- Pulmonary hypertension
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Phase III Study to Assess the Efficacy and Safety of Oral BPS-314d-MR Added-On to Treprostinil, Inhaled (Tyvaso) in Subjects with Pulmonary Arterial Hypertension (IRB no. 35062)
This study focuses on patients with pulmonary arterial hypertension (PAH). The purpose of the study is to compare the effect of an oral investigational drug called Beraprost Sodium-314d-Modified Release (BPS-314d-MR) to a placebo (sugar pill) when used with an inhaled medication called Tyvaso. Researchers will also assess the safety of the BPS-314d-MR and keep track of changes in exercise ability to determine whether participants' PAH worsens.
In addition, researchers will study a biomarker for heart failure called NT-pro-BNP. A biomarker is a biological molecule found in blood, other body fluids, or tissues that may be a sign of a condition or disease. This biomarker will be used to make decisions on clinical management for disease progression and worsening.
Key Inclusion Criteria:
- 18-80 years old
- Established diagnosis of pulmonary arterial hypertension
- Able to walk unassisted (oxygen use allowed)
Key Exclusion Criteria:
- Pregnant or lactating
- Has previous experience with beraprost or BPS-314d
- PAH related to any condition not covered under detailed inclusion criteria
Antoine Hage, MD