NCT00990808已完成1 期
A Multiple Dose Study to Investigate the Effect of MK0859 on Lipoprotein Metabolism When Added to Ongoing Statin Therapy in Dyslipidemic Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 主要终点
- Difference in Production Rate (PR) and Fractional Catabolic Rate (FCR) of Low Density Lipoprotein (LDL) apoB100 following treatment with MK0859 and atorvastatin versus atorvastatin alone
研究概览
简要总结
This study will investigate the effect of MK0859 on lipoprotein metabolism in patients with dyslipidemia already on statin therapy.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient's weight has been stable for at least 6 weeks
- •Patient is in good health based on medical history, physical exam, and laboratory tests
- •Patient has dyslipidemia
- •Exclusion Criteria :
- •Patient has a history of stroke, seizures, or major neurological disorders
- •Patient has a history of cancer
- •Patient is currently taking any lipid-lowering medications or substances except for statins
- •Patient consumes excessive amounts of alcohol or caffeine
- •Patient has multiple and/or severe allergies to food or drugs
排除标准
- 未提供
研究组 & 干预措施
Panel A
Experimental
Period 1: atorvastatin + placebo to MK0859; Period 2: atorvastatin + MK0859
干预措施: anacetrapib (Drug)
Panel B
Experimental
Period 1: placebo to atorvastatin + placebo to MK0859; Period 2: MK0859 + placebo to atorvastatin
干预措施: anacetrapib (Drug)
结局指标
主要结局
Difference in Production Rate (PR) and Fractional Catabolic Rate (FCR) of Low Density Lipoprotein (LDL) apoB100 following treatment with MK0859 and atorvastatin versus atorvastatin alone
时间窗: 12 weeks
次要结局
- Difference in FCR of LDL apoB100 following treatment with MK0859 versus placebo(12 weeks)
研究者
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