NCT00762164已完成4 期
Comparative Efficacy of a Vytorin 10/80 Tablet Split Into 4 (Estimated Dose Ezetimibe 2.5 + Simvastatin 20) Versus Simvastatin 20 Milligrams on LDL Cholesterol
Bronx VA Medical Center1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2007年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- LDL Cholesterol
研究概览
简要总结
The purpose of this study is to compare the efficacy of a Vytorin 10/80 tablet, an approved agent for the treatment of elevated LDL cholesterol which combines the cholesterol absorption inhibitor Ezetimibe 10 mg and simvastatin 80 mg, when split into 4 using a tablet splitter, versus a whole simvastatin 20 milligram tablet.
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
- 是
入选标准
- •Subjects with an LDL-cholesterol greater than 100 mg/dL
- •Patients willing and able to provide signed informed consent
排除标准
- •Patients receiving a statin (Lipitor, Crestor, Lescol, Simvastatin, or Pravachol)
- •Patients intolerant of statins
- •Patients receiving ezetimibe
- •Patients intolerant of ezetimibe
- •Patients receiving a niacin preparation
- •Stroke, TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within 3 months
- •Cancer undergoing active treatment
- •Creatinine clearance < 50 ml/minute
- •Active liver disease or persistent elevation of SGOT or SGPT > 2 times the upper limit of normal level
- •Participation in any clinical study within the last 30 days
- •Drug addition or alcohol abuse within the past 6 months
- •Use of azole antifungal agents, amiodarone, fibrates or immunosuppressant drugs within the last 3 months
- •Active use of macrolide antibiotics or verapamil
- •Consumption of grapefruit juice on a daily basis
- •Patients unwilling or unable to provide informed consent
- •Patients with poor compliance
- •Women of childbearing potential
研究组 & 干预措施
1Vytorin 10/80 divided into 4
Active Comparator
Vytorin 10/80 divided into 4
干预措施: Vytorin (Drug)
Simvastatin
Active Comparator
Simvastatin 20 milligrams
干预措施: Simvastatin (Drug)
结局指标
主要结局
LDL Cholesterol
时间窗: 6 weeks
次要结局
- Total Cholesterol(6 weeks)
研究者
Lawrence Baruch
Staff Physician
Bronx VA Medical Center
研究点 (1)
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