Ignite Creation Date:
2024-05-05 @ 9:52 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00989963
Status:
COMPLETED
Last Update Posted:
2020-09-30
First Post:
2009-10-05
Brief Title:
Dose-response Study of the Safety and Efficacy of Beraprost Sodium Modified Release BPS-MR in Patients With Pulmonary Arterial Hypertension PAH
Sponsor:
Lung Biotechnology PBC
Organization:
Lung Biotechnology PBC
Study Overview
Official Title:
A 12-week Double-blind International Multicenter Dose-response Study of the Safety and Efficacy of Beraprost Sodium Modified Release BPS-MR in Patients With Pulmonary Arterial Hypertension PAH
Status:
COMPLETED
Status Verified Date:
2020-09
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 a 12-week international multicenter double-blind three-group dose-response study to assess the safety and efficacy of BPS-MR in patients with PAH Eligible patients will have been previously diagnosed with PAH and will be on a stable course of an ERA andor PDE-5 inhibitor for at least 60 days prior to Baseline
Patients will be randomized to 1 of 3 treatment groups in a 111 ratio and will be stratified by PAH background therapy Endothelium Receptor Antagonist ERA Phosphodiesterase-5 PDE-5 and both The treatment groups consist of one Maximum Tolerated Dose MTD and two Fixed Dose FD groups Following randomization patients will begin taking active drug 60µg orally twice daily Patients will visit their investigational site at Week 6 and Week 12 for study evaluations
Patients will be randomized to 1 of 3 treatment groups in a 111 ratio and will be stratified by PAH background therapy Endothelium Receptor Antagonist ERA Phosphodiesterase-5 PDE-5 and both The treatment groups consist of one Maximum Tolerated Dose MTD and two Fixed Dose FD groups Following randomization patients will begin taking active drug 60µg orally twice daily Patients will visit their investigational site at Week 6 and Week 12 for study evaluations
Detailed Description:
This is a 12-week international multicenter double-blind three-group dose-response study to assess the safety and efficacy of BPS-MR in patients with PAH Eligible patients will have been previously diagnosed with PAH and will be on a stable course of an ERA andor PDE-5 inhibitor for at least 60 days prior to Baseline
A total of approximately 36 patients will be randomized to 1 of 3 treatment groups 12 per group in a 111 ratio and will be stratified by PAH background therapy ERA PDE-5 and both The treatment groups consist of one MTD and two FD groups Following randomization patients will begin taking active drug 60µg orally twice daily Patients will visit their investigational site at Week 6 and Week 12 for study evaluations Between visits clinical site personnel will contact patients by phone each week to assess tolerability provide instructions for a change in dosage record changes in concomitant medications and record adverse events Patients who complete the study will be offered the opportunity to continue taking study medication in a separate open-label continuation protocol Patients who withdraw early from the study or who otherwise do not elect to enroll into the open-label continuation protocol will be down-titrated off of BPS-MR at the discretion of the Investigator at a maximum decrement not to exceed one tablet 60µg bid per day and a minimum decrement of one tablet 60µg bid per week
Patients in the iMTD treatment group will dose escalate weekly by 60µg bid until they reach the maximum dose of 600µg bid or they reach an intolerable dose which requires them to down-titrate by 60µg bid In these instances and at the Investigators discretion further attempts at dose escalation may be made
The FD treatment groups will consist of a low dose group receiving 60µg bid and a high dose group receiving 240µg bid Patients in the high dose group will dose escalate weekly by 60µg bid until they reach the fixed dose of 240µg bid Once patients in these treatment groups have reached their assigned maximum dose of active drug weekly increases in the number of placebo tablets administered will continue in order to maintain the blind
Patients will be requested to maintain a daily diary of symptoms and study drug administration for evaluation by clinical site personnel Also patients will be given the option to contribute blood for pharmacokinetic assessment of BPSBPS-314d plasma concentrations at the Week 12 visit
A total of approximately 36 patients will be randomized to 1 of 3 treatment groups 12 per group in a 111 ratio and will be stratified by PAH background therapy ERA PDE-5 and both The treatment groups consist of one MTD and two FD groups Following randomization patients will begin taking active drug 60µg orally twice daily Patients will visit their investigational site at Week 6 and Week 12 for study evaluations Between visits clinical site personnel will contact patients by phone each week to assess tolerability provide instructions for a change in dosage record changes in concomitant medications and record adverse events Patients who complete the study will be offered the opportunity to continue taking study medication in a separate open-label continuation protocol Patients who withdraw early from the study or who otherwise do not elect to enroll into the open-label continuation protocol will be down-titrated off of BPS-MR at the discretion of the Investigator at a maximum decrement not to exceed one tablet 60µg bid per day and a minimum decrement of one tablet 60µg bid per week
Patients in the iMTD treatment group will dose escalate weekly by 60µg bid until they reach the maximum dose of 600µg bid or they reach an intolerable dose which requires them to down-titrate by 60µg bid In these instances and at the Investigators discretion further attempts at dose escalation may be made
The FD treatment groups will consist of a low dose group receiving 60µg bid and a high dose group receiving 240µg bid Patients in the high dose group will dose escalate weekly by 60µg bid until they reach the fixed dose of 240µg bid Once patients in these treatment groups have reached their assigned maximum dose of active drug weekly increases in the number of placebo tablets administered will continue in order to maintain the blind
Patients will be requested to maintain a daily diary of symptoms and study drug administration for evaluation by clinical site personnel Also patients will be given the option to contribute blood for pharmacokinetic assessment of BPSBPS-314d plasma concentrations at the Week 12 visit
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