Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis

Status:	Completed
Conditions:	Peripheral Vascular Disease, Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - 75
Updated:	4/21/2016
Start Date:	December 2008
End Date:	December 2010

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

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

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

We found this trial at

sites

Hospital of the University of Pennsylvania

3400 Spruce St
Philadelphia, Pennsylvania 19104

(215) 662-4000