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
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.
n/a
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