NCT00418171已完成4 期
An International, Multicenter, Large Simple Trial (LST) To Compare The Cardiovascular Safety Of Ziprasidone And Olanzapine
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 18,239
- 试验地点
- 6
- 主要终点
- The primary objective of the study is to estimate the relative incidence among users of ziprasidone and olanzapine of non-suicide mortality within 12 months.
研究概览
简要总结
The primary objective of the study is to estimate the relative incidence among users of ziprasidone and olanzapine of non-suicide mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients newly treated for schizophrenia and those receiving continuing treatment will be eligible if the treating psychiatrist is ready to initiate a new antipsychotic medication, and would consider using either ziprasidone or olanzapine as an appropriate therapy.
- •Male and female patients who meet all criteria listed below are eligible to be enrolled in this study:
- •Diagnosed with schizophrenia
- •Willing to provide information on at least one alternate contact person for study staff to contact regarding patient's whereabouts, should the patient be lost-to-follow-up over the course of the study
排除标准
- •Progressive fatal disease of a life expectancy which prohibits them from participating in a one year research study
- •Previously randomized to study medication and enrolled in this study
结局指标
主要结局
The primary objective of the study is to estimate the relative incidence among users of ziprasidone and olanzapine of non-suicide mortality within 12 months.
次要结局
- To estimate the relative incidence among users of ziprasidone and olanzapine of all-cause mortality, mortality due to suicide, cardiovascular mortality, mortality due to sudden death(During the year observation period)
- To estimate the relative incidence among users of ziprasidone and olanzapine of all-cause hospitalization, hospitalization for arrhythmia, myocardial infarction, or diabetic ketoacidosis(During the year observation period)
- The rate of discontinuation of randomized treatment.(During the year observation period)
研究者
研究点 (6)
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