At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Beraprost Sodium 314d Modified Release Tablets and Placebo for Pulmonary Arterial Hypertension. Completed, enrolled 273 participants across 75 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Available as 15 μg tablets for oral, 1 or 2 tablets four times daily (QID) administration
Placebo tablets, which are identical in size and appearance to those containing BPS-314d-MR