KCT0001831已完成未知
A multi center, randomized, double-blind, parallel, factorial design, therapeutic confirmatory(phase III) study to evaluate the efficacy and safety of combination of Rosuvastatin and Ezetimibe in patients with primary hypercholesterolemia
Daegu Catholic Univercity Medical Center0 个研究点目标入组 420 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 420
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •Aged over 19 years
- •Signed informed consent form
- •At visit 1 and visit 2(pre-visit2), LDL-Cholesterol = 250mg/dL and Triglyderide = 400mg/dL
- •after 4 weeks(at least) TLC(Therapeutic Lifestyle Change) and meet requirements for 4 group below.
- •? high-risk group: CHD(Coronary Heart Disease) or equal to CHD(Coronary Heart Disease) risk factor(10-yaear risk=20%),
- •100=LDL-C(mg/dL)=250 , TG(mg/dL)=400
- •? moderate high-risk group:having at least 2 risk factor, 10%=10-yaear risk<20%,
- •130=LDL-C(mg/dL)=250 , TG(mg/dL)=400
- •? moderate-risk grop: having at least 2 risk factor, 10-yaear risk<10%
- •160= LDL-C(mg/dL)=250 , TG(mg/dL)=400
- •? low-risk group: having 0~1 rkisk factor, 160= LDL-C(mg/dL)=250 , TG(mg/dL)=400
排除标准
- •1)At visit 1, BMI = 30kg/?
- •2)Has a history of myopathy or rhabdomyolysis cased by statin treatment, hereditary myopathy or family history and hypersensitivity to satin(HMG-CoA reductase inhibitor) and component of ezeimibe
- •3)Has a Severe renal disorder(Ccr <30mL/min) or nephrotic syndrome
- •4)Creatine Kinase > 2 x upper limit of normal
- •5)alanine aminotransferase(ALT) or aspartate aminotransferase(AST) > 3 x upper limit of normal
- •6)Has a activity/chronic hepatic disease or HIV-positive
- •7)Has a endocrine or metabolic diseases known to affect the serum phospholipid or poprotein
- •Uncontrolled diabete mellitus(HbA1c =9%)
- •Hypothyroidism (thyroid-stimulating hormone(TSH) > 1.5 x upper limit of normal at the screening )
- •8)Uncontrolled hypertension ((systolic blood pressure(SBP) =180mmHg ?? diastolic blood pressure(DBP) =110mmHg)
- •9)Has a acute arteriopathy(history of unstable angina, cardiac infarction, transient ischemic stroke, cerebrovascular disease, coronary artery bypass, coronary intervention within 12 weeks prior to screening)
- •10)Congestive heart failure (New York Heart Association(NYHA)Class III or IV)
- •11)Has a drugs absortion disorder by gastrointestinal surgery or gastrointestinal disorder
- •12)History of malignant tumor including myelogenous and lymphoma within 5 years
- •13)Subject with genetic deficiency such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
- •14)Female subjects of childbearing potential who disagree with the contraceptive methods(surgical sterilization, intrauterine device or condoms)
- •15)Pregnant or breast-feeding
- •16)Patients who have a drug or alcohol abuse or are being treated for psychological disorder.
- •17)Patients who were treated with other clinical trial drug within 12 weeks prior to screening
- •18)Others; patients considered inappropriate to participate in the study by the investigator.
研究者
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