A Study Evaluating the Safety and Efficacy of AVE5530 (4 Weeks) in Patients With Mild to Moderate Hypercholesterolemia

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled,Ezetimibe-Calibrated, Multicenter Study Evaluating the Safety and Efficacy of Four Doses and Two Dose-Regimens of AVE5530 Over 4 Weeks in Patients With Mild to Moderate Primary Hypercholesterolemia

The primary objective of this study is to assess the effect of AVE5530 on LDL-C levels over a period of 4 weeks. The secondary objectives are to assess the effects of AVE5530 on other lipid plasma levels and the safety and tolerability of AVE5530.

Inclusion Criteria:

• Patients with mild to moderate primary hypercholesterolemia with stabilized LDL-C baseline ≥130 mg/dL and ≤ 250 mg/dL (≥ 3.36 mmol/L and ≤ 6.46 mmol/L)
• Male aged ≥ 18 years or postmenopausal women at screening

Exclusion Criteria:

• Presence of any clinically significant endocrine disease known to influence serum lipids or lipoproteins
• Patients with type 1 diabetes
• Presence or history of cancer within the past five years
• Triglycerides ≥ 300 mg/dL (3.39 mmol/L)
• Fasting plasma glucose > 160 mg/dL (8.9 mmol/L)
• Impaired kidney function and active liver disease
• Within one month prior to screening visit and/or at the time or after the screening visit, administration of any lipid lowering treatment
• Creatine Kinase > 2xUpper Limit of Normal range

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.