NCT00464165已完成3 期
Comparison of the Efficacy and Safety of 2 Oral Doses of Rimonabant, 5mg/Day or 20mg/Day, Versus Placebo, as an Aid to Smoking Cessation; Multiple Country, Randomized, Double-blind, 3-arm, 10-week Treatment, 40-week 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
- 789
- 试验地点
- 7
- 主要终点
- Prolonged abstinence from smoking during the last 4 weeks of treatment reported by the subject and confirmed by exhaled carbon monoxide (CO) and cotinine measurements
研究概览
简要总结
The primary objective is to assess the efficacy of 2 fixed doses of rimonabant versus placebo on abstinence from tobacco use in cigarette smokers.
The secondary objective is to evaluate the effects of rimonabant on craving and weight and on the clinical and biological safety and tolerability of rimonabant in a population of cigarette tobacco smokers during a 10-week treatment period and to observe the percentage of abstinent subjects during a 40-week follow-up post treatment.
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
Prolonged abstinence from smoking during the last 4 weeks of treatment reported by the subject and confirmed by exhaled carbon monoxide (CO) and cotinine measurements
次要结局
- Efficacy: mean change of the total score of Questionnaire on Smoking Urges (QSU) brief scale, categorical change in body weight in subjects with Body Mass Index lower than 30 kg/m² at baseline who achieve prolonged abstinence
- Safety data
研究者
研究点 (7)
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