NCT00972829Unknown4 期
Tolerability and Lipid Lowering Effect of Weekly/Biweekly Crestor in Statin Intolerant Patients Treated With Zetia
Bronx VA Medical Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Low-density lipoprotein (LDL) cholesterol
研究概览
简要总结
Recently, research studies have shown that patients who have had trouble taking statins every day, are able to take statins if they take them only once or twice a week. The investigators are doing a research study which involves switching people who are taking ezetimibe to the statin Crestor once or twice a week and to see how ell Crestor lowers cholesterol and if it is tolerated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
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
- •Patients with a history of intolerance to statins
- •Patients currently receiving ezetimibe
- •Patients willing and able to provide signed informed consent
排除标准
- •Patients receiving a statin (Lipitor, Crestor, Lescol, Simvastatin, or Pravachol)
- •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 < 40 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 cyclosporine within the last 3 months
- •Use of gemfibrozil within the last month
- •Patients unwilling or unable to provide informed consent
- •Patients with poor compliance
- •Women of childbearing potential
- •History of rhabdomyolysis due to statins
研究组 & 干预措施
Crestor
Experimental
Crestor 10 or 20 milligrams
干预措施: Rosuvastatin (Drug)
Ezetimibe
Active Comparator
Ezetimibe 5 or 10 milligrams
干预措施: Ezetimibe (Drug)
结局指标
主要结局
Low-density lipoprotein (LDL) cholesterol
时间窗: 3-4 months
次要结局
- The ability to remain on Crestor for the study period(12 months)
研究者
研究点 (1)
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