NCT01122355已完成4 期
Comparison of Fenofibrate and Niacin in Patients With Hypertriglyceridemia and Low High-Density Lipoprotein (HDL)-Cholesterol
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 240
- 主要终点
- percent change of apoB/A1
研究概览
简要总结
The purpose of the study is to compare the efficacy and tolerability of fenofibrate 160 mg and niacin 1500 mg in patients with hypertriglyceridemia and low HDL-cholesterol. The primary end point is the percent change of apoB/A1 and the secondary end points are other lipid parameters and biomarkers.
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
- None
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Triglyceride 150-500 mg/dL and HDL-cholesterol < 45 mg/dL after 8 week dietary run in period
- •20-79 years old
排除标准
- •Low-density lipoprotein (LDL)-cholesterol ≥ 130 mg/dL without any lipid-modifying drug
- •History of cerebrovascular or cardiovascular diseases
- •Creatinine > 2.0 mg/dL
- •Transaminase > 2x upper limit of normal
- •Gall bladder disease
- •Pregnant or breast feeding women
- •History of adverse events associated with test drugs
研究组 & 干预措施
niacin arm
Active Comparator
干预措施: lipid modification (Drug)
fenofibrate arm
Active Comparator
干预措施: lipid modification (Drug)
结局指标
主要结局
percent change of apoB/A1
时间窗: after 16 weeks of drug treatment
次要结局
未报告次要终点
研究者
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