NCT00654394已完成3 期
Randomized, Double-Blind, Multicenter, Trial to Assess the Effect of High & Low Doses of ZD4522 on Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects With Asymptomatic Carotid Stenosis After 24 Months of Dosing.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 200
- 主要终点
- Changes in carotid wall volume as measured by MRI scan
研究概览
简要总结
The purpose of this study is to examine the changes in the carotid artery when subjects receive high or low doses of rosuvastatin.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fasting blood low density lipoprotein cholesterol level as defined by the protocol
- •Diagnosed carotid arterial stenosis
排除标准
- •The use of lipid lowering drugs or dietary supplements after Visit
- •Heavy or total occlusion of the carotid artery or recent stroke
- •Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse
研究组 & 干预措施
1
Experimental
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Changes in carotid wall volume as measured by MRI scan
时间窗: At 40 weeks and 104 weeks
次要结局
- Safety: adverse events & abnormal laboratory markers(2 weekly for first 4 weeks then 4 weekly)
- Other changes in the structure and composition of the carotid arterial wall as defined in the protocol.(At 40 weeks and 104 weeks)
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