NCT00095719已完成3 期
A Safety & Tolerability Study of Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia
Otsuka Pharmaceutical Development & Commercialization, Inc.1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2003年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- tolerability
研究概览
简要总结
The purpose of this trial is to test the safety & tolerability of intramuscular aripiprazole in acutely agitated patients diagnosed with Dementia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute agitation in Patients with a DSM-IV diagnosis of Alzheimer's, vascular or mixed Dementia.
排除标准
- •Current DSM-IV Axis 1 diagnosis other than Alzheimer's, vascular or mixed Dementia.
研究组 & 干预措施
A1
Active Comparator
干预措施: Aripiprazole (Drug)
B1
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
tolerability
次要结局
- safety assessments
研究者
研究点 (1)
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