NCT01908699

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 273 (actual)
• Sponsor: Lung Biotechnology PBC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-05-31
• Primary completion: 2019-02-19
• Completion: 2019-02-19
• First posted: 2013-07-26
• Last updated: 2020-08-03
• Results posted: 2020-02-28

Locations

75 sites across 2 countries: United States, Israel