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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

345 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Dyslipidemia

Keywords

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obesity and dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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AVE1625 B

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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sanofi-aventis

Principal Investigators

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Julio ROSENSTOCK, MD

Role: PRINCIPAL_INVESTIGATOR

Dallas Diabetes and Endocrine Center 7777 Forest Lane, C-618 Dallas TX 75230 USA

Locations

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Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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DRI6412

Identifier Type: -

Identifier Source: org_study_id