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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014