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

2014-08-27 03:18:52 | BioPortfolio

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. 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.

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.

Study Design

Control: Active Control, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Pulmonary Arterial Hypertension

Intervention

Beraprost Sodium Modified Release

Location

Harbor-UCLA Medical Center
Torrance
California
United States
90502

Status

Recruiting

Source

Lung Rx

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:52-0400

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