NCT00653445已完成3 期
A 6wk Open-Label, Randomised, Multicentre, Phase IIIb, Parallel Group Study to Compare the Safety & Efficacy of Rosuvastatin 40mg in Comb.With Ezetimibe 10mg in Subjects With Hypercholesterolaemia & CHD or Atherosclerosis or a CHD Risk Equiv. (10 yr Risk Score >20%).
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
- 主要终点
- To compare the efficacy of rosuvastatin alone with rosuvastatin combined with ezetimibe by measuring fasting low-density lipoprotein cholesterol (LDL-C) levels at baseline and Week 6
研究概览
简要总结
The purpose of this study is to compare 6 weeks of treatment with rosuvastatin alone compared with 6 weeks of treatment of rosuvastatin combined with ezetimibe in achieving low density lipoprotein level goals.
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
- None
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
- •A history of CHD or clinical evidence of atherosclerosis or multiple risk factors that confer a high risk as defined in the protocol.
- •Fasting LDL-C concentrations at Visit 1 as defined in the protocol.
- •Discontinuation of all lipid lowering therapy at Visit 1.
排除标准
- •History of statin induced serious side effects, or serious hypersensitivity reaction to other statins.
- •Subjects considered to be unstable by the investigator after the following events: a myocardial infarction (heart attack), unstable angina, myocardial revascularisation or another revascularisation procedure or a transient ischaemic attack (TIA) or stroke.
- •Severe congestive cardiac failure (as defined by the protocol - Appendix I).
- •Subjects awaiting a planned myocardial revascularisation prior to starting the study (i.e. planned prior to visit 1)..
研究组 & 干预措施
1
Experimental
Rosuvastatin 40mg/Ezetimibe 10mg combination therapy
干预措施: Rosuvastatin (Drug)
1
Experimental
Rosuvastatin 40mg/Ezetimibe 10mg combination therapy
干预措施: Ezetimibe (Drug)
2
Experimental
Rosuvastatin 40 mg
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
To compare the efficacy of rosuvastatin alone with rosuvastatin combined with ezetimibe by measuring fasting low-density lipoprotein cholesterol (LDL-C) levels at baseline and Week 6
次要结局
- To compare the efficacy of rosuvastatin alone with rosuvastatin combined with ezetimibe by measuring fasting blood lipid levels levels at baseline and Week 6
- Safety: by measuring adverse events & abnormal laboratory markers to compare safety & tolerability of rosuvastatin alone with rosuvastatin combined with ezetimibe
研究者
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