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

Phase 3

Terminated

• Conditions: Hypercholesterolemia
• Interventions: Drug: 25 mg/day AVE5530; Drug: 50 mg/day AVE5530; Drug: placebo

• Registration Number: NCT00729027
• Lead Sponsor: Sanofi

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-08-01
• Study First Submitted QC: 2008-08-05
• Study First Posted: 2008-08-06
• Primary Completion: 2009-06
• 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: 1015

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
25 mg/day AVE5530	25 mg/day AVE5530	-
50 mg/day AVE5530	50 mg/day 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 (2)

sanofi-aventis Australia & New Zealand administrative office; 🇦🇺 Macquarie Park, New South Wales, Australia

Sanofi-Aventis Administrative Office; 🇸🇪 Bromma, Sweden