Status:
COMPLETED
Dose-Ranging Study Evaluating AVE1625 in Abdominally Obese Patients With Atherogenic Dyslipidemia
Lead Sponsor:
Sanofi
Conditions:
Obesity
Dyslipidemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 effe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
345 Patients enrolled
Trial Details
Trial ID
NCT00345410
Start Date
June 1 2006
End Date
June 1 2007
Last Update
December 19 2008
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807