NCT00170768已完成2 期
Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 3.
研究概览
简要总结
The purpose of this study is to explore the possible cognitive effects of darifenacin modified release and long-acting oxybutynin.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 60 and over
- •United States English as a primary language
- •Given written informed consent by signing and dating an informed consent form prior to study entry
排除标准
- •Current diseases in which the use of anti-cholinergic drugs is contraindicated, including the use of drugs with anti-cholinergic effects
- •Volunteers with history of urinary retention or current bladder outlet obstruction, as determined by the investigator
- •Other protocol defined inclusion/exclusion criteria may apply.
- •Current use of drugs known to effect memory and cognition Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
1
Experimental
Darifenacin
干预措施: Darifenacin (Drug)
2
Active Comparator
Oxybutynin
干预措施: Oxybutynin (Drug)
3
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 3.
次要结局
- Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 1 & 2.
- Effects on other cognitive domains measured by various tests at week 1,2 and 3.
研究者
研究点 (1)
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