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

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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 (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.


We found this trial at
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Pittsburgh, Pennsylvania 15212
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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5303 Harry Hines Boulevard
Dallas, Texas 75390
(214) 648-3111
UT Soutwestern Medical Center at Dallas UT Southwestern Medical Center is distinctive for its overall...
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1300 Morris Park Ave
Bronx, New York 10461
(718) 430-2000
Albert Einstein College of Medicine The Albert Einstein College of Medicine of Yeshiva University is...
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Bronx, NY
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Torrance, California 90509
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Torrance, CA
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