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| Sponsored by: |
Bristol-Myers Squibb |
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00570752 |
Purpose
The purpose of the study is to determine whether a p38 kinase inhibitor reduces inflammation in atherosclerotic plaque
| Condition | Intervention | Phase |
|
Vascular Diseases |
Drug: Placebo + background low to moderate dose statin Drug: BMS-582949 + Background low to moderate dose statin Drug: Atorvastatin |
Phase II |
| MedlinePlus related topics: | Vascular Diseases |
| ChemIDplus related topics: | Atorvastatin Atorvastatin calcium |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 130 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | April 2009 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
A: Active Comparator
Placebo
|
Drug: Placebo + background low to moderate dose statin
Tablets, Oral, 0 mg, once daily, for 12 weeks
|
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B: Experimental
Active Comparator
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Drug: BMS-582949 + Background low to moderate dose statin
Tablets, Oral, 100 mg, once daily for 12 weeks
|
| C: Active Comparator |
Drug: Atorvastatin
Tablets, oral, 80 mg once daily for 12 weeks
|
Eligibility
| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: | Clinical.Trials@bms.com | |
| Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time. |
| United States, Maine | |||||
| Local Institution | Not yet recruiting | ||||
| Scarborough, Maine, United States, 04074 | |||||
| Contact: Site 003 | |||||
| United States, Massachusetts | |||||
| Local Institution | Not yet recruiting | ||||
| Boston, Massachusetts, United States, 02114 | |||||
| Contact: Site 001 | |||||
| Local Institution | Not yet recruiting | ||||
| Worchester, Massachusetts, United States, 01605 | |||||
| Contact: Site 005 | |||||
| United States, New York | |||||
| Local Institution | Not yet recruiting | ||||
| New York, New York, United States, 10029 | |||||
| Contact: Site 002 | |||||
| United States, Ohio | |||||
| Local Institution | Not yet recruiting | ||||
| Cincinnati, Ohio, United States, 45212 | |||||
| Contact: Site 006 | |||||
| Bristol-Myers Squibb |
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
BMS Clinical Trials Disclosure 
  |
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm 
  |
| Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
| Study ID Numbers: | IM119-014 |
| First Received: | December 10, 2007 |
| Last Updated: | August 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00570752 |
| Health Authority: | United States: Food and Drug Administration |
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