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:	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

Resource links provided by NLM:

MedlinePlus related topics: 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 ]

Estimated Enrollment:	72
Study Start Date:	December 2008
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (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
B: Experimental Active Comparator	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

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

Contacts

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.

Locations

United States, Florida
Jacksonville Center For Clinical Research - Univ Campus	Recruiting
Jacksonville, Florida, United States, 32216
Contact: Ramon Castello, Site 010
Local Institution	Not yet recruiting
Chiefland, Florida, United States, 32626
Contact: Site 019
United States, Kentucky
L-Marc Research Center	Recruiting
Louisville, Kentucky, United States, 40213
Contact: Harold E. Bays, Site 013 502-515-5672
Commonwealth Biomedical Research, Llc	Recruiting
Madisonville, Kentucky, United States, 42431
Contact: Bret A. Wittmer, Site 014 270-825-8345
United States, Massachusetts
Yawkey 5b, 5904	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Ahmed Tawakol, Site 001
United States, Michigan
William Beaumont Hospital	Recruiting
Royal Oak, Michigan, United States, 48073
Contact: C. Oliver Wong, Site 007 248-898-4132
Troy Internal Medince Pc/Research	Recruiting
Troy, Michigan, United States, 48098
Contact: Neil Fraser, Site 016
United States, Minnesota
University Of Minnesota - Cardiovascular Division	Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Daniel Duprez, Site 011 612-626-4566
United States, New York
Mount Sinai School Of Medicine Imaging Science Laboratories	Recruiting
New York, New York, United States, 10029
Contact: Zahi Adel Fayad, Site 002
United States, North Carolina
The Lipid Center	Recruiting
Statesville, North Carolina, United States, 28677
Contact: James M. Rhyne, Site 008
United States, Ohio
Metabolic And Atherosclerosis Research Center	Recruiting
Cincinnati, Ohio, United States, 45212
Contact: Evan A. Stein, Site 006
Local Institution	Not yet recruiting
Cincinnati, Ohio, United States, 45219
Contact: Site 018
United States, Pennsylvania
Local Institution	Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Site 012
United States, Texas
Baylor College Of Medicine	Recruiting
Houston, Texas, United States, 77030
Contact: Christie Ballantyne, Site 009
Local Institution	Not yet recruiting
Mc Allen, Texas, United States, 78503
Contact: Site 017

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

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	IM119-014
Study First Received:	December 10, 2007
Last Updated:	November 16, 2009
ClinicalTrials.gov Identifier:	NCT00570752 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Vascular Diseases
Enzyme Inhibitors

Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Atorvastatin

ClinicalTrials.gov processed this record on November 27, 2009