An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients

Completed · Phase 2

Conditions studied: Pulmonary Arterial Hypertension

In brief

This is an open-label extension study for patients who participated in the BPS-MR-PAH-201 study.

Key facts

Study ID

NCT00792571

Run by

Lung Biotechnology PBC

People needed

18

Starts

2009-02-28

Expected to finish

2013-11-30

Last updated by the study team

2019-12-26

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-201 are eligible for this study.
• Female patients must either be physiologically incapable of childbearing or be practicing an acceptable method of birth control (e.g. approved hormonal contraceptive, barrier method, such as condom or diaphragm, used with a spermicide, or an intrauterine device).

You may not qualify if…

• Patients who discontinued study drug during the previous study (BPS-MR-PAH-201) 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
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• UTSW Medical Center Dallas — Dallas, Texas, United States
• Universite Libre de Bruxelles — Brussels, Belgium
• Gastuisberg University Hospital — Leuven, Belgium
• Mater Misericordiae University Hospital Ltd. — Dublin, Ireland

Full record on ClinicalTrials.gov

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