drugset / Trial / NCT03657095

A Study With BPS-314d-MR-PAH-303 in Participants With Pulmonary Arterial Hypertension

NCT03657095 ↗

Phase 3 Terminated 112 enrolled Lung Biotechnology PBC
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a multi-center, open-label study for eligible participants who were actively participating in the BPS-314d-MR-PAH-302 double-blind study (NCT01908699) at the time the study was concluded. This open-label extension (OLE) study will evaluate the safety, tolerability, and efficacy of long-term treatment with esuberaprost sodium tablets (Beraprost Sodium 314d Modified Release tablets).

Timeline

Start
2018-12-10
Primary completion
2019-07-20
Completion
2019-07-20

Outcome

Outcome not reported

Stopped: “The pivotal study, BPS-314d-MR-PAH-302 (NCT01908699), failed to demonstrate efficacy.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Esuberaprost Small molecule 30 ug Oral