Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00570752
First received: December 10, 2007
Last updated: March 23, 2011
Last verified: January 2011
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- FDG-PET signal of the carotid and/or ascending aorta [ Time Frame: at 4 and 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Inflammatory and thrombotic biomarkers [ Time Frame: will be measured throughout the 12 weeks of treatment ] [ Designated as safety issue: No ]
| Enrollment: | 72 |
| Study Start Date: | December 2008 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Placebo
|
Drug: Placebo + background low to moderate dose statin
Tablets, Oral, 0 mg, once daily, for 12 weeks
|
|
Experimental: B
Active Comparator
|
Drug: BMS-582949 + Background low to moderate dose statin
Tablets, Oral, 100 mg, once daily for 12 weeks
|
| Active Comparator: C |
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 |
Criteria
Inclusion Criteria:
- History of documented atherosclerosis
- LDL between 70 and 130 mg/dL
- Patients receiving stable low- to moderate-dose statin
- BMI 18-37 kg/m²
- Must be able to swallow tablets
- Must be able to medically tolerate the procedures, contrast medium, and medications involved
Exclusion Criteria:
- Statin intolerance
- Renal impairment (serum creatinine > 1.5 mg/dL)
- History of chronic viral hepatitis or other liver dysfunction
- Major infection requiring hospitalization or receipt of IV antibiotics due to an infection within 2 months prior to initiation of study treatment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570752
Locations
| United States, Florida | |
| Southeast Clinical Research, Llc | |
| Chiefland, Florida, United States, 32626 | |
| Jacksonville Center For Clinical Research - Univ Campus | |
| Jacksonville, Florida, United States, 32216 | |
| Florida Cardiovascular Institute | |
| Tampa, Florida, United States, 33609 | |
| United States, Indiana | |
| Phillip D. Toth, Md | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Kentucky | |
| L-Marc Research Center | |
| Louisville, Kentucky, United States, 40213 | |
| Commonwealth Biomedical Research, Llc | |
| Madisonville, Kentucky, United States, 42431 | |
| United States, Massachusetts | |
| Mgh Cardiac Mr Pet Ct Program | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| Troy Internal Medince Pc/Research | |
| Troy, Michigan, United States, 48098 | |
| United States, Minnesota | |
| Radiant Research, Inc. | |
| Edina, Minnesota, United States, 55435 | |
| United States, New York | |
| Mount Sinai School Of Medicine Imaging Science Laboratories | |
| New York, New York, United States, 10029 | |
| United States, North Carolina | |
| The Lipid Center | |
| Statesville, North Carolina, United States, 28677 | |
| United States, Ohio | |
| Metabolic And Atherosclerosis Research Center | |
| Cincinnati, Ohio, United States, 45212 | |
| Sterling Research Group | |
| Cincinnati, Ohio, United States, 45219 | |
| United States, Pennsylvania | |
| Hospital Of The University Of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| Radiant Research, Inc. | |
| Dallas, Texas, United States, 75231 | |
| Baylor College Of Medicine | |
| Houston, Texas, United States, 77030 | |
| Mcallen Heart Clinic | |
| Mc Allen, Texas, United States, 78503 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00570752 History of Changes |
| Other Study ID Numbers: | IM119-014 |
| Study First Received: | December 10, 2007 |
| Last Updated: | March 23, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Vascular Diseases Cardiovascular Diseases Atorvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013