Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis

Phase 2

Completed

• Conditions: Vascular Diseases
• Interventions: Drug: Atorvastatin; Other: Placebo; Drug: BMS-582949; Drug: Statin

• Registration Number: NCT00570752
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-12-10
• Study First Submitted QC: 2007-12-10
• Study First Posted: 2007-12-11
• Study Start: 2008-12
• Primary Completion: 2010-11
• Study Completion: 2010-12
• Disposition First Submitted: 2012-03-24
• Disposition First Submitted QC: 2015-09-23
• Disposition First Posted: 2015-10-12
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-06
• Last Update Posted: 2015-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo + background low to moderate dose statin	Statin	Placebo + background low to moderate dose statin Tablets, Oral, 0 mg, once daily, for 12 weeks
BMS-582949 + Background low to moderate dose statin	Statin	BMS-582949 + Background low to moderate dose statin Tablets, Oral, 100 mg, once daily for 12 weeks
Atorvastatin	Atorvastatin	Atorvastatin Tablets, oral, 80 mg once daily for 12 weeks
Placebo + background low to moderate dose statin	Placebo	Placebo + background low to moderate dose statin Tablets, Oral, 0 mg, once daily, for 12 weeks
BMS-582949 + Background low to moderate dose statin	BMS-582949	BMS-582949 + Background low to moderate dose statin Tablets, Oral, 100 mg, once daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
FDG-PET signal of the carotid and/or ascending aorta	at 4 and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Inflammatory and thrombotic biomarkers	will be measured throughout the 12 weeks of treatment

Trial Locations

Locations (16)

Florida Cardiovascular Institute; 🇺🇸 Tampa, Florida, United States

Troy Internal Medince Pc/Research; 🇺🇸 Troy, Michigan, United States

Baylor College Of Medicine; 🇺🇸 Houston, Texas, United States

Jacksonville Center For Clinical Research - Univ Campus; 🇺🇸 Jacksonville, Florida, United States

Radiant Research, Inc.; 🇺🇸 Dallas, 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

Mgh Cardiac Mr Pet Ct Program; 🇺🇸 Boston, Massachusetts, United States

Sterling Research Group; 🇺🇸 Cincinnati, Ohio, United States

Commonwealth Biomedical Research, Llc; 🇺🇸 Madisonville, Kentucky, United States

Metabolic And Atherosclerosis Research Center; 🇺🇸 Cincinnati, Ohio, United States

Southeast Clinical Research, Llc; 🇺🇸 Chiefland, Florida, United States

The Lipid Center; 🇺🇸 Statesville, North Carolina, United States

Phillip D. Toth, Md; 🇺🇸 Indianapolis, Indiana, United States

L-Marc Research Center; 🇺🇸 Louisville, Kentucky, United States

Mcallen Heart Clinic; 🇺🇸 Mc Allen, Texas, United States