跳至主要内容
临床试验/NCT00099216
NCT00099216已完成3 期

Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia

Novartis Pharmaceuticals63 个研究点 分布在 8 个国家目标入组 708 人开始时间: 2001年8月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
708
试验地点
63
主要终点
Change in cognition from baseline at week 24

研究概览

简要总结

The goal of this research study is to evaluate the effectiveness, tolerability and safety of rivastigmine capsules in males and females between the ages of 50 and 85 years old with probable vascular 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

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between the ages of 50 and 85 years old
  • Have contact with a responsible caregiver 3 or more days per week
  • Be male or a female who is surgically sterilized or one year post menopausal

排除标准

  • Current diagnosis of severe or unstable cardiovascular or other diseases
  • Current diagnosis of active, uncontrolled seizure disorder, Parkinson's disease or Alzheimer's disease

结局指标

主要结局

Change in cognition from baseline at week 24

Global clinical impression of change from baseline at week 24

次要结局

  • Change in activities of daily living from baseline at week 24
  • Change in behavioral symptoms from baseline at week 24
  • Change in clinical staging from baseline at week 24

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (63)

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