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

NCT01908699 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 273

Last updated 2020-08-03

Study results available
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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.

Conditions

Interventions

DRUG

Beraprost Sodium 314d Modified Release Tablets

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Lung Biotechnology PBC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2019-02-19
Completion
2019-02-19

Countries

  • United States
  • Israel

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01908699 on ClinicalTrials.gov