NCT00434096终止3 期
A Randomized Double-blind, Placebo-controlled, Parallel-group, Fixed Single-dose Regimen (SR141716 20 mg), Multicenter Study to Assess the Efficacy and Safety of SR141716 in Obese Patients With Dyslipidemia.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 915
- 试验地点
- 1
- 主要终点
- body weight: relative change from baseline
研究概览
简要总结
The primary objective of this study is to assess the efficacy of SR141716 compared to placebo on body weight and triglycerides changes over a period of 52 weeks.
Secondary objectives are:
- To evaluate the effect of SR141716 compared to placebo over a period of 52 weeks, on HDL-cholesterol and visceral fat area.
- To evaluate the safety of SR141716 compared to placebo over a period of 104 weeks.
- To evaluate the pharmacokinetics of SR141716.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index (BMI) > 25 kg/m²
- •Visceral Fat Area (VFA) > 100 cm²
- •Triglycerides (TG) > 150 mg/dL and < 700 mg/dL, and/or HDL-cholesterol < 40 mg/dL(Dyslipidemia)
- •At least 1 criteria of the following 2 comorbidities:
- •Impaired Glucose Tolerance or Type 2 diabetes
- •Hypertension
排除标准
- •Patient with a secondary obesity.
- •Patients who have received the diet therapy for less than 8 weeks before start of the observation period.
- •Patients whose body weight changed by more than the variation of ± 2kg for screening period.
- •Low compliance to drug intake (< 80%) and dietary instruction during the observation period.
- •Patients with type 1 diabetes.
- •Patients with a primary hyperlipidemia (i.e., familial hypercholesterolemia, familial combined hyperlipidemia and familial type III hyperlipidemia).
- •Patients with a LDL-cholesterol > 190 mg/dL at any of Weeks -8 or -
- •Patients with a secondary hypertension.
研究组 & 干预措施
1
Experimental
干预措施: rimonabant (SR141716) (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
body weight: relative change from baseline
时间窗: Week 52
triglycerides: relative change from baseline
时间窗: Week 52
次要结局
- HDL-cholesterol ;visceral fat area(Week 52)
- Safety: Adverse events(study period)
研究者
研究点 (1)
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