NCT02382276已完成3 期
A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 405
- 试验地点
- 7
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The long-term safety and efficacy of nalmefene hydrochloride at 20 mg in patients with alcohol dependence will be evaluated in a multicenter, open-label, uncontrolled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have completed Study 339-14-001
- •Patients who have signed the informed consent form for Study 339-14-002
排除标准
- •The patient has a clinically significant unstable illness (eg, complication of New York Heart Association (NYHA) class III or IV heart failure or angina pectoris, renal function disorder with estimated glomerular filtration rate (eGFR) of < 30 mL/min/1.73 m2, hepatic failure, and neoplastic disorder)
- •The patient has a clinically significant abnormal electrocardiogram (ECG) which is inappropriate for the participation in the trial in the opinion of the investigator or subinvestigator
研究组 & 干预措施
Nalmefene hydrochloride 20 mg
Experimental
As-needed; tablets, orally
干预措施: Nalmefene hydrochloride (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 24-week treatment period
次要结局
- Change in the Number of Heavy Drinking Days (HDDs) From Baseline(Week 24)
- Change in Total Alcohol Consumption (TAC) From Baseline(Week 24)
研究者
研究点 (7)
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