Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Atorvastatin; Atorvastatin Calcium; Hydroxymethylglutaryl-CoA Reductase Inhibitors

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