A Randomised, Double-blind Trial to Compare the Efficacy of Rosuvastatin 5 and 10 mg to Atorvastatin 10 mg in the Treatment of High Risk Patients With Hypercholesterolemia Followed by an Open Label Treatment Period With Rosuvastatin Up-titrated to the Maximum Dose of 20 mg for Those Patients Who do Not Achieve Goal
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 934
- 试验地点
- 1
- 主要终点
- Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 5mg With Atorvastatin 10mg
研究概览
简要总结
This trial is to compare the efficacy, safety and tolerability of Rosuvastatin with Atorvastatin by assessing the change of LDL-C in patients with hypercholesterolemia and history of coronary heart disease (CHD) or risk equivalent, or a 10 year CHD risk of no less than 10%, following 6-week treatment and a possible 6 week extension treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Treated for or diagnosed hypercholesterolemia or have had a high risk with hypercholesterolemia
- •LDL-C between 3.36mmol/L and 6.5 mmol/L if not treated with statin or between 2.6mmol/L and 4.14 mmol/L
- •Fasting triglyceride less than 4.52mmol/L
排除标准
- •History of statin induced myopathy
- •Unstable or uncontrolled cardiovascular diseases
- •Familial dysbetalipoproteinemia
研究组 & 干预措施
1
Rosuvastatin 5mg qd
干预措施: Rosuvastatin (Drug)
2
Rosuvastatin 10mg qd
干预措施: Rosuvastatin (Drug)
3
Atorvastatin 10mg qd
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 5mg With Atorvastatin 10mg
时间窗: baseline, 6 weeks
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a two-sided significance level of 0.025 on ITT population.
Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 10mg With Atorvastatin 10mg
时间窗: baseline, 6 weeks
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.025 on ITT population.
次要结局
- Percentage Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 6(baseline, 6 weeks)
- Percentage Change From Baseline in Total Cholesterol (TC ) at Week 6(baseline, 6 weeks)
- Percentage Change From Baseline in Triglycerides (TG) at Week 6(baseline, 6 weeks)
- Percentage Change From Baseline in Non High Density Lipoprotein-Cholesterol (nonHDL-C) at Week 6(baseline, 6 weeks)
- Percentage Change From Baseline in Apolipoprotein B (ApoB) at Week 6(baseline, 6 weeks)
- Percentage Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 6(baseline, 6 weeks)
- Percentage Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (TC/HDL-C) at Week 6(baseline, 6 weeks)
- Percentage Change From Baseline in Low Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (LDL-C/HDL-C) at Week 6(baseline, 6 weeks)
- Percentage Change From Baseline in Non High Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (nonHDL-C/HDL-C) at Week 6(baseline, 6 weeks)
- Percentage Change From Baseline in Apolipoprotein B/Apolipoprotein A I (ApoB/ApoA-I) at Week 6(baseline, 6 weeks)
- Percentage of Patients Achieved ATP III Guideline (2001) Low Density Lipoprotein Cholesterol (LDL-C) Goal at Week 6(week 6)
- 6 weeksPercentage of Patients Achieved ATP III Guideline (2001) Non High Density Lipoprotein-Cholesterol (nonHDL-C) Goal at Week 6(week 6)
- Percentage of Patients Achieved National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Guideline (2001) Low Density Lipoprotein-Cholesterol (LDL-C) Goal After Titration(from week 6 to week 12)