A 12-Week, Multicenter, Double-blind, Randomized, Placebo-controlled Parallel-group Phase 2 Dose Selection Study of Lorcaserin Hydrochloride, an Oral 5-HT2C Receptor Agonist for Smoking Cessation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 603
- 试验地点
- 23
- 主要终点
- Percentage of Participants With Abstinence for the Last 4 Weeks of Treatment From Weeks 9-12
研究概览
简要总结
In smokers who are motivated to stop smoking, treatment with lorcaserin compared with placebo will provide greater abstinence as measured by the last 4 weeks of treatment (Weeks 9-12). The target quit date was Day 15.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 18-65 years, inclusive
- •≥10 cigarettes per day with no period of abstinence longer than 3 months in the past year and who are motivated to quit smoking
- •Able to give signed informed consent
- •Eligible female patients will be:
- •non-pregnant
- •non-lactating
- •agree to use an acceptable method of effective contraception during the study
- •Eligible male patients agree to use contraception when sexually active with a female partner who is not using an acceptable method of birth control
- •Body weight of ≥50 kg (110 pounds), inclusive
- •Considered to be in stable health in the opinion of the investigator
排除标准
- •Patients who meet any of the following criteria will be excluded from the study.
- •Prior or current use of lorcaserin HCl
- •Prior participation in any study of a nicotine vaccination
- •Use of other therapies for smoking cessation is not allowed within 3 months of screening through study exit
- •Use of tobacco products other than cigarettes
- •Prior use of fenfluramine or dexfenfluramine
- •Serious or unstable medical condition or clinically significant new illness within the 6 months prior to screening
- •Previous participation in any clinical study within 6 weeks prior to the screening visit
- •History of severe allergies, severe drug or excipient allergy or hypersensitivity
- •History of significant cardiovascular condition
- •History of other significant medical conditions
- •Significant risk of suicide
- •Anticipated use of any agents that are associated with valvulopathy and/or pulmonary hypertension
- •Positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- •Recent history of alcohol or drug/solvent abuse
- •Concurrent participation in the study by more than one member of the same household
- •Not suitable to participate in the study in the opinion of the investigator
研究组 & 干预措施
APD356 10 mg b.i.d.
APD356 - lorcaserin hydrochloride 10 mg tablet administered twice daily for 12 weeks
干预措施: APD356-lorcaserin hydrochloride (Drug)
APD356 10 mg q.d.
APD356 - lorcaserin hydrochloride 10 mg tablet administered once daily and one matching placebo tablet administered once daily for 12 weeks
干预措施: APD356-lorcaserin hydrochloride (Drug)
Placebo 10 mg b.i.d
Placebo tablet matching the APD356-lorcaserin hydrochloride 10 mg tablet administered twice daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Abstinence for the Last 4 Weeks of Treatment From Weeks 9-12
时间窗: Week 9 - Week 12
Primary efficacy was assessed as the CO (carbon monoxide)-confirmed continuous abstinence rate for the last 4 weeks of treatment (Month 3: Weeks 9 through 12), defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels \<= 10 ppm.
次要结局
- Abstinence During Weeks 3-12(Week 3 to Week 12)
- The 7 Day Point Prevalence or Weekly Abstinence at Week 8(Week 8)
- The 7 Day Point Prevalence or Weekly Abstinence at Week 12(Week 12)
- Body Weight(Baseline to Week 12)