Dose-Ranging Study Evaluating AVE1625 in Abdominally Obese Patients With Atherogenic Dyslipidemia
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ClinicalTrials.gov Identifier: NCT00345410 |
Recruitment Status :
Completed
First Posted : June 28, 2006
Last Update Posted : December 19, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity Dyslipidemia | Drug: AVE1625 B | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 345 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, 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 |
Study Start Date : | June 2006 |
Actual Primary Completion Date : | June 2007 |
Actual Study Completion Date : | June 2007 |
- Absolute change from baseline in body weight at 24 weeks
- - 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00345410
United States, New Jersey | |
Sanofi-Aventis Administrative Office | |
Bridgewater, New Jersey, United States, 08807 |
Principal Investigator: | Julio ROSENSTOCK, MD | Dallas Diabetes and Endocrine Center 7777 Forest Lane, C-618 Dallas TX 75230 USA |
Responsible Party: | ICD Study Director, sanofi-aventis |
ClinicalTrials.gov Identifier: | NCT00345410 |
Other Study ID Numbers: |
DRI6412 |
First Posted: | June 28, 2006 Key Record Dates |
Last Update Posted: | December 19, 2008 |
Last Verified: | December 2008 |
obesity and dyslipidemia |
Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |