Clinical trial NCT00345410: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Dyslipidemia
Keywords: obesity and dyslipidemia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-06-28
Enrollment: 345
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Absolute change from baseline in body weight at 24 weeks
Secondary outcomes:
measure: - 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.
measure: Safety: physical examination, vital signs, adverse events, ECG, laboratory tests.
measure: Pharmacokinetics: plasma AVE1625 concentrations
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
Study officials:
affiliation: Dallas Diabetes and Endocrine Center 7777 Forest Lane, C-618 Dallas TX 75230 USA
name: Julio ROSENSTOCK, MD
role: PRINCIPAL_INVESTIGATOR
References: