Overview

Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) Patients

Status:
Completed
Trial end date:
2013-11-30
Target enrollment:
0
Participant gender:
All
Summary
This is an open-label study for patients who participated in the BPS-MR-PAH-203 study and have volunteered to continue treatment for PAH with Beraprost Sodium Modified Release (BPS-MR) tablets.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Lung Biotechnology PBC
Treatments:
Beraprost
Epoprostenol
Criteria
Inclusion Criteria:

- Patients who remained on study drug and completed all assessments during the Treatment
Phase of Study BPS MR PAH 203 are eligible for this study.

- Women of child-bearing potential (defined as less than 1 year post-menopausal or not
surgically sterile) must be using an acceptable method of birth control or practicing
abstinence. If sexually active, female patients must use a double barrier method of
birth control, such as a condom and spermicidal.

Exclusion Criteria:

- Patients who discontinued study drug during the previous study (BPS MR PAH 203) for
any reason (e.g. treatment related adverse events) are not eligible for entry into
this study.

- Patients who are pregnant or lactating are excluded from participation in the
open-label extension.