NCT01587235撤回4 期
A Multicenter, Open-label, 6 Week Study to Evaluate the Efficacy and Safety of Algorithm Based Intensive Treatment With Vytorin Versus Standard Treatment of Other Statins in Moderate, Moderately High and High Risk Patients.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Number of Participants who Achieve Low-density Lipoprotein Cholesterol (LDL-C) goal (High-risk <100 mg/dL; Moderate-high and High risk <130 mg/dL)
研究概览
简要总结
This study will evaluate and compare the effectiveness of MK-0653 (Vytorin) to current standard treatment with other statins for the treatment of dyslipidemia in moderate, moderately-high and high-risk participants.
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
- None
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
- •Low-density lipoprotein cholesterol (LDL-C) ≥100 mg/dL
- •Either treatment naïve (no previous treatment with lipid-lowering medication) or if previously treated with lipid-lowering medication, must complete a wash-out 6 weeks prior to enrollment
排除标准
- •LDL-C level ≥ 190 mg/dL
- •Hypersensitivity or intolerance to Vytorin, ezetimibe or simvastatin
- •Taking other lipid lowering agent except statins. (i.e. fenofibrate, niacin, ezetimibe, etc)
- •Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study
- •Currently participating in or has previously participated in a study within 30 days
- •Congestive heart failure defined by New York Heart Association (NYHA) Class III or IV within previous 6 months
- •Uncontrolled cardiac arrhythmias or recent significant electrocardiogram (ECG) changes
- •Unstable angina pectoris
- •Myocardial infarction, coronary artery bypass surgery, or angioplasty within previous 3 months
- •Unstable or severe peripheral artery disease within previous 3 months
- •Uncontrolled hypertension (treated or untreated)
- •Type 1 or Type 2 diabetes mellitus that is poorly controlled or recently diagnosed (within previous 3 months)
- •Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
- •Serious cerebrovascular disorder (ischemic stroke or cerebral hemorrhage) within the previous 6 months
- •Received treatment with systemic corticosteroids, any cyclical hormones
- •within previous 8 weeks
研究组 & 干预措施
Vytorin
Experimental
干预措施: Ezetimibe/simvastatin (Drug)
Other Statin
Active Comparator
干预措施: Other Statin (Drug)
结局指标
主要结局
Number of Participants who Achieve Low-density Lipoprotein Cholesterol (LDL-C) goal (High-risk <100 mg/dL; Moderate-high and High risk <130 mg/dL)
时间窗: Week 6
次要结局
- Change in LDL-C level From Baseline(Baseline and Week 6)
- Number of High-risk Participants who Achieve an LDL-C < 70 mg/dL(Week 6)
- Change in Serum LDL From Baseline(Baseline and Week 6)
- Change in Total Cholesterol From Baseline(Baseline and Week 6)
- Change in High-density lipoprotein (HDL) From Baseline(Baseline and Week 6)
- Change in Serum Triglycerides (TG) From Baseline(Baseline and Week 6)
- Change in Serum Non-HDL From Baseline(Baseline and Week 6)
- Change in LDL-C/HDL-C Ratio From Baseline(Baseline and Week 6)
- Change in Apolipoprotein B (ApoB) From Baseline(Baseline and Week 6)
- Number of Participants who Achieve non-HDL-C goal (High-risk <100 mg/dL; Moderate-high and High risk <160 mg/dL))(Week 6)
研究者
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