临床试验/NCT00228059

NCT00228059已完成3 期

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

Novartis1 个研究点分布在 1 个国家目标入组 132 人开始时间: 2005年1月1日最近更新: 2017年2月23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: 132
试验地点: 1
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研究点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/day over 52 weeks in patients who completed the 3-week double-blind study CLIC477D2301.

详细描述

A 52-week, open-label extension study to evaluate the safety and tolerability of licarbazepine 750- 2000 mg/day in the treatment of manic episodes of bipolar I disorder

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: 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 CLIC477D2301
•willingness and ability to comply with all study requirements

排除标准

•premature discontinuation from study CLIC477D2301
•failure to comply with the study CLIC477D2301 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

研究点 (1)

Loading locations...

相似试验

已完成

3 期

An 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 DisorderBipolar I Disorder

NCT00238485Novartis251

已完成

4 期

Open Label Extension Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar I DisorderBipolar Disorder

NCT00139594Novartis181

已完成

3 期

Long-term Safety and Efficacy of Lebrikizumab in Adult and Adolescent Participant With Moderate-to-Severe Atopic DermatitisAtopic Dermatitis

NCT05916365Almirall, S.A.174

已完成

3 期

Safety and Tolerability of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)Bipolar Disorder

NCT00265330Pfizer's Upjohn has merged with Mylan to form Viatris Inc.169

终止

3 期

Safety And Tolerability Of Ziprasidone In Adolescents With SchizophreniaSchizophrenia

NCT00265382Pfizer's Upjohn has merged with Mylan to form Viatris Inc.221