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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00718965
• Other study ID #: EFC6909
• Status: Terminated
• Phase: Phase 3
• First received: July 18, 2008
• Last updated: September 22, 2009
• Start date: July 2008
• Est. completion date: June 2009

Study information

• Verified date: September 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 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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 826
• Est. completion date: June 2009
• Est. primary completion date: November 2008
• 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.

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: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• AVE5530
one tablet in the evening with dinner
• Placebo
one tablet 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 and Apo-B		at 12 weeks, 6 months and 12 months	No