drugset / Trial / NCT00741715
Evaluation of Efficacy and Safety of AVE5530 Co-administered With Atorvastatin in Primary Hypercholesterolemia
RandomizedFactorialTriple-blindTreatment
Summary
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
Timeline
- Start
- 2008-08
- Primary completion
- 2009-05
- Completion
- 2009-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atorvastatin | Small molecule | 10 mg | Oral |
| Subject | Atorvastatin | Small molecule | 20 mg | Oral |
| Subject | Atorvastatin | Small molecule | 40 mg | Oral |
| Subject | Atorvastatin | Small molecule | 80 mg | Oral |
| Subject | CANOSIMIBE | Small molecule | 25 mg | Oral |
| Subject | CANOSIMIBE | Small molecule | 50 mg | Oral |