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Bridgewater, New Jersey 08807


Purpose:

The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on to ongoing statin treatment in a double-blind manner in comparison with placebo, in the management of patients with primary hypercholesterolemia considered as inadequately controlled despite their ongoing statin treatment. The main objective is to evaluate the effects of the association AVE5530+statin on LDL-C level reduction after 12 weeks of treatment. The effects of AVE5530 on other lipid parameters will be assessed as secondary objectives.


Study summary:

The two doses of AVE5530 tested in this study are 25 mg and 50 mg taken in the evening, with dinner dosing. The study will include a screening phase up to 2 weeks, 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 cholesterol levels not controlled on ongoing stable statin treatment Exclusion Criteria: - LDL-C levels > 250 mg/dL (6.48 mmol/L) - Triglycerides >350 mg/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 - 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:

NCT00729027


Primary Contact:

Principal Investigator
Mats ERICKSSON, MD
Department of Endocrinology, Metabolism and Diabetes, Karolinska University Hospital, Huddinge, Swed


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: January 23, 2018

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