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

Pulmonary Arterial Hypertension Clinical Trial

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

Clinical 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.

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01908699
Study type Interventional
Source Lung Biotechnology PBC
Contact
Status Completed
Phase Phase 3
Start date May 31, 2013
Completion date February 19, 2019
View Details
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