Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208299
Status:
COMPLETED
Last Update Posted:
2009-11-26
First Post:
2005-09-13
Brief Title:
ADVANCE MPI 1 Study of Regadenoson Versus Adenoscan in Patients Undergoing Myocardial Perfusion Imaging MPI
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
A Phase III Randomized Double-Blind Study of Intravenous CVT-3146 Versus Adenoscan in Patients Undergoing Stress Myocardial Perfusion Imaging
Status:
COMPLETED
Status Verified Date:
2009-11
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:
Adenoscan adenosine is an approved pharmacological stress agent indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately The investigational drug regadenoson CVT-3146 is a selective A2A adenosine receptor agonist the receptor responsible for coronary vasodilation and is being studied for potential use as a pharmacologic stress agent in myocardial perfusion imaging MPI studies This study will compare the safety and efficacy of regadenoson to that of Adenoscan in detecting reversible myocardial perfusion defects
Detailed Description:
ADVANCE MPI 1 is a multi-national double-blind randomized active-controlled parallel group clinical trial to evaluate the safety and efficacy of regadenoson in SPECT MPI compared to that of the approved pharmacological stress agent Adenoscan Patients referred for a clinically indicated pharmacological stress MPI study will be eligible for enrollment The trial is designed
to compare the pharmacological stress SPECT images obtained with regadenoson to those obtained with Adenoscan and
to compare the safety and tolerability of the two stress agents
to compare the pharmacological stress SPECT images obtained with regadenoson to those obtained with Adenoscan and
to compare the safety and tolerability of the two stress agents
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