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

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Ezetimibe

Criteria

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.