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

This study has been terminated.
(AVE5530 in hypercholesterolemia was stopped due to insufficient efficacy)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00718965
First received: July 18, 2008
Last updated: September 22, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Hypercholesterolemia
Drug: AVE5530
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • percent change from baseline in calculated LDL-C [ Time Frame: at week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • percent change from baseline in calculated LDL-C [ Time Frame: at 6 months and 12 months ] [ Designated as safety issue: No ]
  • percent change from baseline in total cholesterol and Apo-B [ Time Frame: at 12 weeks, 6 months and 12 months ] [ Designated as safety issue: No ]

Enrollment: 826
Study Start Date: July 2008
Study Completion Date: June 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
25mg/day
Drug: AVE5530
one tablet in the evening with dinner
Experimental: 2
50 mg/day
Drug: AVE5530
one tablet in the evening with dinner
Placebo Comparator: 3 Drug: Placebo
one tablet in the evening with dinner

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00718965

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Puerto Rico
Sanofi-Aventis Administrative Office
Puerto Rico, Puerto Rico
Sponsors and Collaborators
Sanofi
Investigators
Principal Investigator: John CROUSE, MD Wake Forest University Health Sciences, North Carolina, US
  More Information

No publications provided

Responsible Party: ICD CSD, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00718965     History of Changes
Other Study ID Numbers: EFC6909
Study First Received: July 18, 2008
Last Updated: September 22, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Primary hypercholesterolemia

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014