Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Vascular Diseases

In brief

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

Key facts

Study ID

NCT00570752

Run by

Bristol-Myers Squibb

People needed

72

Starts

2008-12-01

Expected to finish

2010-12-01

Last updated by the study team

2015-12-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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