Ignite Creation Date:
2024-05-05 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 9:57 AM
Study NCT ID:
NCT00792571
Status:
COMPLETED
Last Update Posted:
2019-12-26
First Post:
2008-11-14
Brief Title:
An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension PAH Patients
Sponsor:
Lung Biotechnology PBC
Organization:
Lung Biotechnology PBC
Study Overview
Official Title:
An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension PAH Patients
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 following enrollment in the study at 3 6 and 12 months and annually thereafter for assessment
Currently enrolled patients may be invited to participate in an optional four times daily QID dosing substudy of BPS-MR with total daily dose of BPS-MR achieved previously in the main study Patients will return to the clinic for baseline visit week 12 and then will follow the visit schedule provided to them in BPS-MR-PAH-202 main study
Currently enrolled patients may be invited to participate in an optional four times daily QID dosing substudy of BPS-MR with total daily dose of BPS-MR achieved previously in the main study Patients will return to the clinic for baseline visit week 12 and then will follow the visit schedule provided to them in BPS-MR-PAH-202 main study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None