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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: AVE5530
* Drug: placebo
* Drug: ezetimibe


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>oral administration 5 mg breakfast timing | Drug: AVE5530<br> <br> |
| Experimental: 2<br>oral administration 25 mg breakfast timing | Drug: AVE5530<br> <br> |
| Experimental: 3<br>oral administration 50 mg breakfast timing | Drug: AVE5530<br> <br> |
| Experimental: 4<br>oral administration 100 mg breakfast timing | Drug: AVE5530<br> <br> |
| Experimental: 5<br>oral administration 25 mg dinner timing | Drug: AVE5530<br> <br> |
| Placebo Comparator: 6<br>oral administration | Drug: placebo<br> <br> |
| Active Comparator: 7<br>oral administration 10mg breakfast timing | Drug: ezetimibe<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in LDL-C from baseline |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change from in LDL-C levels |  | 4 weeks | 
| Percent change in other lipids and lipoprotein fractions from baseline |  | 4 weeks |