Beraprost-314d Added-on to Tyvaso® (BEAT)



Status:Active, not recruiting
Conditions:High Blood Pressure (Hypertension), High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:1/5/2019
Start Date:May 2013
End Date:March 2019

Use our guide to learn which trials are right for you!

A Multicenter, Double-blind, Randomized, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of Oral BPS-314d-MR added-on to Treprostinil, Inhaled (Tyvaso®) in Subjects With Pulmonary Arterial Hypertension

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.


Inclusion Criteria

The following are inclusion criteria to be enrolled in this study:

1. Male or female, age 18 to 80 years (inclusive).

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.

Exclusion Criteria

Patients who meet any of the following criteria will be excluded from the study:

1. Pregnant or lactating.

2. Has previous experience with beraprost or BPS-314d (i.e., BPS-IR, BPS-MR or BPS-314d-
MR).

3. PAH related to any condition not covered under inclusion criteria, including but not
limited to pulmonary venous hypertension, pulmonary veno-occlusive disease, pulmonary
capillary hemangiomatosis, or chronic thromboembolic pulmonary hypertension.

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.
We found this trial at
70
sites
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Terry Fortin, MD
Phone: 919-684-6237
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Micah Fisher, MD
Phone: 404-727-2011
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Robert Bourge, MD
Phone: 205-975-9964
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Aaron Waxman, MD
Phone: 617-525-9731
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
?
mi
from
Boston, MA
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: H. James Ford, MD
Phone: 919-966-2531
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Hassan Alnuaimat, MD
Phone: 352-273-8990
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Linda Cadaret, MD
Phone: 319-384-8005
University of Iowa With just over 30,000 students, the University of Iowa is one of...
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Principal Investigator: Charles Burger, MD
Phone: 904-953-2255
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Los Angeles, California 90095
310-825-4321
Principal Investigator: Rajan Saggar, MD
Phone: 310-794-3299
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
305 1st Avenue # Dazian 7
New York, New York 10003
(212) 420-2806
Principal Investigator: Roxana Sulica, MD
Phone: 212-844-8824
Beth Israel Med Ctr The physicians and staff of Mount Sinai Beth Israel's Heart Institute...
?
mi
from
New York, NY
Click here to add this to my saved trials
1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Principal Investigator: Radha Gopalan, MD
Phone: 917-501-5255
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
?
mi
from
New York, NY
Click here to add this to my saved trials
22 Bramhall St
Portland, Maine 04102
(207) 662-0111
Principal Investigator: Joel Wirth, MD
Phone: 207-662-6550
Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
?
mi
from
Portland, ME
Click here to add this to my saved trials
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Akram Khan, MD
Phone: 503-494-6994
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
?
mi
from
Portland, OR
Click here to add this to my saved trials
593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: James Klinger, MD
Phone: 401-444-4961
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
?
mi
from
Providence, RI
Click here to add this to my saved trials
1000 W Carson St
Torrance, California 90502
Principal Investigator: Ronald Oudiz, MD
Phone: 310-222-3560
?
mi
from
Torrance, CA
Click here to add this to my saved trials
2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Principal Investigator: Franck Rahaghi, MD
Phone: 954-659-6213
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
?
mi
from
Weston, FL
Click here to add this to my saved trials
47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Principal Investigator: Boris Medarov, MD
Phone: 518-262-1542
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
?
mi
from
Albany, NY
Click here to add this to my saved trials
Anderson, South Carolina 29621
Principal Investigator: Charles Thompson, MD
Phone: 864-965-0190
?
mi
from
Anderson, SC
Click here to add this to my saved trials
Atlanta, Georgia 30342
Principal Investigator: Paul Boyce, MD
Phone: 404-236-8113
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: David Badesch, MD
Phone: 720-848-2611
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Austell, Georgia 30106
Principal Investigator: Chad Miller, MD
Phone: 770-745-1404
?
mi
from
Austell, GA
Click here to add this to my saved trials
Baltimore, Maryland 20742
(301) 405-1000
Principal Investigator: Gautam Ramani, MD
Phone: 410-328-6885
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Principal Investigator: Stephen Mathai, MD
Phone: 410-502-4362
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
151 Yitzhack I. Rager Boulevard
Beer-sheva, 84101
?
mi
from
Beer-sheva,
Click here to add this to my saved trials
Beverly Hills, California 90211
Principal Investigator: Antoine Hage, MD
Phone: 310-248-7134
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
Brandon, Florida 33511
Principal Investigator: Robert Dewhurst, MD
Phone: 813-684-6000
?
mi
from
Brandon, FL
Click here to add this to my saved trials
Carmel, Indiana 46032
Principal Investigator: William Harvey, MD
Phone: 317-688-3847
?
mi
from
Carmel, IN
Click here to add this to my saved trials
Celebration, Florida 34747
Principal Investigator: Donald Elton, MD
Phone: 407-507-2615
?
mi
from
Celebration, FL
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Michael Cuttica, MD
Phone: 312-695-2269
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chicago, Illinois 60637
Principal Investigator: Remzi Bag, MD
Phone: 773-834-4141
?
mi
from
Chicago, IL
Click here to add this to my saved trials
2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Jean Elwing, MD
Phone: 513-558-2187
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cleveland, Ohio 44194
Principal Investigator: Robert Schilz, MD
Phone: 216-844-2381
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Namita Sood, MD
Phone: 614-366-2258
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
Principal Investigator: Sonja Bartolome, MD
Phone: 214-645-9730
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Denver, Colorado 80218
Principal Investigator: Nampalli Vijay, MD
Phone: 303-839-7789
?
mi
from
Denver, CO
Click here to add this to my saved trials
Fountain Valley, California 92708
Principal Investigator: David Pham, MD
Phone: 714-887-0400
?
mi
from
Fountain Valley, CA
Click here to add this to my saved trials
Fresno, California
Principal Investigator: Vijay Balasubramanian, MD
Phone: 559-499-6637
?
mi
from
Fresno, CA
Click here to add this to my saved trials
6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Principal Investigator: Myung Park, MD
Phone: 713-441-3916
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
?
mi
from
Houston, TX
Click here to add this to my saved trials
Jacksonville, Florida 32209
Principal Investigator: Abubakr Bajwa, MD
Phone: 904-244-1106
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
Principal Investigator: Hyong Kim, MD
Phone: 858-657-7135
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Lawrenceville, Georgia 30046
Principal Investigator: Paul Weinberg, MD
Phone: 678-942-5986
?
mi
from
Lawrenceville, GA
Click here to add this to my saved trials
Littleton, Colorado 80120
Principal Investigator: Ira Dauber, MD
Phone: 303-703-2124
?
mi
from
Littleton, CO
Click here to add this to my saved trials
Los Angeles, California 90073
Principal Investigator: Shelley Shapiro, MD
Phone: 310-268-4314
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90033
Principal Investigator: Sivagini Ganesh, MD
Phone: 650-678-5324
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40202
Principal Investigator: John W McConnell, MD
Phone: 502-587-8000
?
mi
from
Louisville, KY
Click here to add this to my saved trials
627 South Preston Street
Louisville, Kentucky 40202
Principal Investigator: Shaun Smith, MD
Phone: 502-852-8739
?
mi
from
Louisville, KY
Click here to add this to my saved trials
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
259 1st St
Mineola, New York 11501
(516) 663-0333
Principal Investigator: Shilpa DeSouza, MD
Phone: 516-663-9582
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
?
mi
from
Mineola, NY
Click here to add this to my saved trials
New Haven, Connecticut 06520
Principal Investigator: Wassim Fares, MD
Phone: 203-785-4196
?
mi
from
New Haven, CT
Click here to add this to my saved trials
New Orleans, Louisiana 70115
Principal Investigator: Stacy Mandras, MD
Phone: 504-842-1935
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Erika Berman-Rosenzweig, MD
Phone: 212-305-4436
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
?
mi
from
New York, NY
Click here to add this to my saved trials
Newark, New Jersey 07103
Principal Investigator: Marc Klapholz, MD
Phone: 973-972-6794
?
mi
from
Newark, NJ
Click here to add this to my saved trials
600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Principal Investigator: Michael Eggert, MD
Phone: 757-388-4024
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Oakbrook Terrace, Illinois 60181
Principal Investigator: Maria Rosa Costanzo, MD
Phone: 630-785-2671
?
mi
from
Oakbrook Terrace, IL
Click here to add this to my saved trials
Orlando, Florida 32806
Principal Investigator: James Tarver, MD
Phone: 321-843-1036
?
mi
from
Orlando, FL
Click here to add this to my saved trials
601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Florida Hospital Florida Hospital is one of the country
?
mi
from
Orlando, FL
Click here to add this to my saved trials
1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Michael Scharf, MD
Phone: 215-955-8184
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
Principal Investigator: Michael Mathier, MD
Phone: 412-692-2769
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Principal Investigator: Amresh Raina, MD
Phone: 412-359-3293
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Rancho Mirage, California 92270
Principal Investigator: Learned Gonzales, MD
Phone: 760-778-7799
?
mi
from
Rancho Mirage, CA
Click here to add this to my saved trials
San Antonio, Texas 78229
Principal Investigator: Michael Kwan, MD
Phone: 210-575-3064
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Francisco, California 94143
Principal Investigator: Teresa De Marco, MD
Phone: 415-502-0938
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Santa Barbara, California 93105
Principal Investigator: Jeffrey Sager, MD
Phone: 805-569-7461
?
mi
from
Santa Barbara, CA
Click here to add this to my saved trials
1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
Principal Investigator: Peter Leary, MD
Phone: 206-779-9496
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
South Miami, Florida 33143
Principal Investigator: Javier Jimenez, MD
Phone: 305-999-3301
?
mi
from
South Miami, FL
Click here to add this to my saved trials
450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Roham Zamanian, MD
Phone: 650-725-9861
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
?
mi
from
Stanford, CA
Click here to add this to my saved trials
Syracuse, New York 13210
Principal Investigator: Sherif El Bayadi, MD
Phone: 315-234-0816
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
2401 S. 31st Street
Temple, Texas 76508
254-724-2111
Principal Investigator: Peter Yau, MD
Phone: 254-421-2796
Scott & White Memorial Hospital When Arthur C. Scott, MD, and Raleigh R. White Jr.,...
?
mi
from
Temple, TX
Click here to add this to my saved trials
Toledo, Ohio 43614
Principal Investigator: George Moukarbel, MD
Phone: 419-383-3853
?
mi
from
Toledo, OH
Click here to add this to my saved trials
Troy, Michigan 48085
Principal Investigator: Samuel Allen, MD
Phone: 248-964-8524
?
mi
from
Troy, MI
Click here to add this to my saved trials