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

Status:	Archived
Conditions:	High Blood Pressure (Hypertension)
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	November 2009
End Date:	January 2012

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

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. Patients will begin the study at the final, twice daily (b.i.d.) dose
achieved during their participation in the BPS-MR-PAH-203 study.

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 (60Âµg)
b.i.d. per day and a minimum decrement of one tablet (60Âµg) 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.

We found this trial at

sites

Allegheny Endocrinology Associates

Pittsburgh, Pennsylvania 15212

from

Pittsburgh, PA