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
  Purpose

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.


Condition Intervention Phase
Obesity
Dyslipidemia
Drug: AVE1625 B
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Absolute change from baseline in body weight at 24 weeks

Secondary Outcome Measures:
  • - 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

Enrollment: 345
Study Start Date: June 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345410

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
Principal Investigator: Julio ROSENSTOCK, MD Dallas Diabetes and Endocrine Center 7777 Forest Lane, C-618 Dallas TX 75230 USA
  More Information

Additional Information:
No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00345410     History of Changes
Other Study ID Numbers: DRI6412
Study First Received: June 27, 2006
Last Updated: December 18, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
obesity and dyslipidemia

Additional relevant MeSH terms:
Obesity
Dyslipidemias
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 25, 2014