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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: February 23, 2007
Last updated: December 15, 2008
Last verified: December 2008

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.

Condition Intervention Phase
Drug: AVE5530
Drug: placebo
Drug: ezetimibe
Phase 2

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

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percent change in LDL-C from baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute change from in LDL-C levels [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Percent change in other lipids and lipoprotein fractions from baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 206
Study Start Date: February 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
oral administration 5 mg breakfast timing
Drug: AVE5530
Experimental: 2
oral administration 25 mg breakfast timing
Drug: AVE5530
Experimental: 3
oral administration 50 mg breakfast timing
Drug: AVE5530
Experimental: 4
oral administration 100 mg breakfast timing
Drug: AVE5530
Experimental: 5
oral administration 25 mg dinner timing
Drug: AVE5530
Placebo Comparator: 6
oral administration
Drug: placebo
Active Comparator: 7
oral administration 10mg breakfast timing
Drug: ezetimibe


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00440154

Sanofi-Aventis Administrative Office
Santiago, Chile
Sanofi-Aventis Administrative Office
Budapest, Hungary
Korea, Republic of
Sanofi-Aventis Administrative Office
Seoul, Korea, Republic of
Sanofi-Aventis Administrative Office
Mexico, Mexico
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Sanofi-Aventis Administrative Office
Istanbul, Turkey
Sponsors and Collaborators
Study Director: ICD CSD Sanofi
  More Information

Additional Information:
No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00440154     History of Changes
Other Study ID Numbers: DRI6589, EudraCT: 2006-005469-20
Study First Received: February 23, 2007
Last Updated: December 15, 2008
Health Authority: Chile: Instituto de Salud Publica de Chile

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014