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| Sponsor: | Chugai Pharma USA |
|---|---|
| Information provided by: | Chugai Pharma USA |
| ClinicalTrials.gov Identifier: | NCT00055510 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Graft Occlusion, Vascular Coronary Restenosis Atherosclerosis |
Drug: BO-653 |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Major Inclusion Criteria – Others Stipulated within the Protocol
The study physician must assure you:
Major Exclusion Criteria – Others Stipulated within the Protocol
The study physician must assure you:
Contacts and Locations
Show 29 Study Locations
More Information
| Study ID Numbers: | BO-004 |
| Study First Received: | March 4, 2003 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00055510 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
BO-653 Coronary restenosis Stent restenosis LDL oxidative inhibitor Antioxidant |
|
Atherosclerosis Arterial Occlusive Diseases Heart Diseases Myocardial Ischemia Vascular Diseases Arteriosclerosis Coronary Restenosis |
Coronary Stenosis Coronary Disease Graft Occlusion, Vascular Pathologic Processes Postoperative Complications Cardiovascular Diseases |