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Completed

NCT Number: NCT00440154

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

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis Administrative Office, Santiago, Chile

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AVE5530

Drug

Placebo

Drug

ezetimibe

Drug

Primary outcomes

  1. Percent change in LDL-C from baseline

    Time frame: 4 weeks

Secondary outcomes

  1. Absolute change from in LDL-C levels

    Time frame: 4 weeks

  2. Percent change in other lipids and lipoprotein fractions from baseline

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Feb 26, 2007
Registry last updated
Dec 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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