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

NCT03657095 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2020-09-07

Study results available
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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).

Conditions

Interventions

DRUG

Esuberaprost

Sodium tablets

DRUG

Placebo

Placebo tablets, which are identical in size and appearance to those containing Esuberaprost.

Sponsors & Collaborators

  • Lung Biotechnology PBC

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-10
Primary Completion
2019-07-20
Completion
2019-07-20
FDA Drug
Yes

Countries

  • United States
  • Israel

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03657095 on ClinicalTrials.gov