jRCT2080222754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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- 24-week Treatment Period: Open-label, Uncontrolled 4-week Run-out Period: Double-blind, Placebo-controlled
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients who have completed Study 339-14-
- •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 3 or 4 heart failure or angina pectoris, renal function disorder with estimated glomerular filtration rate (eGFR) of under 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.
结局指标
主要结局
-
safety Adverse Events, Laboratory Parameters and Vital Signs
次要结局
未报告次要终点
研究者
研究点 (1)
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