Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00570752
Recruitment Status : Completed
First Posted : December 11, 2007
Last Update Posted : December 7, 2015
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of the study is to determine whether a p38 kinase inhibitor reduces inflammation in atherosclerotic plaque

Condition or disease Intervention/treatment Phase
Vascular Diseases Other: Placebo Drug: BMS-582949 Drug: Atorvastatin Drug: Statin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Placebo + background low to moderate dose statin
Placebo + background low to moderate dose statin Tablets, Oral, 0 mg, once daily, for 12 weeks
Other: Placebo
Drug: Statin
Experimental: BMS-582949 + Background low to moderate dose statin
BMS-582949 + Background low to moderate dose statin Tablets, Oral, 100 mg, once daily for 12 weeks
Drug: BMS-582949
Drug: Statin
Active Comparator: Atorvastatin
Atorvastatin Tablets, oral, 80 mg once daily for 12 weeks
Drug: Atorvastatin

Primary Outcome Measures :
  1. FDG-PET signal of the carotid and/or ascending aorta [ Time Frame: at 4 and 12 weeks ]

Secondary Outcome Measures :
  1. Inflammatory and thrombotic biomarkers [ Time Frame: will be measured throughout the 12 weeks of treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00570752

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
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb Identifier: NCT00570752     History of Changes
Other Study ID Numbers: IM119-014
First Posted: December 11, 2007    Key Record Dates
Last Update Posted: December 7, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Atorvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors