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

Phase 3

Terminated

• Conditions: Hypercholesterolemia
• Interventions: Drug: AVE5530; Drug: Placebo

• Registration Number: NCT00718965
• Lead Sponsor: Sanofi

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-18
• Study First Submitted QC: 2008-07-18
• Study First Posted: 2008-07-21
• Primary Completion: 2008-11
• Study Completion: 2009-06
• Status Verified: 2016-04
• Disposition First Submitted: 2016-04-15
• Disposition First Submitted QC: 2016-04-15
• Last Update Submitted: 2016-04-15
• Disposition First Posted: 2016-05-16
• Last Update Posted: 2016-05-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 826

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
25 mg/day AVE5530	AVE5530	-
50 mg/day AVE5530	AVE5530	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
percent change from baseline in calculated LDL-C	at week 12

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇵🇷 Puerto Rico, Puerto Rico