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Pulmonary Arterial HypertensionPhase 3BEATNCT01908699

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

A Phase 3 study testing Beraprost Sodium 314d Modified Release Tablets in people with Pulmonary Arterial Hypertension, run by Lung Biotechnology PBC at 75 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Pulmonary Arterial Hypertension
What is being tested?
Beraprost Sodium 314d Modified Release Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
273 participants
Where
75 sitesin 2 countries
Study dates
31 May 2013to 19 Feb 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The following are inclusion criteria to be enrolled in this study:
  • Male or female, age 18 to 80 years (inclusive).
  • 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).
  • 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.
  • At the Screening Visit, WHO functional class III or IV and who have declining or unsatisfactory clinical response to current PAH therapy.
  • At the Baseline Visit, WHO functional class III or IV and who have declining or unsatisfactory clinical response to inhaled treprostinil therapy.
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  • Able to walk unassisted (oxygen use allowed).
  • A 6-Minute Walk distance (6MWD) of ≥ 100 meters at the Screening Visit.
  • 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.
  • 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).
  • Pulmonary function tests conducted within 12 months before or during the Screening period to confirm the following:
  • Total lung capacity (TLC) is at least 60% (predicted value) and
  • Forced expiratory volume at one second (FEV1) of at least 50% (predicted value).
  • 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.
  • 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.
  • 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.
  • Willing and able to comply with study requirements and restrictions.

Who cannot join

  • Patients who meet any of the following criteria will be excluded from the study:
  • Pregnant or lactating.
  • Has previous experience with beraprost or BPS-314d (i.e., BPS-IR, BPS-MR or BPS-314d- MR).
  • 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.
  • 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.
  • 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.
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  • 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.
  • Has any musculoskeletal disease or any other disease that would significantly limit ambulation.
  • Has any form of unrepaired or recently repaired (< 1 year) congenital systemic-to-pulmonary shunt other than patent foramen ovale.
  • Evidence of significant coronary arterial disease with symptoms, such as angina.
  • Left sided myocardial disease as evidenced by left ventricular ejection fraction < 40%, or shortening fraction <22%.
  • Has creatinine clearance <30 (using the Cockroft-Gault formula) or requires hemodialysis.
  • Has Childs-Pugh class C liver cirrhosis.
  • Has had previous atrial septostomy.
  • 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.
  • 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.

Trial locations and contacts

75 sites in 2 countries.

75 sites in 2 countries

United States69 sites

  • Albany Medical College

    Albany, New York, 12206

  • Anderson Pharmaceutical Research

    Anderson, South Carolina, 29621

  • Emory University

    Atlanta, Georgia, 30322

  • Pulmonary & Critical Care of Atlanta

    Atlanta, Georgia, 30342

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • Georgia Clinical Research

    Austell, Georgia, 30106

  • University of Maryland

    Baltimore, Maryland, 21201

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21205

  • Cedars-Sinai Medical Center Heart Institute

    Beverly Hills, California, 90211

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Bay Area Cardiology Associates, P.A.

    Brandon, Florida, 33511

  • Indiana University - Health Physicians

    Carmel, Indiana, 46032

  • Florida Lung, Asthma, and Sleep Institute

    Celebration, Florida, 34747

  • University of North Carolina, Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Chicago Medicine

    Chicago, Illinois, 60637

  • University of Cincinnati

    Cincinnati, Ohio, 45627

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • Ohio State University

    Columbus, Ohio, 43221

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Aurora Denver Cardiology Associates

    Denver, Colorado, 80218

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Allianz Research Institute Inc.

    Fountain Valley, California, 92708

  • University of California San Francisco - Fresno

    Fresno, California, 93720

  • University of Florida

    Gainesville, Florida, 32610

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • University of Iowa

    Iowa City, Iowa, 52242

  • University of Florida College of Medicine

    Jacksonville, Florida, 32209

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • University of California - San Diego

    La Jolla, California, 92093

  • Gwinnett Biomedical Research

    Lawrenceville, Georgia, 30046

  • South Denver Cardiology Associates P.C.

    Littleton, Colorado, 80120

  • University of California Los Angeles

    Los Angeles, California, 90024

  • Keck Medical Center of USC

    Los Angeles, California, 90033

  • Veterans Affairs Greater Los Angeles Healthcare System

    Los Angeles, California, 90073

  • Kentuckiana Pulmonary Associates

    Louisville, Kentucky, 40202

  • University of Louisville Department of Medicine

    Louisville, Kentucky, 40202

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Yale School of Medicine

    New Haven, Connecticut, 06510

  • John Ochsner Heart & Vascular Institute

    New Orleans, Louisiana, 70121

  • Beth Israel Medical Center

    New York, New York, 10003

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Rutgers University Hospital

    Newark, New Jersey, 07103

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Advocate Health and Hospitals Corporation

    Oakbrook Terrace, Illinois, 60181

  • Florida Hospital

    Orlando, Florida, 32804

  • Orlando Health Heart Institute

    Orlando, Florida, 32806

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • UPMC Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213

  • Maine Medical Center

    Portland, Maine, 04102

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Center for Advanced Pulmonary Medicine

    Rancho Mirage, California, 92270

  • Methodist Healthcare Clinical Trials Office

    San Antonio, Texas, 78229

  • University of California - San Francisco

    San Francisco, California, 94143

  • Cottage Pulmonary Hypertension Center

    Santa Barbara, California, 93105

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • South Miami Heart Specialists

    South Miami, Florida, 33143

  • Stanford University

    Stanford, California, 94305

  • Pulmonary Health Physicians, PC

    Syracuse, New York, 13210

  • Scott & White Memorial Hospital

    Temple, Texas, 76508

  • University of Toledo Medical Center

    Toledo, Ohio, 43614

  • Harbor-UCLA Medical Center

    Torrance, California, 90502

  • Beaumont Health Systems

    Troy, Michigan, 48085

  • Cleveland Clinic Florida

    Weston, Florida, 33331

Other trials in United States

Israel6 sites

  • Soroka Medical Center

    Beersheba, 84101

  • The Lady Davis Carmel Medical Center

    Haifa, 3436212

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 9112001

  • Rabin Medical Center-Beilinson Campus

    Petah Tikva, 4941492

  • Chaim Sheba Medical Center

    Ramat Gan, 52621

  • Kaplan Medical Center

    Rehovot, 7610001

Other trials in Israel

About this study

Official title: 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.

Being tested
Beraprost Sodium 314d Modified Release Tablets, Placebo
Medical subject headings
Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Beraprost Sodium 314d Modified Release TabletsDrug

    Available as 15 μg tablets for oral, 1 or 2 tablets four times daily (QID) administration

  • PlaceboDrug

    Placebo tablets, which are identical in size and appearance to those containing BPS-314d-MR

Study groups in NCT01908699
Study groupRoleWhat they receive
Beraprost Sodium 314d Modified Release TabletsExperimentalAvailable as 15 μg tablets for oral, 1 or 2 tablets four times daily (QID) administration.
Receives: Drug: Beraprost Sodium 314d Modified Release Tablets
PlaceboExperimentalPlacebo tablets, which are identical in size and appearance to those containing BPS-314d-MR.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants That Experienced Clinical Worsening

    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.

    Measured: up to 144 weeks

Secondary outcomes (5)

  1. Mean Change From Baseline in Borg Dyspnea Score at 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).

    Measured: Baseline and Week 24

  2. Mean Change From Baseline in NT-pro-BNP Levels at Week 24

    Plasma NT-proBNP concentration is a useful biomarker for PAH as it is associated with changes in right heart morphology and function.

    Measured: Baseline and Week 24

  3. Change in WHO Functional Class From Baseline to 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.

    Measured: Baseline and Week 24

  4. Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at 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.

    Measured: Baseline and Week 24

  5. Number of Participants With TEAEs, Serious TEAEs, Investigations SOC TEAEs, and Serious Investigations SOC TEAEs

    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.

    Measured: up to 144 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2013 (estimated)
  2. Study start31 May 2013
  3. Primary completion19 Feb 2019
  4. Study completion19 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
273 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01908699
Sponsor's protocol ID
BPS-314d-MR-PAH-302
Acronym
BEAT
Status last verified
Jul 2020
First submitted
16 Jul 2013
Last updated
3 Aug 2020
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Beraprost Sodium 314d Modified Release Tablets in people with Pulmonary Arterial Hypertension, run by Lung Biotechnology PBC at 75 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants That Experienced Clinical Worsening (time frame: up to 144 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01908699.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.

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