Evaluation of Efficacy and Safety of AVE5530 Co-administered With Atorvastatin in Primary Hypercholesterolemia

Hypercholesterolemia Clinical Trial

Official title:

A Multicenter, Randomized, Placebo-controlled, "Factorial" Design, 12-month Study to Evaluate the Efficacy and Safety of AVE5530 25 mg/Day and 50 mg/Day Co-administered With All Registered Atorvastatin Strengths Ranging From 10 mg to 80 mg in Patients With Primary Hypercholesterolemia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00741715
• Other study ID #: EFC6911
• Status: Terminated
• Phase: Phase 3
• First received: August 25, 2008
• Last updated: November 10, 2009
• Start date: August 2008
• Est. completion date: June 2009

Study information

• Verified date: November 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The present study is assessing the efficacy and safety of AVE5530 (25mg and 50mg) co-administered with all approved doses of atorvastatin in a double-blind comparison with placebo, AVE5530 alone and atorvastatin alone in the management of patients with primary hypercholesterolemia. The main objective is to evaluate the effects of the association AVE5530+atorvastatin on LDL-C level reduction after 12 weeks of treatment. The effects of AVE5530+atorvastatin on other lipid parameters will be assessed as secondary objectives

Description:

The study will include a 2 week pre-randomization placebo lead-in phase. There will be a 12- week double-blind treatment period for both components AVE5530 and atorvastatin, followed by a 40-week period with maintenance of double-blind design for AVE5530 component and open label for atorvastatin component transitioning at 20 mg for all patients with subsequent titration, if necessary, based on regular LDL-cholesterol monitoring. The treatment period can be variably extended up to approximately 18 months with double-blind for AVE5530 component and open-label for atorvastatin.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1736
• Est. completion date: June 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

• Hypersensitivity to any component of atorvastatin

• Concurrent administration of Cytochrome P450 3A4 inhibitors (e.g. cyclosporine, erythromycin, clarithromycin, and azole antifungals) should be avoided as increasing the risk of myopathy with atorvastatin

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• AVE5530
oral administration once daily in the evening with dinner
• atorvastatin
oral administration once daily in the evening with dinner
• placebo
oral administration once daily in the evening with dinner

Locations

Country	Name	City	State
Puerto Rico	Sanofi-Aventis Administrative Office	Puerto Rico
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from baseline in calculated LDL-C		At week 12	No
Secondary	Percent change from baseline in calculated LDL-C		At 6 months and 12 months	No
Secondary	Percent change from baseline in total cholesterol, HDL-C, TG, Apo-A1, Apo-B and CRP		At week 12, 6 months and 12 months	No