Evaluation of Safety and Efficacy of AVE5530 as add-on to Ongoing Statins in Patients With Primary Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on to ongoing statin treatment in a double-blind manner in comparison with placebo, in the management of patients with primary hypercholesterolemia considered as inadequately controlled despite their ongoing statin treatment. The main objective is to evaluate the effects of the association AVE5530+statin on LDL-C level reduction after 12 weeks of treatment. The effects of AVE5530 on other lipid parameters will be assessed as secondary objectives.

Detailed Description
-----------------
The two doses of AVE5530 tested in this study are 25 mg and 50 mg taken in the evening, with dinner dosing. The study will include a screening phase up to 2 weeks, a double-blind treatment period of at least 12 months and can be variably extended up to approximately 18 months.

Official Title
-----------------
A Multicenter, Double-blind, Randomized, 12-month, Placebo-controlled Study to Evaluate the Lipid-lowering Effect, Safety and Tolerability of AVE5530 25 mg/Day and 50mg/Day When Added to Ongoing Stable Statin Therapy (HMG-CoA Reductase Inhibitors) in Patients With Primary Hypercholesterolemia

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: 25 mg/day AVE5530
* Drug: 50 mg/day AVE5530
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with cholesterol levels not controlled on ongoing stable statin treatment Exclusion Criteria: LDL-C levels > 250 mg/dL (6.48 mmol/L) Triglycerides >350 mg/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 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
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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: 25 mg/day AVE5530<br>* one tablet in the evening with dinner in addition to statin treatment (HMG-CoA Reductase Inhibitors)<br>|
| Experimental: 50 mg/day AVE5530<br> | Drug: 50 mg/day AVE5530<br>* one tablet in the evening with dinner in addition to statin treatment (HMG-CoA Reductase Inhibitors)<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* one tablet in the evening with dinner in addition to statin treatment (HMG-CoA Reductase Inhibitors)<br>|

What is the study measuring?
-----------------
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
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypercholesterolemia