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

NCT00345410 | Completed Phase 2

• 1 other identifier: DRI6412
• Study Type: interventional
• Target: 345
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Dyslipidemia

Keywords

obesity and dyslipidemia

Outcome Measures

Primary Outcomes (1)

• Absolute change from baseline in body weight at 24 weeks

Secondary Outcomes (3)

• - 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

Interventions

AVE1625 B DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, 08807, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Obesity; Dyslipidemias

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders; Metabolic Diseases

Study Officials

• Julio ROSENSTOCK, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 27, 2006
• First Posted: June 28, 2006
• Study Start: June 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: December 19, 2008

Record last verified: 2008-12

Locations

US (1)