NCT00276484已完成3 期
A Multicenter, Rand., Double-Blind, Titration Study to Evaluate & Compare the Efficacy & Safety of Ezetimibe Plus Atorvastatin Vs Atorvastatin in Hypercholesterolemic Pts. at High Risk for CHD Not Adequately Controlled on Atorvastatin 40 Mg
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 579
- 主要终点
- Percent Change From Baseline to Week 6 in Low-Density Lipoprotein (LDL)-C
研究概览
简要总结
To Evaluate and Compare the Efficacy and Safety of Ezetimibe Plus Atorvastatin Versus Atorvastatin in Hypercholesterolemic Patients at High Risk for Coronary Heart Disease Not Adequately Controlled on Atorvastatin 40 mg.
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
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with LDL-C >70 mg/dL & on a stable dose of atorvastatin 40 mg
排除标准
- •Pregnant or lactating women or intending to become pregnant
- •Patient with sensitivity or intolerance to ezetimibe or atorvastatin
研究组 & 干预措施
1
Active Comparator
Atorvastatin 80 mg
干预措施: atorvastatin (Drug)
2
Experimental
Atorvastatin 40 mg + ezetimibe 10 mg
干预措施: atorvastatin (Drug)
2
Experimental
Atorvastatin 40 mg + ezetimibe 10 mg
干预措施: ezetimibe (Drug)
结局指标
主要结局
Percent Change From Baseline to Week 6 in Low-Density Lipoprotein (LDL)-C
时间窗: Baseline and 6 weeks
Percent Change in LDL-C = \[(week 6 value - baseline value)/baseline value\]\*100%
次要结局
- Percent Change From Baseline to Week 6 in Triglycerides (TG)(Baseline and 6 Weeks)
- Number of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6(6 Weeks)
- Percent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C)(Baseline and 6 weeks)
- Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)(Baseline and 6 Weeks)
- Percent Change From Baseline to Week 6 in Total-Cholesterol(Baseline and 6 Weeks)
- Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B)(Baseline and 6 Weeks)
- Percent Change From Baseline to Week 6 in Low-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (LDL-C:HDL-C) Ratio(Baseline and 6 Weeks)
- Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I)(Baseline and 6 Weeks)
- Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio(Baseline and 6 Weeks)
- Percent Change From Baseline to Week 6 in Total-Cholesterol (TC):High-Density Lipoprotein Cholesterol (HDL-C) Ratio(Baseline and 6 Weeks)
- Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (Non-HDL-C:HDL-C) Ratio(Baseline and 6 Weeks)
- Percent Change From Baseline to Week 6 in C Reactive Protein (CRP)(Baseline and 6 Weeks)
研究者
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