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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
Hide Study Locations| United States, Arizona | |
| St. Luke's Medical Center | |
| Phoenix, Arizona, United States, 85006 | |
| University of Arizona Sarver Heart Center | |
| Tucson, Arizona, United States, 85724 | |
| United States, California | |
| Veterans Affairs Medical Center | |
| San Diego, California, United States, 92161 | |
| Clinical Research Center of California | |
| San Diego, California, United States, 92117 | |
| Cardiovascular Associates of the Peninsula | |
| Burlingame, California, United States, 94010 | |
| La Mesa Cardiac Center | |
| La Mesa, California, United States, 91942 | |
| Foundation for Cardiovascular Medicine | |
| La Jolla, California, United States, 92037 | |
| United States, Florida | |
| University of Florida Health Science Center | |
| Jacksonville, Florida, United States, 32209 | |
| Miami International Cardiology Consultants | |
| Miami Beach, Florida, United States, 33140 | |
| Mediquest Research Group | |
| Ocala, Florida, United States, 34474 | |
| United States, Illinois | |
| Midwest Heart Research Foundation | |
| Lombard, Illinois, United States, 60148 | |
| United States, Iowa | |
| Iowa Heart Center | |
| Des Moines, Iowa, United States, 50314 | |
| United States, Louisiana | |
| Alton Ochsner Medical Foundation | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| Baystate Medical Center | |
| Springfield, Massachusetts, United States, 01199 | |
| United States, Michigan | |
| Borgess Medical Center | |
| Kalamazoo, Michigan, United States, 49048 | |
| Michigan Heart | |
| Ypsilanti, Michigan, United States, 48197 | |
| United States, Minnesota | |
| Minneapolis Heart Institute Foundation | |
| Minneapolis, Minnesota, United States, 55407 | |
| United States, Missouri | |
| St. Louis University | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nevada | |
| Nevada Cardiology Associates | |
| Las Vegas, Nevada, United States, 89109 | |
| United States, New York | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| Asheville Cardiology Associates, PA | |
| Asheville, North Carolina, United States, 28803 | |
| United States, Ohio | |
| Northwestern Memorial Hospital | |
| Elyria, Ohio, United States, 44035 | |
| United States, Oklahoma | |
| Oklahoma Foundation for Cardiovascular Research | |
| Oklahoma City, Oklahoma, United States, 73120 | |
| United States, Texas | |
| University of Texas Health Science Center | |
| San Antonio, Texas, United States, 78229-3900 | |
| IRCI Institute for Research in Cardiovascular Interventions at The Methodist DeBakey Heart Center | |
| Houston, Texas, United States, 77030 | |
| Austin Heart | |
| Austin, Texas, United States, 78756 | |
| United States, Utah | |
| University of Utah | |
| Salt Lake City, Utah, United States, 84132 | |
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 |