Comparison of the Efficacy and AtorVastatin 20mg mOnotherapy Versus Combination Atorvastatin/Fenofibric Acid 10/135mg in the Mixed hyperlipiDemia Who Were Not at Lipid gOals With Atorvastatin 10mg Monotherapy.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- levelresponse rate of non-HDL cholesterol level < 130mg/dL
研究概览
简要总结
The purpose of this study is to compare combination atorvastatin/fenofibric acid 10/135mg with atorvastatin 20mg monotherapy in the mixed hyperlipidemia who were not at lipid goals with atorvastatin 10mg monotherapy.
详细描述
Study conduct according to the standard operating procedure
- The sponsor, the investigator, and all other persons involved in the study at the study center or other facilities should conduct the study in accordance with the study protocol, each standard operating procedure, and Korea Good Clinical Pratice.
Data quality control
- In order to ensure the reliability of all study-related data and their appropriate processing, the sponsor will apply quality control to each step of data handling
Monitoring
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients of the age of 20years or older
- •patients who have been taking atorvastatin 10mg 1 tab per day for more than 8 weeks before screening
- •patients who meet the following criteria
- •Low density lipoproteins-cholesterol level < 130mg/dL
- •150mg/dL < Triglyceride level < 500mg/dL
- •HDL-cholesterol level < 45mg/dL
- •patients who consent for the consent before enrolling the study
排除标准
- •Allergic to HMG-CoA reductase inhibitor and fibrates
- •uncontrolled Hypertension
- •unstable angina, myocardial infarction, transient ischemic attack
- •uncontrolled diabetes
- •thyroid disease
- •myopathy, rhabdomyolysis history
- •alcoholic
- •chronic diarrhea, gastrointestinal disease
- •malignant tumor
- •patients who are pregnant
- •lactating woman
研究组 & 干预措施
Atorvastatin 20mg, monotherapy
Atorvastatin 20mg/day PO for 12weeks
干预措施: atorvastatin 20mg (Drug)
Atorvastatin 10mg, Fenofibric acid 135mg
Atorvastatin 10mg, Fenofibric acid 135mg per day PO for 12weeks
干预措施: Atorvastatin 10mg, fenofibric acid 135mg (Drug)
结局指标
主要结局
levelresponse rate of non-HDL cholesterol level < 130mg/dL
时间窗: at screening and after 12 weeks
-Response rate : (subjects who are at less than 130mg/dL of non-High density lipoprotein level / all subjects) \* 100
Changes of non-HDL cholesterol
时间窗: at screening and after 12 weeks
-change rate : \[(12nd week non-High density lipoprotein - baseline non-High density lipoprotein) / baseline non-High density lipoprotein\] \* 100
次要结局
- changes of TC,HDL-C,LDL-C,TG,Apo B/A1(at screening and after 12 weeks)
- Changes of Glucose, HbA1c, HOMA-IR level(at screening and after 12 weeks)
- Changes of hs-CRP, adiponectin, resistin level(at screening and after 12 weeks)
研究者
Sang Hak Lee
Associate Professor in Cardiology(preventive cardiology) in Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea
Yonsei University