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

April 15, 2016 updated by: Sanofi

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

826

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Puerto Rico, Puerto Rico
        • Sanofi-Aventis Administrative Office
  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
one tablet in the evening with dinner
Experimental: 25 mg/day AVE5530
Drug: AVE5530
one tablet in the evening with dinner
Experimental: 50 mg/day AVE5530
Drug: AVE5530
one tablet in the evening with dinner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
percent change from baseline in calculated LDL-C
Time Frame: at week 12
at week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
percent change from baseline in calculated LDL-C
Time Frame: at 6 months and 12 months
at 6 months and 12 months
percent change from baseline in total cholesterol and Apo-B
Time Frame: at 12 weeks, 6 months and 12 months
at 12 weeks, 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Principal Investigator: John CROUSE, MD, Wake Forest University Health Sciences, North Carolina, US

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

July 18, 2008

First Submitted That Met QC Criteria

July 18, 2008

First Posted (Estimate)

July 21, 2008

Study Record Updates

Last Update Posted (Estimate)

May 16, 2016

Last Update Submitted That Met QC Criteria

April 15, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC6909

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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