Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis

Vascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00570752
• Other study ID #: IM119-014
• Status: Completed
• Phase: Phase 2
• First received: December 10, 2007
• Last updated: November 6, 2015
• Start date: December 2008
• Est. completion date: December 2010

Study information

• Verified date: November 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vascular Diseases

Intervention

Other:
• Placebo

Drug:
• BMS-582949

• Atorvastatin

• Statin

Locations

Country	Name	City	State
United States	Mgh Cardiac Mr Pet Ct Program	Boston	Massachusetts
United States	Southeast Clinical Research, Llc	Chiefland	Florida
United States	Metabolic And Atherosclerosis Research Center	Cincinnati	Ohio
United States	Sterling Research Group	Cincinnati	Ohio
United States	Radiant Research, Inc.	Dallas	Texas
United States	Radiant Research, Inc.	Edina	Minnesota
United States	Baylor College Of Medicine	Houston	Texas
United States	Phillip D. Toth, Md	Indianapolis	Indiana
United States	Jacksonville Center For Clinical Research - Univ Campus	Jacksonville	Florida
United States	L-Marc Research Center	Louisville	Kentucky
United States	Commonwealth Biomedical Research, Llc	Madisonville	Kentucky
United States	Mcallen Heart Clinic	Mc Allen	Texas
United States	Mount Sinai School Of Medicine Imaging Science Laboratories	New York	New York
United States	Hospital Of The University Of Pennsylvania	Philadelphia	Pennsylvania
United States	The Lipid Center	Statesville	North Carolina
United States	Florida Cardiovascular Institute	Tampa	Florida
United States	Troy Internal Medince Pc/Research	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FDG-PET signal of the carotid and/or ascending aorta		at 4 and 12 weeks	No
Secondary	Inflammatory and thrombotic biomarkers		will be measured throughout the 12 weeks of treatment	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form