Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Vascular Diseases

Treatments: Drug: BMS-582949; Other: Placebo; Drug: Statin; Drug: Atorvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00570752

IM119-014

Details and patient eligibility

About

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

Enrollment: 72 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 3 patient groups

Placebo + background low to moderate dose statin

Active Comparator group

Description:

Placebo + background low to moderate dose statin Tablets, Oral, 0 mg, once daily, for 12 weeks

Treatment:

Drug: Statin

Other: Placebo

BMS-582949 + Background low to moderate dose statin

Experimental group

Description:

BMS-582949 + Background low to moderate dose statin Tablets, Oral, 100 mg, once daily for 12 weeks

Treatment:

Drug: Statin

Drug: BMS-582949

Atorvastatin

Active Comparator group

Description:

Atorvastatin Tablets, oral, 80 mg once daily for 12 weeks

Treatment:

Drug: Atorvastatin