Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055510
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2003-03-04
Brief Title:
A Blinded Study Conducted at Multiple Centers Evaluating Various Doses of an Investigational Agent BO-653 Against Placebo for Safety and Effectiveness in Preventing Post-Angioplasty Blood Vessel Re-Closure Restenosis in Stented Vessels
Sponsor:
Chugai Pharma USA
Organization:
Chugai Pharma USA
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2004-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study is intended to evaluate the safety and effectiveness of 3 different doses of BO-653 an investigational inhibitor of LDL cholesterol oxidation when given orally twice a day compared to placebo an inactive substance in preventing restenosis closure of vessel within six months after stent implantation Patients must be enrolled into this study within 24 hours after the stenting procedure
Additionally over a 1- to 9-month post-stent period the study will compare the safety and effectiveness of BO-653 versus placebo for measures of coronary artery vessel size by quantitative coronary angiography major adverse cardiac events and effects on the oxidative status of plasma lipids and other plasma components
Additionally over a 1- to 9-month post-stent period the study will compare the safety and effectiveness of BO-653 versus placebo for measures of coronary artery vessel size by quantitative coronary angiography major adverse cardiac events and effects on the oxidative status of plasma lipids and other plasma components
Detailed Description:
None
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