A Multicenter, Randomized, Double-Blind, Parallel, 12-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet Versus Atorvastatin in Elderly Patients With Hypercholesterolemia at High or Moderately High Risk for Coronary Heart Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,289
- 主要终点
- Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12
研究概览
简要总结
A multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus atorvastatin in elderly patients with high cholesterol at high or moderately high risk for coronary heart disease.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has a cholesterol level of 130 mg/dL or greater
- •Patient is willing to maintain a cholesterol lowering diet for as long as they are in the study
- •Patient is at moderate high risk or high risk for coronary heart disease per the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) guidelines
排除标准
- •Patient weighs less than 100 lbs
- •Patient has an allergy to ezetimibe, simvastatin or atorvastatin
研究组 & 干预措施
1
Each patient will receive 1 active treatment dose & 2 Placebo (Pbo) doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.
干预措施: Atorvastatin 10 mg (Drug)
2
Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.
干预措施: Ezetimibe 10 mg/simvastatin 20 mg (Drug)
3
Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.
干预措施: Atorvastatin 20 mg (Drug)
4
Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.
干预措施: Ezetimibe 10 mg/simvastatin 40 mg (Drug)
5
Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.
干预措施: Atorvastatin 40 mg (Drug)
结局指标
主要结局
Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12
时间窗: Baseline and 12 weeks
次要结局
- Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12(12 weeks)
- Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12(12 Weeks)
- Percentage of Patients Without Atherosclerosis Vascular Disease (AVD) Who Achieved LDL-C <100 mg/dL or Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12(12 Weeks)
- Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12(12 Weeks)
- Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12(12 Weeks)