NCT03618797已完成3 期
A Multicenter, Randomized, Double-blinded, Parallel, Therapeutic Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of Pitavastatin Versus Pitavastatin/Fenofibrate in Complex-dyslipidemia Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 347
- 主要终点
- The mean percentage change of Non-HDL Cholesterol
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Pitavastatin versus Pitavastatin/Fenofibrate in complex-dyslipidemia patients.
详细描述
The purpose of this study is to demonstrate the efficacy of the Pitavastatin/Fenofibrate in complex-dyslipidemia patients by the reduction of non-HDL-Cholesterol levels compared with Pitavastatin.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High risk patient to Coronary Heart Disease
- •At visit 1(Screening)
- •If treated with Pitavastatin 2mg monotherapy 4 weeks prior to this study : LDL-C<100mg/dL and 150mg/dL≤TG<500mg/dL, randomize without run-in period
- •If non treated with Pitavastatin 2mg monotherapy 4 weeks prior to this study : LDL-C≥100mg/dL and 150mg/dL≤TG<500mg/dL, treatment of Pitavastatin 2mg for 4 weeks(run-in period)
- •LDL-C<100mg/dL and 150mg/dL≤TG<500mg/dL after 4 weeks of Pitavastatin 2mg monotherapy
排除标准
- •Subject with acute artery disease
- •Subject with congestive heart failure(NYHA class III~IV) or uncontrolled arrhythmia
- •Secondary or iatrogenic dyslipidemia caused by hypothyroidism, nephrotic syndrome etc.
- •AST or ALT > 2XULN, Serum Creatinine > 2.5mg/dL, Creatinine phosphokinase > 2XULN
- •Subject with gall bladder disease or pancreatitis
- •Uncontrolled hypertension
- •Endocrine or metabolic disease affected on serum lipid or liprotein
- •Subject with medical history of myopathy or rhabdomyolysis caused by Statin treatment, hereditary myopathy or family history
- •Not eligible to participate for the study at the discretion of investigator
研究组 & 干预措施
HL-PIF cap.160/2mg + Placebo
Experimental
- Fenofibrate pellet (as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg
- once a day
干预措施: HL-PIF cap.160/2mg + Placebo (Drug)
Livalo tab. 2mg + Placebo
Active Comparator
- Pitavastatin ca 2mg
- once a day
干预措施: Livalo tab. 2mg + Placebo (Drug)
结局指标
主要结局
The mean percentage change of Non-HDL Cholesterol
时间窗: from baseline at week 8
Change rate of Non-HDL-C after 8 weeks compared to baseline (%)
次要结局
- The mean percentage change of non-HDL-C/HDL-C(from baseline at week 4,8)
- The mean percentage change of VLDL-C(from baseline at week 4,8)
- The mean percentage change of Non-HDL Cholesterol(from baseline at week 4)
- The mean percentage change of LDL-C(from baseline at week 4,8)
- The mean percentage change of HDL-C(from baseline at week 4,8)
- The mean percentage change of Apo Al(from baseline at week 4,8)
- The mean percentage change of Apo B(from baseline at week 4,8)
- The mean percentage change of Apo Al/Apo B(from baseline at week 4,8)
- The mean percentage change of fibrinogen(from baseline at week 4,8)
- The mean percentage change of hs-CRP(from baseline at week 4,8)
- Achievement rate(%) of treatment goals after 4 weeks and 8 weeks(from baseline at week 4,8)
- The mean percentage change of LDL-C/HDL-C(from baseline at week 4,8)
- The mean percentage change of TC/HDL-C(from baseline at week 4,8)
- The mean percentage change of TG(from baseline at week 4,8)
- The mean percentage change of TC(from baseline at week 4,8)
研究者
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