NCT00459173已完成3 期
Comparison of the Efficacy and Safety of 2 Oral Doses of Rimonabant, 5 mg/Day or 20 mg/Day, Versus Placebo, as an Aid to Maintenance of Smoking Cessation (1-Year Treatment, 1-Year Follow-up)
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
- 4,850
- 试验地点
- 3
- 主要终点
- Time to smoking relapse from the point of re-randomization (Week 10) through Week 32
研究概览
简要总结
The primary study objective is to evaluate the efficacy of 2 dose levels of rimonabant (5 mg and 20 mg) for the maintenance of abstinence from smoking.
Secondary objectives are to evaluate the effect of rimonabant on craving and weight, the clinical and biological safety of 2 doses of rimonabant rimonabant during a 12-month treatment period and to evaluate the pharmacokinetics of the drug.
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
- •Smokers smoking at least 10 cigarettes/day as a mean within the 2 months preceding the screening visit
- •Motivated to quit with a score greater than or equal to 6 on the ten-point Motivation Scale
排除标准
- •non tobacco cigarettes consumption
- •chronic use of marijuana
- •pregnancy, breastfeeding
- •any clinically significant disease that might interfere with the efficacy or safety evaluation of the study drug
- •Concomitant use of drugs as an aid to smoking cessation or that might induce weight change
结局指标
主要结局
Time to smoking relapse from the point of re-randomization (Week 10) through Week 32
Smoking relapse defined as: any 7 or more consecutive days of smoking (even a puff) or any 2 consecutive days of smoking 5 or more cigarettes per day
次要结局
- Efficacy: Time to smoking relapse from Week 10 to Week 52, craving, body weight change in abstainers, lipid parameters
- Safety data
研究者
研究点 (3)
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