NCT00345410已完成2 期
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
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 345
- 试验地点
- 2
- 主要终点
- Absolute change from baseline in body weight at 24 weeks
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Absolute change from baseline in body weight at 24 weeks
次要结局
- - 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
研究者
研究点 (2)
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