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

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

U.S. FDA Resources

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

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:	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
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

Criteria

Inclusion Criteria:

History of documented atherosclerosis
LDL between 70 and 200 mg/dL
Patients receiving stable low- to moderate-dose statin
BMI 18-35 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, 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

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

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

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