NCT00409773已完成3 期
A Multicenter, Randomized, Double-Blind, Parallel Arm, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Versus Atorvastatin in Patients With Metabolic Syndrome and Hypercholesterolemia at High Risk for Coronary Heart Disease
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,143
- 主要终点
- Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6
研究概览
简要总结
A 6-week clinical trial in patients with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease to study the effects of ezetimibe/simvastatin and atorvastatin on lipids.
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
- •Patients 18 to 79 years of age with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease (CHD) with LDL-C above 70 mg/dL or 100 mg/dL depending on their CHD risk category
排除标准
- •A condition which, in the opinion of the investigator, pose a risk to the patient or interfere with participating in the study
- •Patient is likely to be greater than 20% noncompliant in taking study medications
- •Patients with chronic medical conditions
- •Patients with unstable doses of medications
- •Pregnant or lactating women, women intending to become pregnant
- •Patient is currently receiving prescription therapy with statins or other lipid-altering medications
- •Patient with Type 1 or Type 2 diabetes mellitus that is poorly controlled, newly diagnosed, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin)
研究组 & 干预措施
1
Other
Arm 1: drug + comparator + Placebo
干预措施: ezetimibe (+) simvastatin (Drug)
2
Other
Arm 2: drug + comparator + Placebo
干预措施: ezetimibe (+) simvastatin (Drug)
3
Other
Arm 3: drug + comparator + Placebo
干预措施: ezetimibe (+) simvastatin (Drug)
4
Other
Arm 4: drug + comparator + Placebo
干预措施: ezetimibe (+) simvastatin (Drug)
5
Other
Arm 5: drug + comparator + Placebo
干预措施: ezetimibe (+) simvastatin (Drug)
结局指标
主要结局
Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6
时间窗: Baseline and 6 Weeks
次要结局
- Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6(Baseline and 6 Weeks)
- Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6(Baseline and 6 Weeks)
- Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6(Baseline and 6 Weeks)
- Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6(Baseline and 6 Weeks)
- Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6(Baseline and 6 Weeks)
- Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6(Baseline and 6 Weeks)
- Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6(Baseline and 6 Weeks)
- Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6(Baseline and 6 Weeks)
- Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6(Baseline and 6 Weeks)
- Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6(Baseline and 6 weeks)
- Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6(Baseline and 6 Weeks)
- Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD)(Baseline and 6 Weeks)
- Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD)(Baseline and 6 Weeks)
- Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6(Baseline and 6 Weeks)
研究者
相似试验
已完成
3 期
Lipid Efficacy and Safety in Participants With Mixed Hyperlipidemia (MK-0524B-024)Mixed HyperlipidemiaNCT00289900Merck Sharp & Dohme LLC2,340
已完成
3 期
Lipid Efficacy/Tolerability Study (0524A-020)Primary HypercholesterolaemiaMixed HyperlipidaemiaNCT00269204Merck Sharp & Dohme LLC1,620
已完成
3 期
Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)Primary HypercholesterolemiaMixed DyslipidemiaNCT00479388Merck Sharp & Dohme LLC1,216
终止
2 期
MK0767 in Metabolic Syndrome-Dyslipidemia (0767-016)Metabolic X Syndrome DyslipidemiaNCT00703690Merck Sharp & Dohme LLC436
已完成
3 期
Lipid Efficacy Study (0524B-022)(COMPLETED)Primary HypercholesterolemiaMixed HyperlipidemiaNCT00269217Merck Sharp & Dohme LLC1,400