BPS-314d-MR-PAH-303 (BEAT OLE)



Status:Enrolling by invitation
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 85
Updated:1/6/2019
Start Date:December 10, 2018
End Date:December 2020

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An Open-label Extension of BPS-314d-MR-PAH-302 in Pulmonary Arterial Hypertension Patients

This is a multi-center, open-label study for eligible subjects who were actively
participating in the BPS-314d-MR-PAH-302 study at the time the study was concluded. This OLE
study will evaluate the safety, tolerability and efficacy of long-term treatment of the
esuberaprost sodium tablets (Beraprost Sodium 314d Modified Release tablets) study drug.

Subjects will sign an informed consent to continue treatment for PAH with esuberaprost sodium
tablets in this open-label extension (OLE) study. At the Enrollment Visit for this study,
subjects will begin a blinded transition from the BPS-314d-MR-PAH-302 study to the OLE study
over a 4-week period. The first dose for all subjects in this OLE study will be 2 tablets.
During this blinded transition period, those subjects on active study drug in the
BPS-314d-MR-PAH-302 study will continue with blinded active study drug 4-times daily (QID);
those subjects on placebo study drug will receive one active tablet and one placebo tablet
QID (blinded) during the first 2 weeks and increase to 2 active tablets QID (blinded)
thereafter. After the first dose, the investigator may adjust the dose as medically
warranted. The maximum dose for this study is 30 μg QID with a minimum accepted dose as 15 μg
QID. For the first 4 weeks, contact with the subject should occur weekly to ensure
up-titration to the fixed dose is tolerated and assess adverse events (AEs).

Subjects will return to the clinic at Week 4 to be supplied open-label esuberaprost sodium
tablets and complete protocol specified procedures. At the Week 4 Visit, subjects will be
dosed with two 15 μg tablets (30 μg total), administered orally QID (provided the target dose
is tolerated) or follow the Investigator's (or designee's) directions if adjustment is
needed. Following the Week 4 Visit, each subject will return to the clinic at Months 3, 6, 9,
and 12, and quarterly thereafter for assessments.

At the conclusion of the study or if a subject discontinues the study prematurely, subjects
will return to the clinic for an End-of-Study (EOS) Visit. Subjects will be provided
instructions about down titration off esuberaprost sodium tablets by the investigator.

Inclusion Criteria:

1. Subject must have been actively participating in Study BPS-314d-MR-PAH-302 when the
sponsor concluded that study.

2. In the Investigator's opinion, subject must be competent to understand the information
given in the Institutional Review Board (IRB) or Independent Ethics Committee (IEC)
approved informed consent form (ICF) and must sign the form prior to the initiation of
any study procedures.

3. 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 results 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
BPS-314d-MR-PAH-302 EOS Visit / BPS-314d-MR-PAH-303 Enrollment Visit.

4. Subject must be willing and able to comply with study requirements and restrictions.

Exclusion Criteria:

1. Subject is pregnant or lactating.

2. Subject is scheduled to receive another investigational drug, device, or therapy
during the course of the study.

3. Subject is taking or intends to take any prostacyclin / prostacyclin analog or IP
receptor agonist (EXCEPT FOR treprostinil, inhaled [Tyvaso®]).

4. Subject has any other clinically significant illness or other reason 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.
We found this trial at
44
sites
601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Florida Hospital Florida Hospital is one of the country
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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1000 W Carson St
Torrance, California 90502
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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Albany, New York 12208
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Anderson, South Carolina 29621
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Atlanta, Georgia 30342
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Austell, Georgia 30106
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Beverly Hills, California 90211
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Brandon, Florida 33511
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Denver, Colorado 80218
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Gainesville, FL
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Indianapolis, Indiana 46202
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Indianapolis, IN
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Iowa City, IA
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La Jolla, CA
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Littleton, Colorado 80120
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Los Angeles, California 90095
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Los Angeles, California 90073
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New Orleans, Louisiana 70121
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New York, New York 10029
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Norfolk, VA
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Petah Tikva, 49100
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Santa Barbara, California 93102
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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South Miami, Florida 33143
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Stanford, California 94305
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2401 S. 31st Street
Temple, Texas 76508
254-724-2111
Scott & White Memorial Hospital When Arthur C. Scott, MD, and Raleigh R. White Jr.,...
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2801 W. Bancroft
Toledo, Ohio 43606
419.530.4636
University of Toledo The University of Toledo is one of 14 state universities in Ohio....
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Troy, Michigan 48085
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Westminster, California 92683
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