Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis - Full Text View

Sponsor:	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

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:

MedlinePlus related topics: Atherosclerosis Statins Vascular Diseases

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

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

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

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

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 February 12, 2012