An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients

Lung Biotechnology

Status and phase

Completed

Phase 2

Conditions

Pulmonary Arterial Hypertension

Treatments

Drug: Beraprost Sodium Modified Release

Study type

Interventional

Funder types

Industry

Identifiers

NCT00792571

BPS-MR-PAH-202

Details and patient eligibility

About

This is an open-label extension study for patients who participated in the BPS-MR-PAH-201 study.

Full description

This is an open-label study for patients who participated in the BPS-MR-PAH-201 study and have volunteered to continue treatment for PAH with BPS-MR tablets. Each patient will return to the clinic following enrollment in the study at 3, 6, and 12 months, and annually thereafter for assessment.

Currently enrolled patients may be invited to participate in an optional four times daily (QID) dosing substudy of BPS-MR with total daily dose of BPS-MR achieved previously in the main study. Patients will return to the clinic for baseline visit, week 12, and then will follow the visit schedule provided to them in BPS-MR-PAH-202 main study.

Enrollment

18 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients who remained on study drug and completed all assessments during the Treatment Phase of Study BPS-MR-PAH-201 are eligible for this study.
Female patients must either be physiologically incapable of childbearing or be practicing an acceptable method of birth control (e.g. approved hormonal contraceptive, barrier method, such as condom or diaphragm, used with a spermicide, or an intrauterine device).

Exclusion criteria

Patients who discontinued study drug during the previous study (BPS-MR-PAH-201) 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.