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Completed

NCT Number: NCT00345410

Dose-Ranging Study Evaluating AVE1625 in Abdominally Obese Patients With Atherogenic Dyslipidemia

Primary objective: to assess the effect of AVE1625 on weight loss over a period of 24 weeks in abdominally obese patients with atherogenic dyslipidemia. Secondary objectives: - To assess the dose effect relationship of AVE1625 on HDL-cholesterol and triglycerides plasma levels over a period of 24 weeks - To assess the efficacy of AVE1625 on secondary parameters such as waist circumference and other metabolic parameters over a period of 24 weeks - To assess the safety and tolerabillity of AVE1625 over a period of 24 weeks.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, 08807, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Abdominal obese patients with ·
  • Waist circumference > 102 cm in men and >88 cm in women
  • Dyslipidemia consisting of :
  • Triglycerides ≥ 1.50 g/L (i.e 1.69 mmol/L) and ≤ 7.0 g/L(i.e. 7.90 mmol/L)AND/OR
  • HDL-cholesterol < 50 mg/dL (i.e. 1.29 mmol/L) in women and < 40 mg/dL (i.e. 1.04 mmol/L) in men

Exclusion criteria

  • Pregnancy or lactation
  • Women of child-bearing potential with no medically approved contraception
  • Patients with type 1 diabetes
  • Patients with type 2 diabetes must be on a stable dose of oral antidiabetic drugs (excluding glitazones, exenatide, sulfonylurea and nateglinide) and should not receive insulin therapy
  • Patients with any clinically significant endocrine disease
  • Patients on anticoagulants (heparin, warfarin) or with bleeding disorders
  • Clinically relevant disease interfering with subject's safety or making implementation of the study protocol or interpretation of study results difficult
  • Patients with mental retardation or any clinically significant psychiatric disorder
  • History or concurrent substance abuse (other than nicotine or caffeine especially marijuana or hashish)
  • Chronic systemic corticotherapy
  • Patients with weight change > 5kg within 3 months prior to screening
  • Patients should not have received anti-obesity drugs or other drugs for weight reduction in the 3 months prior to screening.
  • The investigator will evaluate whether there are other reasons why a patient may not participate

Treatment and study plan

AVE1625 B

Drug

Primary outcomes

  1. Absolute change from baseline in body weight at 24 weeks

Secondary outcomes

  1. - relative change from baseline to 24 weeks in plasma HDL-cholesterol and triglycerides levels ; - change from baseline to 24 weeks in waist circumference ; Other criteria: glycemic control parameters.

  2. Safety: physical examination, vital signs, adverse events, ECG, laboratory tests.

  3. Pharmacokinetics: plasma AVE1625 concentrations

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Three Doses of AVE1625 in Abdominally Obese Patients With Atherogenic Dyslipidemia

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jun 28, 2006
Registry last updated
Dec 19, 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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