search
Back to results

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

Primary Purpose

Obesity, Dyslipidemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AVE1625 B
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity and dyslipidemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sanofi-Aventis Administrative Office

Outcomes

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

Full Information

First Posted
June 27, 2006
Last Updated
December 18, 2008
Sponsor
Sanofi
search

1. Study Identification

Unique Protocol Identification Number
NCT00345410
Brief Title
Dose-Ranging Study Evaluating AVE1625 in Abdominally Obese Patients With Atherogenic Dyslipidemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Dyslipidemia
Keywords
obesity and dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
345 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
AVE1625 B
Primary Outcome Measure Information:
Title
Absolute change from baseline in body weight at 24 weeks
Secondary Outcome Measure Information:
Title
- 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.
Title
Safety: physical examination, vital signs, adverse events, ECG, laboratory tests.
Title
Pharmacokinetics: plasma AVE1625 concentrations

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julio ROSENSTOCK, MD
Organizational Affiliation
Dallas Diabetes and Endocrine Center 7777 Forest Lane, C-618 Dallas TX 75230 USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.sanofi-aventis.com
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs