NCT00188812已完成3 期
Open-Label, Multicentre, One Year Extension of the Evaluation of the Safety of Donepezil Hcl in Patients With Dementia Associated With Cerebrovascular Disease
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- safety assessments
研究概览
简要总结
one year extension study following a previous double-blind study to evaluate safety of the drug
详细描述
A one year extension study for patients who completed E2020-A001-319. Patients will receive 5my donepezil daily for the first 8 weeks and will be assessed by the incidence of advere events, changes in physical exams, ECG and clinical lab determinations. The results will be assessed 6 timues during the year. After 8 week, the investigator may increase the dose to 10mg/day if the patient if the patients show satisfactory tolerability. Six psychometric scales will also be evaluatd.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •must have completed previous study E2020-A001-319
排除标准
- •absence of a reliable caregiver
- •clinically significant medical condition
- •recent TIA
结局指标
主要结局
safety assessments
次要结局
未报告次要终点
研究者
研究点 (2)
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