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

February 23, 2007
December 15, 2008
February 2007
October 2007   (final data collection date for primary outcome measure)
Percent change in LDL-C from baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Efficacy: percent change in LDL-C from baseline to 4 weeks
Complete list of historical versions of study NCT00440154 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Efficacy: absolute change from in LDL-C levels and percent change in other lipids and lipoprotein fractions from baseline to 4 weeks
  • Safety: physical examination, vital signs, adverse events,hematology, serum chemistry
Not Provided
Not Provided
 
A Study Evaluating the Safety and Efficacy of AVE5530 (4 Weeks) in Patients With Mild to Moderate Hypercholesterolemia
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypercholesterolemia
  • Drug: AVE5530
  • Drug: placebo
  • Drug: ezetimibe
  • Experimental: 1
    oral administration 5 mg breakfast timing
    Intervention: Drug: AVE5530
  • Experimental: 2
    oral administration 25 mg breakfast timing
    Intervention: Drug: AVE5530
  • Experimental: 3
    oral administration 50 mg breakfast timing
    Intervention: Drug: AVE5530
  • Experimental: 4
    oral administration 100 mg breakfast timing
    Intervention: Drug: AVE5530
  • Experimental: 5
    oral administration 25 mg dinner timing
    Intervention: Drug: AVE5530
  • Placebo Comparator: 6
    oral administration
    Intervention: Drug: placebo
  • Active Comparator: 7
    oral administration 10mg breakfast timing
    Intervention: Drug: ezetimibe
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
206
October 2007
October 2007   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Chile,   Hungary,   Korea, Republic of,   Mexico,   Russian Federation,   Turkey
 
NCT00440154
DRI6589, EudraCT: 2006-005469-20
Not Provided
ICD Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: ICD CSD Sanofi
Sanofi
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP