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

Tracking Information

First Received Date ^ICMJE

December 10, 2007

Last Updated Date

November 4, 2009

Start Date ^ICMJE

December 2008

Estimated Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

FDG-PET signal of the carotid and/or ascending aorta [ Time Frame: at 4 and 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00570752 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Inflammatory and thrombotic biomarkers [ Time Frame: will be measured throughout the 12 weeks of treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Inflammatory and thrombotic biomarkers [ Time Frame: will be measured throughout the 12 weeks of treatment ]

Descriptive Information

Brief Title ^ICMJE

Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Vascular Diseases

Intervention ^ICMJE

Drug: Placebo + background low to moderate dose statin
Drug: BMS-582949 + Background low to moderate dose statin
Drug: Atorvastatin

Study Arms / Comparison Groups

Active Comparator: Placebo
Experimental: Active Comparator

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2010

Estimated Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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.

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00570752

Responsible Party

Study Director, Bristol-Myers Squibb

Study ID Numbers ^ICMJE

IM119-014

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP