JPRN-jRCT2080224118已完成3 期
A multicenter, uncontrolled, open-label trial to evaluate the safety of extended treatment with brexpiprazole (OPC-34712) in patients with agitation associated with dementia of the Alzheimer's type
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 164
研究概览
简要总结
Brexpiprazole administered at doses of 1 mg and 2 mg once daily for 14 weeks in patients with agitation associated with dementia of the Alzheimer`s type who completed the 10-week treatment period of Trial 331-102-00088 provided sustained therapeutic effect and was well tolerated with no outcomes suggestive of a significant impact on safety.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 55age old 至 <= 89age old（—）
- 性别
- All
入选标准
- •1. Patients who completed the double-blind treatment period for 10 weeks and all observation, examination and evaluation at Week 10 of the double-blind trial.
- •2. Patients whose caregiver can properly collect the necessary information.
排除标准
- •1. Patients who had a serious adverse event which the principal investigator or sub-investigator assessed as related to the investigator product during the double-blind trial.
- •2. Patients who had delirium during the double-blind trial.
研究者
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