Status:
COMPLETED
An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients
Lead Sponsor:
Lung Biotechnology PBC
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is an open-label extension study for patients who participated in the BPS-MR-PAH-201 study.
Detailed Description
This is an open-label study for patients who participated in the BPS-MR-PAH-201 study and have volunteered to continue treatment for PAH with BPS-MR tablets. Each patient will return to the clinic fol...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
February 28 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00792571
Start Date
February 28 2009
End Date
November 30 2013
Last Update
December 26 2019
Active Locations (6)
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1
Harbor-UCLA Medical Center
Torrance, California, United States, 90502
2
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
3
UTSW Medical Center Dallas
Dallas, Texas, United States, 75390-8550
4
Universite Libre de Bruxelles
Brussels, Belgium