An Open-label Extension to Study 49653/461, to Assess the Long-term Safety of Rosiglitazone (Extended Release Tablets) in Subjects With Mild to Moderate Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AE's)
研究概览
简要总结
This is an open-label extension to study 49653/461, to assess the long-term safety of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's Disease.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
rosiglitazone
Extended Release Tablets
干预措施: rosiglitazone (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AE's)
时间窗: From start of study medication (Wk 0) to Wk 50
An AE was defined as any untoward medical occurrence or clinical investigation in a participant, temporally associated with the use of a medicinal product, whether or not, considered related to the medicinal product. For marketed medicinal products, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. The number of participants with all AEs, drug related AEs, serious adverse events (SAEs), AE leading to permanent (prm) discontinuation (disc) of study drug or withdrawal were reported.
次要结局
- Mean Change From Baseline in Mini Mental State Examination (MMSE) Total Score(From baseline to Wk 48)
- Mean Change From Baseline in Vital Signs-heart Rate (HR)(Baseline (Wk 0) to Wk 50)
- Number of Participants With Vital Signs of Clinical Concern.(Up to Wk 50)
- Mean Change From Baseline in Vital Signs- Weight(Baseline (Wk 0) to Wk 50)
- Number of Participants With Clinical Chemistry Parameters of Clinical Concern(Up to Wk 50)
- Number of Participants With Clinical Chemistry Parameters of Clinical Concern-lipids(Up to Wk 50)
- Number of Participant's With Hematology Parameters of Clinical Concern(Up to Wk 50)
- Mean Change From Baseline in Vital Signs- Systolic and Diastolic Blood Pressure(Baseline (Wk 0) to Wk 50)
- Number of Participants With SAEs(From start of study medication (Wk 0) to Wk 50)
- Number of Participants With AE of Peripheral Edema by Grade(Up to Wk 50)