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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00345410
First received: June 27, 2006
Last updated: December 18, 2008
Last verified: December 2008

June 27, 2006
December 18, 2008
June 2006
June 2007   (final data collection date for primary outcome measure)
Absolute change from baseline in body weight at 24 weeks
Same as current
Complete list of historical versions of study NCT00345410 on ClinicalTrials.gov Archive Site
  • - 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.
  • Safety: physical examination, vital signs, adverse events, ECG, laboratory tests.
  • Pharmacokinetics: plasma AVE1625 concentrations
Same as current
Not Provided
Not Provided
 
Dose-Ranging Study Evaluating AVE1625 in Abdominally Obese Patients With Atherogenic Dyslipidemia
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Obesity
  • Dyslipidemia
Drug: AVE1625 B
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
345
June 2007
June 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00345410
DRI6412
Not Provided
ICD Study Director, sanofi-aventis
Sanofi
Not Provided
Principal Investigator: Julio ROSENSTOCK, MD Dallas Diabetes and Endocrine Center 7777 Forest Lane, C-618 Dallas TX 75230 USA
Sanofi
December 2008

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