Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00320502
Status:
COMPLETED
Last Update Posted:
2008-08-25
First Post:
2006-04-30
Brief Title:
A Phase 2 Study to Determine the Effects of BXT-51072 in Diabetic Patients Undergoing Angioplasty PCI
Sponsor:
Synvista Therapeutics Inc
Organization:
Synvista Therapeutics Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Parallel Group Study to Determine the Effects of BXT-51072 on CK-MB in High-Risk Type 2 Diabetic Patients Undergoing Elective Percutaneous Coronary Intervention
Status:
COMPLETED
Status Verified Date:
2008-08
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:
The purpose of this study is to determine the safety and feasibility of BXT-51072 as a cardioprotective agent in diabetics undergoing elective angioplasty percutaneous intervention PCI a procedure to open coronary arteries
BXT-51072 belongs to a class of drugs called glutathione peroxidase mimics BXT-51072 works by imitating a substance produced in various tissues in the body which prevents damage of the heart and blood vessels
BXT-51072 belongs to a class of drugs called glutathione peroxidase mimics BXT-51072 works by imitating a substance produced in various tissues in the body which prevents damage of the heart and blood vessels
Detailed Description:
Following screening baseline measurements and informed consent patients will receive BXT-51072 40 mg or placebo in a 21 ratio 30 minutes before their scheduled PCI and then three times per day for 2 days There will be 5 treatment visits and 3 follow-up visits
Blood samples will be obtained for CK-MB troponin and routine chemistry A 24-hour continuous electrocardiogram will be obtained following the PCI and regular electrocardiograms will be obtained during the study and follow-up period
Blood samples will be obtained for CK-MB troponin and routine chemistry A 24-hour continuous electrocardiogram will be obtained following the PCI and regular electrocardiograms will be obtained during the study and follow-up period
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