NCT01414803已完成4 期
Tolerability and Efficacy of Rosuvastatin - Fenofibrate Combine Therapy in Korean Patients With Combined Hyperlipidemia
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
- 180
- 试验地点
- 1
- 主要终点
- Incidence of elevation of CK>5x ULN or AST>3x ULN or ALT>3x ULN
研究概览
简要总结
Although the combination of statin and fenofibrate is one of the options for patients with combined hyperlipidemia, non-lipid effects of it has not been completely understood yet. In this study we compared the effects of rosuvastatin 10 mg/fenofibrate 160 mg combination and rosuvastatin 10 mg monotherapy on muscle and liver enzyme, homocysteine levels, kidney, blood glucose control, and blood cell counts.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mixed hyperlipidemia: total cholesterol levels higher than 220 mg/dL, triglyceride (TG) levels between 200 and 500 mg/dL, and low-density lipoprotein (LDL)-cholesterol levels higher than 130 mg/dL after 6-week diet/life style change
- •Men and women who were between 20 and 70 years of age
- •Having at least one history of: coronary artery disease, cerebrovascular disease or transient ischemic attack, peripheral vascular disease, or diabetes mellitus.
- •Having risk factors at least two of: age ≥45 years in male or ≥55 years in female, elevated blood pressure (systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg, or treatment of previously diagnosed hypertension), high-density lipoprotein (HDL)-cholesterol <40 mg/dL, family history of coronary artery disease at age <55 years in male or <65 years in female, central obesity (waist circumference ≥90 cm for male or ≥80 cm for female), fasting plasma glucose ≥110 mg/dL, or left ventricular hypertrophy on electrocardiogram
- •Written informed consent.
排除标准
- •pregnant or breast-feeding
- •uncontrolled hypertension
- •uncontrolled diabetes mellitus
- •thyroid dysfunction
- •serum transaminase level >2 times the upper limit of normal
- •history of gall bladder disease
- •chronic alcoholic
- •serum creatinine level >1.5 mg/dL
- •history of myopathy
- •history of acute myocardial infarction or acute stroke within 3 months before the study began
- •acute or chronic infection or inflammation
- •history of cancer
- •history of adverse events associated with test drugs.
研究组 & 干预措施
rosuvastatin/fenofibrate combination
Experimental
rosuvastatin 10 mg/fenofibrate 160 mg per day
干预措施: Lipid modification (Drug)
rosuvastatin monotherapy
Active Comparator
rosuvastatin 10 mg per day
干预措施: Lipid modification (Drug)
结局指标
主要结局
Incidence of elevation of CK>5x ULN or AST>3x ULN or ALT>3x ULN
时间窗: 24 weeks after drug treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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