investigations SOC TEAEs were reported.Investigations SOC TEAEs were any event categorized within the Investigations System Order Class (SOC) and include adverse events due to physical examinations, vital signs, clinical laboratory parameters, and electrocardiogram findings.
Trial Locations
- Locations (75)
Rutgers University Hospital
🇺🇸Newark, New Jersey, United States
Cottage Pulmonary Hypertension Center
🇺🇸Santa Barbara, California, United States
Pulmonary & Critical Care of Atlanta
🇺🇸Atlanta, Georgia, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, 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
Center for Advanced Pulmonary Medicine
🇺🇸Rancho Mirage, 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
Stanford University
🇺🇸Stanford, California, United States
Harbor-UCLA Medical Center
🇺🇸Torrance, California, 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 College of Medicine
🇺🇸Jacksonville, Florida, United States
Florida Hospital
🇺🇸Orlando, Florida, United States
Orlando Health Heart Institute
🇺🇸Orlando, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
South Miami Heart Specialists
🇺🇸South Miami, Florida, United States
Georgia Clinical Research
🇺🇸Austell, Georgia, United States
Gwinnett Biomedical Research
🇺🇸Lawrenceville, Georgia, United States
University of Chicago Medicine
🇺🇸Chicago, 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
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Beaumont Health Systems
🇺🇸Troy, Michigan, 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
University of North Carolina, Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Pulmonary Health Physicians, PC
🇺🇸Syracuse, New York, United States
University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States
University of Toledo Medical Center
🇺🇸Toledo, Ohio, United States
UPMC Presbyterian Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, 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
The Lady Davis Carmel Medical Center
🇮🇱Haifa, Israel
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Hadassah University Hospital - Ein Kerem
🇮🇱Jerusalem, Israel
Rabin Medical Center-Beilinson Campus
🇮🇱Petach Tikva, Israel
University of California - San Francisco
🇺🇸San Francisco, California, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Methodist Healthcare Clinical Trials Office
🇺🇸San Antonio, Texas, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Soroka Medical Center
🇮🇱Beer-sheva, Israel
Kaplan Medical Center
🇮🇱Rechovot, Israel
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
John Ochsner Heart & Vascular Institute
🇺🇸New Orleans, Louisiana, United States
Albany Medical College
🇺🇸Albany, New York, United States
Advocate Health and Hospitals Corporation
🇺🇸Oakbrook Terrace, Illinois, United States
Scott & White Memorial Hospital
🇺🇸Temple, Texas, United States
Chaim Sheba Medical Center
🇮🇱Ramat-Gan, Israel
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Aurora Denver Cardiology Associates
🇺🇸Denver, Colorado, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States