Ignite Creation Date:
2024-05-05 @ 11:58 PM
Last Modification Date:
2024-10-26 @ 10:42 AM
Study NCT ID:
NCT01458236
Status:
WITHDRAWN
Last Update Posted:
2012-05-14
First Post:
2011-09-29
Brief Title:
A Multinational Multicenter Study to Assess the Efficacy and Safety of BPS-314d-MR in Subjects With Pulmonary Arterial Hypertension Currently Receiving Treatment With an Endothelin Receptor Antagonist andor a Phosphodiesterase-5 Inhibitor
Sponsor:
Lung Biotechnology PBC
Organization:
Lung Biotechnology PBC
Study Overview
Official Title:
A Multinational Multicenter Double-blind Randomized Placebo-controlled Phase III Study to Assess the Efficacy and Safety of BPS-314d-MR in Subjects With Pulmonary Arterial Hypertension Currently Receiving Treatment With an Endothelin Receptor Antagonist andor a Phosphodiesterase-5 Inhibitor
Status:
WITHDRAWN
Status Verified Date:
2012-05
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:
A multinational multicenter double-blind randomized placebo-controlled Phase III study to assess the efficacy and safety of BPS 314d-MR in subjects with pulmonary arterial hypertension currently receiving treatment with an Endothelin Receptor Antagonist ERA andor a Phosphodiesterase-5 Inhibitor PDE-5 inhibitor
Approximately 100 centers will be participating in the study Approximately 630 eligible subjects will be randomized 11 into two groups BPS-314d-MR active or placebo study drug
Approximately 100 centers will be participating in the study Approximately 630 eligible subjects will be randomized 11 into two groups BPS-314d-MR active or placebo study drug
Detailed Description:
This study is designed to evaluate the efficacy and safety of BPS-314d-MR in subjects with PAH who are treated with background therapy such as ERA andor a PDE-5 inhibitor
Subjects who consent to the study will be assessed at the Screening and Baseline visits to determine eligibility for the study Subjects meeting eligibility criteria at the Baseline visit will be enrolled into the study and treated by either active or placebo study drug The subject the clinical site staff and the Sponsor will be blinded to the treatment assignment Treatment assignment will be random
Following the Baseline visit subjects will return to the clinical site at Week 6 Week 12 Week 20 and every 12 weeks thereafter Subjects will undergo all scheduled efficacy and safety assessments as defined by the protocol Between scheduled clinical site visits the clinical site staff will be required to contact the subject by a telephone call to assess tolerability to study drug and change subjects dosage as appropriate Telephone calls should occur at least once weekly for the first 20 study weeks when dose changes will occur most frequently and subjects are becoming familiar with the study procedures Telephone calls will occur at least once monthly thereafter Subjects will be provided with an electronic diary to record doses taken and help in tracking of health issues for conversations with the clinical site staff
Subjects will continue their participation in the study until the Sponsor formally closes the study At that time the subject will return to the clinical site for an End of Treatment visit to complete all scheduled tests Subjects who are participating in the study at its conclusion may be offered the opportunity to enroll in a long-term extension study Subjects who do not continue into an extension study are required to discontinue from study drug
Subjects will be urged to remain in the study for long-term follow-up even if study drug is discontinued
In the event that a subject withdraws consent for participation in the study or the Investigator terminates the subject from the study the subject will return to the clinical site for an End of Treatment visit to complete all scheduled tests After study drug has been permanently discontinued and if the subject is terminated from the study the subject will return to the clinical site after 30-37 days for a final Safety Follow-up visit and to return any remaining study drug
The optional Pharmacokinetic PK evaluation will be offered to all study subjects at clinical sites Subjects within those sites will decide if they wish to participate in the optional PK evaluation For those subjects electing to participate two blood samples will be collected at three clinical site visits Weeks 6 12 and 20
The optional hemodynamic sub-study will be offered to all study subjects at clinical sites All subjects at the selected research centers will be offered the opportunity to volunteer in the sub-study Hemodynamic measurements will be assessed by Right Heart Catheterization RHC For those subjects who consent to the RHC the RHC procedure will be performed at the Baseline visit and during Week 20
Subjects who consent to the study will be assessed at the Screening and Baseline visits to determine eligibility for the study Subjects meeting eligibility criteria at the Baseline visit will be enrolled into the study and treated by either active or placebo study drug The subject the clinical site staff and the Sponsor will be blinded to the treatment assignment Treatment assignment will be random
Following the Baseline visit subjects will return to the clinical site at Week 6 Week 12 Week 20 and every 12 weeks thereafter Subjects will undergo all scheduled efficacy and safety assessments as defined by the protocol Between scheduled clinical site visits the clinical site staff will be required to contact the subject by a telephone call to assess tolerability to study drug and change subjects dosage as appropriate Telephone calls should occur at least once weekly for the first 20 study weeks when dose changes will occur most frequently and subjects are becoming familiar with the study procedures Telephone calls will occur at least once monthly thereafter Subjects will be provided with an electronic diary to record doses taken and help in tracking of health issues for conversations with the clinical site staff
Subjects will continue their participation in the study until the Sponsor formally closes the study At that time the subject will return to the clinical site for an End of Treatment visit to complete all scheduled tests Subjects who are participating in the study at its conclusion may be offered the opportunity to enroll in a long-term extension study Subjects who do not continue into an extension study are required to discontinue from study drug
Subjects will be urged to remain in the study for long-term follow-up even if study drug is discontinued
In the event that a subject withdraws consent for participation in the study or the Investigator terminates the subject from the study the subject will return to the clinical site for an End of Treatment visit to complete all scheduled tests After study drug has been permanently discontinued and if the subject is terminated from the study the subject will return to the clinical site after 30-37 days for a final Safety Follow-up visit and to return any remaining study drug
The optional Pharmacokinetic PK evaluation will be offered to all study subjects at clinical sites Subjects within those sites will decide if they wish to participate in the optional PK evaluation For those subjects electing to participate two blood samples will be collected at three clinical site visits Weeks 6 12 and 20
The optional hemodynamic sub-study will be offered to all study subjects at clinical sites All subjects at the selected research centers will be offered the opportunity to volunteer in the sub-study Hemodynamic measurements will be assessed by Right Heart Catheterization RHC For those subjects who consent to the RHC the RHC procedure will be performed at the Baseline visit and during Week 20
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