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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00440154
First received: February 23, 2007
Last updated: December 15, 2008
Last verified: December 2008
  Purpose

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
Hypercholesterolemia
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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Chile
Sanofi-Aventis Administrative Office
Santiago, Chile
Hungary
Sanofi-Aventis Administrative Office
Budapest, Hungary
Korea, Republic of
Sanofi-Aventis Administrative Office
Seoul, Korea, Republic of
Mexico
Sanofi-Aventis Administrative Office
Mexico, Mexico
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Turkey
Sanofi-Aventis Administrative Office
Istanbul, Turkey
Sponsors and Collaborators
Sanofi
Investigators
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 Pública de Chile

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

ClinicalTrials.gov processed this record on September 18, 2014