Dose-Ranging Study Evaluating AVE1625 in Abdominally Obese Patients With Atherogenic Dyslipidemia
Completed · Phase 2
Conditions studied: Obesity, Dyslipidemia
In brief
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.
Key facts
- Study ID
- NCT00345410
- Run by
- Sanofi
- People needed
- 345
- Starts
- 2006-06-01
- Expected to finish
- 2007-06-01
- Last updated by the study team
- 2008-12-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
Full record on ClinicalTrials.gov
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