NCT00481923已完成3 期
A Randomized, Double-Bind, Placebo-Controlled, Parallel-Group, Fixed-Dose (20 mg/Day), 3-Month, Multicenter Study of the Energy Intake Effects and Safety of SR141716 With or Without Hypocaloric Diet in Obese Patients
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Absolute change from baseline in energy intake during ad-libitum dinner of the high-fat probe day at Weeks 3/4 of double-blind treatment.
研究概览
简要总结
The primary objective of this study is to assess the effect of rimonabant on the energy intake (kcal/day/meal) from ad-libitum high-fat dinner (primary endpoint), pre- and post-ingestive responses, and the hedonic evaluation of food, and its effect on food choice, cravings and feelings of control.
The secondary objectives are to determine the effect of rimonabant on body weight with or without hypocaloric diet and its clinical and laboratory safety.
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
- •Obese subjects with Body Mass Index ≥ 30 and < 45 kg/m²
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
排除标准
- 未提供
结局指标
主要结局
Absolute change from baseline in energy intake during ad-libitum dinner of the high-fat probe day at Weeks 3/4 of double-blind treatment.
次要结局
- Satiety, food choice, feeling of control, craving using a series of rating scales during the probe and/or "free-living" days
- Clinical Safety
研究者
研究点 (2)
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