Evaluation of Efficacy and Safety of AVE5530 Co-administered With Atorvastatin in Primary Hypercholesterolemia
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Hypercholesterolemia
In brief
The present study is assessing the efficacy and safety of AVE5530 (25mg and 50mg) co-administered with all approved doses of atorvastatin in a double-blind comparison with placebo, AVE5530 alone and atorvastatin alone in the management of patients with primary hypercholesterolemia. The main objective is to evaluate the effects of the association AVE5530+atorvastatin on LDL-C level reduction after 12 weeks of treatment. The effects of AVE5530+atorvastatin on other lipid parameters will be assessed as secondary objectives
Key facts
- Study ID
- NCT00741715
- Run by
- Sanofi
- People needed
- 1736
- Starts
- 2008-08-01
- Expected to finish
- 2009-06-01
- Last updated by the study team
- 2016-05-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults with high cholesterol levels either not receiving or willing and able to discontinue ongoing lipid-lowering therapy
You may not qualify if…
- 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
- Hypersensitivity to any component of atorvastatin
- Concurrent administration of Cytochrome P450 3A4 inhibitors (e.g. cyclosporine, erythromycin, clarithromycin, and azole antifungals) should be avoided as increasing the risk of myopathy with atorvastatin
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Where it is running
- Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
- Sanofi-Aventis Administrative Office — San Juan, Puerto Rico
Full record on ClinicalTrials.gov
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