NCT00703690终止2 期
A Multicenter, Double-Blind, Randomized, Placebo and Active-Controlled, Parallel Study to Evaluate the Lipid Altering Efficacy and Safety of MK0767 in Patients With Metabolic Syndrome and Dyslipidemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 436
- 主要终点
- a dose-response will be seen across the doses of MK0767 and placebo in lowering fasting triglyceride.
研究概览
简要总结
This is a clinical trial in patients with Metabolic Syndrome and Dyslipidemia to study the effects of MK0767 on triglycerides.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Metabolic Syndrome and Dyslipidemia age 21 to 65
- •Patients will be eligible for the study if their triglyceride levels are within protocol specified range and have at least 2 of the criteria for Metabolic Syndrome as defined by NCEP
排除标准
- •Patients with a history of diabetes mellitus, partial ileal bypass, intolerant to fibric acid derivatives, requiring continuous oral corticosteroids, taking anti-seizure medications, documented coronary heart disease, renal insufficiency, proteinuria, viral hepatitis, cholelithiasis or other gallbladder disease, pancreatitis, neoplastic disease
- •Patient is on cyclical estrogen medications
- •Patient has taken lipid-lowering agents including fibric acid derivatives, bile acid sequestrants, HMG CoA reductase inhibitors and nicotinic acid derivatives within 8 weeks or probucol within 1 year of prior to visit 2
研究组 & 干预措施
1
Experimental
MK0767; 2.5 mg/day
干预措施: MK0767 (Drug)
2
Experimental
MK0767; 5mg/day
干预措施: MK0767 (Drug)
3
Experimental
MK0767; 10 mg/day
干预措施: MK0767 (Drug)
结局指标
主要结局
a dose-response will be seen across the doses of MK0767 and placebo in lowering fasting triglyceride.
时间窗: After 12 weeks of treatment
次要结局
- MK0767 will be safe and well tolerated(throughout study and at 12 weeks)
研究者
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