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.