NCT00762229已完成不适用
Prospective Evaluation of LDL Levels in Patients Converted From Zetia (Ezetimibe)10 mg to 5 mg
Bronx VA Medical Center1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2007年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 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 effect on LDL cholesterol levels of converting patients who are receiving the cholesterol absorption inhibitor Zetia at a dose of 10 milligrams to 5 milligrams, when prescribed as a split 10 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
- Health Services Research
- 盲法
- None
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
- •Subjects receiving ezetimibe 10 mg
- •Subjects who have demonstrated compliance with ezetimibe as evidenced by the following Proportions of Days Covered patterns (which represent a PDC of more than 75%):
- •90 day prescriptions: Filled a ezetimibe prescription within the previous 4 months
- •60 day prescriptions: Filled a ezetimibe prescription within the previous 2.5 months
- •30 day prescriptions: Filled a ezetimibe prescription within the previous 1.5 months
- •Patients willing and able to provide signed informed consent
排除标准
- •Patients not receiving ezetimibe
- •Patients receiving ezetimibe 5 milligrams
- •Patients with a history of being titrated from ezetimibe 5 to 10 mg. Stroke,TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within the 3 months
- •Cancer undergoing active treatment
- •Participation in any clinical study within the last 30 days
- •Drug addiction or alcohol abuse within the past 6 months
- •Patients unwilling or unable to provide informed consent
- •Patients with poor compliance
- •Women of childbearing potential
研究组 & 干预措施
Ezetimibe 10 mg
Active Comparator
A whole ezetimibe 10 mg tablet
干预措施: Ezetimibe 10 mg (Drug)
Ezetimibe 5 mg
Experimental
Ezetimibe 5 mg, "formulated" by splitting a 10 mg ezetimibe tablet in half
干预措施: Ezetimibe 5 mg (Drug)
结局指标
主要结局
LDL Cholesterol
时间窗: 4 weeks
LDL cholesterol
次要结局
- Total Cholesterol(4 weeks)
研究者
Lawrence Baruch
Staff physician
Bronx VA Medical Center
研究点 (1)
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