Evaluation of Efficacy and Safety of AVE5530 in Patients With Primary Hypercholesterolemia

Study Overview
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Brief Summary
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The present study is aiming at assessing the efficacy and safety of AVE5530 (25mg and 50mg) in a double-blind comparison with placebo in the management of patients with primary hypercholesterolemia. The main objective is to evaluate the effects of AVE5530 on LDL-C level reduction as adjunct to a controlled diet. The effects of AVE5530 on other lipid parameters will be assessed as secondary objectives.

Detailed Description
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The study will include a 2-week pre-randomization placebo lead-in phase and a double-blind treatment period of at least 12 months and can be variably extended up to approximately 18 months.

Official Title
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A Double-blind, Randomized, 12-month, Placebo-controlled, Parallel Group, Fixed-dose Study to Evaluate the Efficacy and Safety of AVE5530 25mg/Day and AVE5530 50 mg/Day in Patients With Primary Hypercholesterolemia

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: AVE5530
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with high cholesterol levels either not receiving or willing and able to discontinue ongoing lipid-lowering therapy Exclusion Criteria: LDL-C levels > 250 mg/dL (6.48 mmol/L) Triglycerides levels > 350mg/dL (3.95 mmol/L) Conditions / situations such as: presence of any clinically significant uncontrolled endocrine disease known to influence lipids levels Active liver disease High estimated risk of Coronary Heart Disease Recent history of congestive heart failure , of unstable angina pectoris, myocardial infarction, coronary bypass surgery or angioplasty, or Unstable or severe peripheral artery disease Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody or Known to be Human Immunodeficient Virus (HIV) positive Pregnant or breast-feeding women, Women of childbearing potential not protected by effective contraceptive method of birth control (including oral contraceptives) and/or who are unwilling or unable to be tested for pregnancy prior to exposure to the Investigational Product. 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 25 mg/day AVE5530<br> | Drug: AVE5530<br>* one tablet in the evening with dinner<br>|
| Experimental: 50 mg/day AVE5530<br> | Drug: AVE5530<br>* one tablet in the evening with dinner<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* one tablet in the evening with dinner<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent change from baseline in calculated LDL-C |  | at week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent change from baseline in calculated LDL-C |  | at 6 months and 12 months | 
| percent change from baseline in total cholesterol and Apo-B |  | at 12 weeks, 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary hypercholesterolemia