A Multicenter., Rand., Double-Blind, Titration Study to Evaluate & Compare the Efficacy & Safety of Ezetimibe Plus Atorvastatin Vs Atorvastatin in Hypercholesterolemic Pts. at Moderately High Risk for CHD Not Adequately Controlled on Atorvastatin 20 Mg
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 196
- 主要终点
- Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6
研究概览
简要总结
The purpose of this study is to evaluate and compare the efficacy and safety of ezetimibe plus atorvastatin versus atorvastatin in hypercholesterolemic patients at moderately high risk for coronary heart disease not adequately controlled on atorvastatin 20 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 >100 mg/dL & on a stable dose of atorvastatin 20 mg
排除标准
- •Pregnant or lactating women or intending to become pregnant
- •Patient with sensitivity or intolerance to ezetimibe or atorvastatin
- •Patient with diabetes or coronary heart disease
研究组 & 干预措施
1
Atorvastatin 40mg tablet + Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day).
干预措施: Comparator: Placebo (Drug)
2
Atorvastatin 40mg Pbo tablet + Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day).
干预措施: Comparator: Placebo. (Drug)
2
Atorvastatin 40mg Pbo tablet + Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day).
干预措施: Comparator: ezetimibe (Drug)
1
Atorvastatin 40mg tablet + Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day).
干预措施: Comparator: atorvastatin (Drug)
结局指标
主要结局
Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6
时间窗: 6 weeks
\[(6 week value - baseline value)/baseline value\]\*100%.
次要结局
- Percent Change in High Density Lipoprotein -Cholesterol (HDL-C)at Week 6(6 weeks)
- Percent Change From Baseline in Total-Cholesterol:High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6(6 Weeks)
- Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6(6 Weeks)
- Number of Participants Who Attained Target LDL-C <100 mg/dL at Week 6(6 weeks)
- Percent Change From Baseline in Apolipoprotein B: Apolipoprotein A-I Ratio at Week 6(6 Weeks)
- Percent Change From Baseline in Total-Cholesterol at Week 6(6 Weeks)
- Percent Change From Baseline in Apolipoprotein B at Week 6(6 Weeks)
- Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6(6 Weeks)
- Percent Change From Baseline in Triglycerides (TG) at Week 6(6 weeks)
- Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (HDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6(6 Weeks)
- Percent Change From Baseline in C-Reactive Protein (CRP) at Week 6(6 Weeks)