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| Descriptive Information Fields | |||||||||
| Brief Title † | Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis | ||||||||
| Official Title † | A 12-Week, Randomized, Semi Double-Blinded Study Evaluating the Effects of Daily Oral High-Dose Atorvastatin or BMS-582949 on Atherosclerotic Plaque Inflammation as Determined by FDG-PET in High Risk Atherosclerotic Patients | ||||||||
| Brief Summary | The purpose of the study is to determine whether a p38 kinase inhibitor reduces inflammation in atherosclerotic plaque |
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| Detailed Description | |||||||||
| Study Phase | Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | FDG-PET signal of the carotid and/or ascending aorta [ Time Frame: at 4 and 12 weeks ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Inflammatory and thrombotic biomarkers [ Time Frame: will be measured throughout the 12 weeks of treatment ] [ Designated as safety issue: No ] | ||||||||
| Condition † | Vascular Diseases | ||||||||
| Intervention † | Drug: Placebo + background low to moderate dose statin Drug: BMS-582949 + Background low to moderate dose statin Drug: Atorvastatin |
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| MEDLINE PMIDs | |||||||||
| Links | BMS Clinical Trials Disclosure  For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 72 | ||||||||
| Start Date † | November 2008 | ||||||||
| Completion Date | July 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00570752 | ||||||||
| Organization ID | IM119-014 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Bristol-Myers Squibb | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Bristol-Myers Squibb | ||||||||
| Verification Date | November 2008 | ||||||||
| First Received Date † | December 10, 2007 | ||||||||
| Last Updated Date | November 19, 2008 | ||||||||
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