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

Hypercholesterolemia Clinical Trial

Official title:

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled,Ezetimibe-Calibrated, Multicenter Study Evaluating the Safety and Efficacy of Four Doses and Two Dose-Regimens of AVE5530 Over 4 Weeks in Patients With Mild to Moderate Primary Hypercholesterolemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00440154
• Other study ID #: DRI6589
• Secondary ID: EudraCT: 2006-00
• Status: Completed
• Phase: Phase 2
• First received: February 23, 2007
• Last updated: December 15, 2008
• Start date: February 2007
• Est. completion date: October 2007

Study information

• Verified date: December 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Instituto de Salud Pública de Chile
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• AVE5530

• placebo

• ezetimibe

Locations

Country	Name	City	State
Chile	Sanofi-Aventis Administrative Office	Santiago
Hungary	Sanofi-Aventis Administrative Office	Budapest
Korea, Republic of	Sanofi-Aventis Administrative Office	Seoul
Mexico	Sanofi-Aventis Administrative Office	Mexico
Russian Federation	Sanofi-Aventis Administrative Office	Moscow
Turkey	Sanofi-Aventis Administrative Office	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Chile,  Hungary,  Korea, Republic of,  Mexico,  Russian Federation,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in LDL-C from baseline		4 weeks	No
Secondary	Absolute change from in LDL-C levels		4 weeks	No
Secondary	Percent change in other lipids and lipoprotein fractions from baseline		4 weeks	No

External Links

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