NCT02251847Unknown3 期
The Efficacy and Safety of a Combination Therapy of Rosuvastatin and Ezetimibe Versus Monotherapy of Rosuvastatin in Hypercholesterolemia Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Percent change from baseline to 8 week in LDL-Cholesterol
研究概览
简要总结
To evaluate efficacy and safety of a combination therapy of rosuvastatin and ezetimibe versus monotherapy of rosuvastatin in hypercholesterolemia patients
详细描述
To evaluate efficacy and safety of a combination therapy of rosuvastatin and ezetimibe versus monotherapy of rosuvastatin in hypercholesterolemia patients
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 (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypercholesterolemic patient
排除标准
- •Has history of hypersensitivity to HMG-CoA reductase inhibitor and Ezetimibe
研究组 & 干预措施
R5
Active Comparator
Rosuvastatin 5mg
干预措施: Rosuvastatin/Ezetimibe (Drug)
R10
Active Comparator
Rosuvastatin 10mg
干预措施: Rosuvastatin/Ezetimibe (Drug)
R20
Active Comparator
Rosuvastatin 20mg
干预措施: Rosuvastatin/Ezetimibe (Drug)
R5/E10
Experimental
Rosuvastatin 5mg/ezetimibe 10mg
干预措施: Rosuvastatin/Ezetimibe (Drug)
R10/E10
Experimental
Rosuvastatin 10mg/ezetimibe 10mg
干预措施: Rosuvastatin/Ezetimibe (Drug)
R20/E10
Experimental
Rosuvastatin 20mg/ezetimibe 10mg
干预措施: Rosuvastatin/Ezetimibe (Drug)
结局指标
主要结局
Percent change from baseline to 8 week in LDL-Cholesterol
时间窗: baseline and 8 week
次要结局
- Percent change from baseline to 4 week in LDL-Cholesterol(baseline and 4 week)
研究者
研究点 (1)
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