An Open Label Extension To The B1451027 Protocol To Evaluate The Long Term Safety And Tolerability Of Dimebon (PF 01913539) In Patients With Alzheimer's Disease
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 649
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety and tolerability of Dimebon in patients with Alzheimer's disease.
详细描述
This study was terminated on May 7, 2010 as part of modification of the dimebon development plan following lack of demonstration of efficacy in the completed DIM14 (CONNECTION) Study. The study was not terminated due to any safety findings. Dimebon has been well -tolerated in clinical trials. Demonstration of efficacy for dimebon in Alzheimer's disease is pending completion of the ongoing DIM18 (CONCERT) Study.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of previous Phase 3 Dimebon study (B1451027).
排除标准
- •Have any severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
研究组 & 干预措施
Dimebon 20 mg TID
10 mg TID for Week 1, followed by 20 mg TID for remainder of study
干预措施: Dimebon (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events (AEs)
时间窗: Baseline up to Week 65 (end of treatment)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
次要结局
- Percentage of Participants With Abnormal Clinically Significant Vital Signs(Baseline up to Week 65 (end of treatment))
- Percentage of Participants With Abnormal Clinically Significant Laboratory Values(Baseline up to Week 65 (end of treatment))
- Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings(Baseline up to Week 65 (end of treatment))