A 52-week, Open Label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine 750 - 2000 mg/d in the Treatment of Manic Episodes of Bipolar I Disorder.

Novartis0 个研究点目标入组 251 人开始时间: 2005年1月1日最近更新: 2017年3月28日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Novartis
入组人数: 251
主要终点: Safety and tolerability of licarbazepine with respect to adverse events, serious adverse events, changes in laboratory values, ECGs and vital signs.

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This extension study is designed to investigate the long-term safety and tolerability of licarbazepine 750-2000 mg/d over 52 weeks in patients who completed the 6-week double-blind study CLIC477D2302.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Diagnostic
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 the study CLIC477D2302
•willingness and ability to comply with all study requirements

排除标准

•premature discontinuation from the study CLIC477D2302
•failure to comply with the study CLIC477D2302 protocol

结局指标

主要结局

Safety and tolerability of licarbazepine with respect to adverse events, serious adverse events, changes in laboratory values, ECGs and vital signs.

次要结局

未报告次要终点

研究者

发起方

Novartis

申办方类型

Industry

责任方

Sponsor

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