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

• Absolute change from in LDL-C levels [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
• Percent change in other lipids and lipoprotein fractions from baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

• Efficacy: absolute change from in LDL-C levels and percent change in other lipids and lipoprotein fractions from baseline to 4 weeks
• Safety: physical examination, vital signs, adverse events,hematology, serum chemistry

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.

• Drug: AVE5530
• Drug: placebo
• Drug: ezetimibe

• Experimental: 1
  oral administration 5 mg breakfast timing
  Intervention: Drug: AVE5530
• Experimental: 2
  oral administration 25 mg breakfast timing
  Intervention: Drug: AVE5530
• Experimental: 3
  oral administration 50 mg breakfast timing
  Intervention: Drug: AVE5530
• Experimental: 4
  oral administration 100 mg breakfast timing
  Intervention: Drug: AVE5530
• Experimental: 5
  oral administration 25 mg dinner timing
  Intervention: Drug: AVE5530
• Placebo Comparator: 6
  oral administration
  Intervention: Drug: placebo
• Active Comparator: 7
  oral administration 10mg breakfast timing
  Intervention: Drug: ezetimibe

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.