Extension of BPS-MR-PAH-203 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

NCT00990314

BPS-MR-PAH-204

Details and patient eligibility

About

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.

Full description

Eligible patients who participated in BPS-MR-PAH-203 and who elect to continue receiving study drug in an open-label extension.Each patient will return to the clinic following enrollment in the study at 3, 6, and 12 months, and annually thereafter for assessment. Patients will be called by study personnel to assess adverse events and concomitant medications at Month 9, and at 3 month intervals following the annual visit.

At the End of Study visit, patients discontinuing study drug will be down-titrated off of BPS-MR at the discretion of the Investigator, at a maximum decrement of one tablet (60µg) b.i.d. per day and a minimum decrement of one tablet (60µg) b.i.d. per week. Likewise, patients who withdraw early from the study will be down-titrated off of BPS-MR in the same manner. Upon completion of down-titration, patients will return to the clinic for a final Closeout visit.

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-204 main study.

Enrollment

31 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 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.