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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345410
• Other study ID #: DRI6412
• Status: Completed
• Phase: Phase 2
• First received: June 27, 2006
• Last updated: December 18, 2008
• Start date: June 2006
• Est. completion date: June 2007

Study information

• Verified date: December 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Obesity

Intervention

Drug:
• AVE1625 B

Locations

Country	Name	City	State
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change from baseline in body weight at 24 weeks
Secondary	- 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.
Secondary	Safety: physical examination, vital signs, adverse events, ECG, laboratory tests.
Secondary	Pharmacokinetics: plasma AVE1625 concentrations

External Links

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