NCT02035215Unknown3 期
Efficacy and Safety of Co-administration of Omacor Plus Atorvastatin Compared With Atorvastatin Monotherapy in Patients With Type Ⅱb Dyslipidemia: a Multicenter, Double-blind, Randomized, Active-controlled, Parallel, Phase Ⅲ Study
Kuhnil Pharmaceutical Co., Ltd.4 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- The mean percent change of Triglyceride(TG)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of combination therapy of omega-3-acids ethylesters 90/Atorvastatin calcium in type Ⅱb hyperlipidemia
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LDL≥160mg/dl, 200mg/dl≤TG<500mg/dl
- •In the case of smokers, he agrees should be smoke-free
- •In the case of women of childbearing age, urine pregnancy test must be negative
排除标准
- •Patients with acute artery disease within 3 months
- •History of revascularization procedure or aneurism operation within 6months
- •Patients with myopathy, rhabdomyolysis
- •Patients with pancreatitis
- •Patients with HIV positive
- •History of malignant tumor within 2 years
- •Patients must be treated with medications prohibited for concomitant use during study period
- •Patients with uncontrolled hypertension(SBP>180mmHg or DBP>110mmHg)
- •Serum Creatinine>1.2mg/dl(female), >1.4mg/dl(male)
- •AST or ALT > 2X ULN
- •CPK > 2X ULN
- •Patients with galactose intolerance or Lapp lactase deficiency, glucose-galactose malabsorption
- •Allergy or Hypersensitive to investigational drug
- •History of drug or alcohol abuse within 2 years
- •In the case of smokers, who do not intend to non smoking
- •Women with pregnant, breast-feeding
- •Patients treated with any investigational drugs within 1 month at the time consents are obtained
- •Not eligible to participate for the study at the discretion of investigator
研究组 & 干预措施
Atorvastatin 20mg, Omega-3-acids ethylesters 90 4g
Experimental
Atorvastatin calcium 20mg, Omega-3-acids ethylesters 90 4g: po, q.d
干预措施: Atorvastatin 20mg (Drug)
Atorvastatin 20mg, Omega-3-acids ethylesters 90 4g
Experimental
Atorvastatin calcium 20mg, Omega-3-acids ethylesters 90 4g: po, q.d
干预措施: Omega-3-acids ethylesters 90 4g (Drug)
Atorvastatin 20mg, Placebo
Placebo Comparator
Atorvastatin calcium 20mg, Placebo for Omega-3-acids ethylesters 90 4g: po, q.d
干预措施: Atorvastatin 20mg (Drug)
Atorvastatin 20mg, Placebo
Placebo Comparator
Atorvastatin calcium 20mg, Placebo for Omega-3-acids ethylesters 90 4g: po, q.d
干预措施: Placebo(Omega-3-acids ethylesters 90) (Other)
结局指标
主要结局
The mean percent change of Triglyceride(TG)
时间窗: from baseline at week 8
次要结局
- The mean percent change of Triglyceride(TG)(from baseline at week 4)
- The mean percent change of Total Cholesterol(TC), LDL-C, HDL-C(from baseline at week 4,8)
研究者
研究点 (4)
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