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

Completed · Phase 2

Conditions studied: Pulmonary Arterial Hypertension

In brief

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.

Key facts

Study ID

NCT00990314

Run by

Lung Biotechnology PBC

People needed

31

Starts

2009-11-30

Expected to finish

2013-11-30

Last updated by the study team

2019-09-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Harbor-UCLA Medical Center — Torrance, California, United States
• Midwest Heart Foundation - Advocate Medical Group — Oakbrook Terrace, Illinois, United States
• Beth Israel Medical Center — New York, New York, United States
• Albert Einstein College of Medicine — The Bronx, New York, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• Universite Libre de Bruxelles — Brussels, Belgium
• Catholic University of Leuven — Leuven, Belgium
• General Teaching Hospital — Prague, Czechia
• Klinikum der Universitat zu Koln — Cologne, Germany
• Medizinische Klinik und Poliklinik — Dresden, Germany
• Abt Innere Medizin III, Medizinische Universitatsklinik — Heidelberg, Germany
• Universitatsklinik Leipzig Abteilung Pulmologie — Leipzig, Germany
• Mater Misericordiae University Hospital Ltd. — Dublin, Ireland
• Institutul de Urgenta pentru Boli — Bucharest, Romania
• Institutul National de Pneumologie — Bucharest, Romania
• Institutul de Boli Cardiovasculare — Lasi, Romania

Full record on ClinicalTrials.gov

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