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

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ClinicalTrials.gov Identifier: NCT00718965
Recruitment Status : Terminated (AVE5530 in hypercholesterolemia was stopped due to insufficient efficacy)
First Posted : July 21, 2008
Last Update Posted : May 16, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: AVE5530 Drug: Placebo Phase 3

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  (Clinical Trial)
Actual Enrollment : 826 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : July 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
Placebo Comparator: Placebo Drug: Placebo
one tablet in the evening with dinner



Primary Outcome Measures :
  1. percent change from baseline in calculated LDL-C [ Time Frame: at week 12 ]

Secondary Outcome Measures :
  1. percent change from baseline in calculated LDL-C [ Time Frame: at 6 months and 12 months ]
  2. percent change from baseline in total cholesterol and Apo-B [ Time Frame: at 12 weeks, 6 months and 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00718965     History of Changes
Other Study ID Numbers: EFC6909
First Posted: July 21, 2008    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: April 2016

Keywords provided by Sanofi:
Primary hypercholesterolemia

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