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Bridgewater, New Jersey 08807


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.


Study summary:

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.


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.


NCT ID:

NCT00718965


Primary Contact:

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


Backup Contact:

N/A


Location Contact:

Bridgewater, New Jersey 08807
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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