Ignite Creation Date:
2024-05-05 @ 9:56 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00990314
Status:
COMPLETED
Last Update Posted:
2019-09-16
First Post:
2009-10-05
Brief Title:
Extension of BPS-MR-PAH-203 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-203 in Pulmonary Arterial Hypertension PAH Patients
Status:
COMPLETED
Status Verified Date:
2019-09
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 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
Detailed Description:
Eligible patients who participated in BPS-MR-PAH-203 and who elect to continue receiving study drug in an open-label extensionEach 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 bid per day and a minimum decrement of one tablet 60µg bid 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
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-204 main study
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 bid per day and a minimum decrement of one tablet 60µg bid 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
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-204 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