NCT00139594已完成4 期
A 52-week, Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 181
- 试验地点
- 4
- 主要终点
- Safety and tolerability of treatment with licarbazepine over 52 weeks.
研究概览
简要总结
This extension study is designed to assess the long-tem tolerability and safety of licarbazepine in patients who completed the 6-week double-blind study CLIC477D2303.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent provided prior to participation in the extension study
- •successful completion of study CLIC477D2303
- •cooperation and willingness to comply with all study requirements
排除标准
- •premature discontinuation from study CLIC477D2303
- •failure to comply with study CLIC477D2303
研究组 & 干预措施
licarbazepine
Experimental
干预措施: licarbazepine (Drug)
结局指标
主要结局
Safety and tolerability of treatment with licarbazepine over 52 weeks.
with respect to the rates of adverse events and serious adverse events, as well as changes in laboratory values, ECGs and vital signs.
次要结局
未报告次要终点
研究者
研究点 (4)
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