drugset / Trial / NCT03657095
A Study With BPS-314d-MR-PAH-303 in Participants With Pulmonary Arterial Hypertension
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Esuberaprost | Small molecule | 30 ug | Oral |