NCT00269217已完成3 期
A Multicenter, Randomized, Double-Blind, "Factorial" Design Study to Evaluate the Lipid-Altering Efficacy and Safety of Coadministered MK0524B Tablets in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,400
- 主要终点
- Coadministered MK0524B will be more efficacious in reducing LDL-C concentrations compared to MK0524A.
研究概览
简要总结
This is a 12-week clinical trial in patients with primary hypercholesterolemia or mixed hyperlipidemia, studying the effects of coadministered MK0524B on lipids. There will be 6 scheduled clinic visits, and 7 treatment arms.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 to 85 years of age with primary hypercholesterolemia or mixed hyperlipidemia
- •LDL-C between 130 and 190 mg/L (Category I) and 130 and 160 mg/L (Category II) and triglycerides </= 350 mg/dL.
排除标准
- •A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study
- •Patients with <80% compliance
- •Patients with certain medical conditions
- •Patients taking certain concomitant medications and/or with unstable doses of medications
- •Or those with a history of CHD/CHD equivalent or diabetes
结局指标
主要结局
Coadministered MK0524B will be more efficacious in reducing LDL-C concentrations compared to MK0524A.
次要结局
- Coadministered MK0524B will have a greater effect on HDL-C, TG, LDL-C, LDL-C:HDL-C, non-HDL-C, Apo B, and Apo A-I than simvastatin.
- Coadministered MK0524B will have a greater effect on HDL-C, TG, LDL-C:HDL-C, non-HDL-C, Apo B, and Apo A-I than MK0524A.
研究者
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