Status:
COMPLETED
A Study Evaluating the Safety and Efficacy of AVE5530 (4 Weeks) in Patients With Mild to Moderate Hypercholesterolemia
Lead Sponsor:
Sanofi
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to assess the effect of AVE5530 on LDL-C levels over a period of 4 weeks. The secondary objectives are to assess the effects of AVE5530 on other lipid plasma lev...
Eligibility Criteria
Inclusion
- Patients with mild to moderate primary hypercholesterolemia with stabilized LDL-C baseline ≥130 mg/dL and ≤ 250 mg/dL (≥ 3.36 mmol/L and ≤ 6.46 mmol/L)
- Male aged ≥ 18 years or postmenopausal women at screening
Exclusion
- Presence of any clinically significant endocrine disease known to influence serum lipids or lipoproteins
- Patients with type 1 diabetes
- Presence or history of cancer within the past five years
- Triglycerides ≥ 300 mg/dL (3.39 mmol/L)
- Fasting plasma glucose \> 160 mg/dL (8.9 mmol/L)
- Impaired kidney function and active liver disease
- Within one month prior to screening visit and/or at the time or after the screening visit, administration of any lipid lowering treatment
- Creatine Kinase \> 2xUpper Limit of Normal range
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT00440154
Start Date
February 1 2007
End Date
October 1 2007
Last Update
December 16 2008
Active Locations (6)
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1
Sanofi-Aventis Administrative Office
Santiago, Chile
2
Sanofi-Aventis Administrative Office
Budapest, Hungary
3
Sanofi-Aventis Administrative Office
México, Mexico
4
Sanofi-Aventis Administrative Office
Moscow, Russia