A Study Evaluating the Safety and Efficacy of AVE5530 (4 Weeks) in Patients With Mild to Moderate Hypercholesterolemia

Phase 2

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: AVE5530; Drug: placebo; Drug: ezetimibe

• Registration Number: NCT00440154
• Lead Sponsor: Sanofi

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 levels and the safety and tolerability of AVE5530.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-02-23
• Study First Submitted QC: 2007-02-23
• Study First Posted: 2007-02-26
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-15
• Last Update Posted: 2008-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	AVE5530	oral administration 50 mg breakfast timing
4	AVE5530	oral administration 100 mg breakfast timing
1	AVE5530	oral administration 5 mg breakfast timing
2	AVE5530	oral administration 25 mg breakfast timing
5	AVE5530	oral administration 25 mg dinner timing
6	placebo	oral administration
7	ezetimibe	oral administration 10mg breakfast timing

Primary Outcome Measures

Name	Time	Method
Percent change in LDL-C from baseline	4 weeks

Secondary Outcome Measures

Name	Time	Method
Absolute change from in LDL-C levels	4 weeks
Percent change in other lipids and lipoprotein fractions from baseline	4 weeks

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇹🇷 Istanbul, Turkey