NCT00459004已完成2 期
A Dose-Response Relationship Study of SR141716 in Obese Patients
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
- 527
- 试验地点
- 1
- 主要终点
- absolute change in body weight from baseline to Week 24
研究概览
简要总结
The primary objective is to verify the dose-response relationship of rimonabant on body weight change.
The secondary objectives are to compare the effect of 3 doses of SR141716 to placebo, on body weight loss and on secondary criteria associated with comorbidities, and to evaluate the safety and 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index ≥25 kg/m²
- •Viceral Fat Area ≥ 100 cm²
- •Diet therapy for more than 8 weeks before start of the placebo observation period
- •Stable weight (variation < ±3kg within 8 weeks before start of observation period)
- •At least 2 criteria of the following 3 comorbidities: Impaired Glucose Tolerance or Type 2 diabetes, Dyslipidemia (hypertriglyceridemia and/or low HDL-choresterol), Hypertension
排除标准
- 未提供
结局指标
主要结局
absolute change in body weight from baseline to Week 24
次要结局
- Efficacy: body weight, visceral fat area, waist circumference, fasting plasma glucose, HbA1c, triglyceride, HDL-cholesterol, blood pressure
- Safety:adverse events, laboratory tests, ECGs
- Pharmacokinetics: SR141716 plasma trough concentrations
研究者
研究点 (1)
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