NCT03571087已完成3 期
A Multi Center, Randomized, Double-blind, Parallel, Factorial Design, Therapeutic Phase III Study to Evaluate the Efficacy and Safety of Combination of Rosuvastatin and Ezetimibe in Patients With Primary Hypercholesterolemia
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
- 374
- 主要终点
- Percentage change in LDL-Cholesterol from baseline
研究概览
简要总结
The purpose of this study is to evaluate efficacy and safety of HL140 in patients with primary hypercholesterolemia.
详细描述
The purpose of this study is to demonstrate that the efficacy of combination drug of rosuvastatin/ezetimibe is superior to single rosuvastatin drug and to confirm the safety of combination drug of rosuvastatin/ezetimibe
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged over 19 years
- •Signed informed consent form
- •At visit 1 and visit 2, LDL-Cholesterol ≤ 250mg/dL and Triglyceride ≤ 400mg/dL
排除标准
- •At visit 1, BMI ≥ 30kg/㎡
- •Has a history of myopathy or rhabdomyolysis cased by statin treatment, hereditary myopathy or family history and hypersensitivity to statin(HMG-CoA reductase inhibitor) and component of ezetimibe
- •Has a Severe renal disorder(Ccr <30mL/min) or nephrotic syndrome
- •Creatine Kinase > 5 x upper limit of normal
- •ALT or AST > 3 x upper limit of normal
- •Has a activity/chronic hepatic disease or HIV-positive
- •Has a endocrine or metabolic diseases known to affect the serum phospholipid or protein
- •Uncontrolled diabetes mellitus(HbA1c ≥9%)
- •Hypothyroidism (TSH > 1.5 x upper limit of normal rate at the screening )
- •Uncontrolled hypertension (SBP ≥180mmHg or DBP ≥110mmHg)
- •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)
- •Severe heart failure (NYHA Class III or IV)
- •Has a drug absorption disorder by gastrointestinal surgery or gastrointestinal disorder
- •History of malignant tumor including myelogenous and lymphoma within 5 years (Participation is possible, if the tumor has not recurred for more than 5 years)
- •Subject with genetic deficiency such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
- •Female subjects of childbearing potential who disagree with the contraceptive methods(surgical sterilization, intrauterine device or condoms)
- •Pregnant or breast-feeding
- •Patients who have a drug or alcohol abuse or are being treated for psychological disorder
- •Patients who were treated with other investigational drug within 12 weeks prior to screening
- •Other patients who are inappropriate to participate in the study considered by the investigator or other study staffs
研究组 & 干预措施
HL140 5/10
Experimental
Treatment(W0~W8), Extension(W9~W20): : 6Tab./q.d. HL140 5/10(Rosuvastatin5mg/Ezetimibe10mg)
干预措施: HL140 5/10 (Drug)
HL140 10/10
Experimental
Treatment(W0~W8), Extension(W9~W20): : 6Tab./q.d. HL140 10/10(Rosuvastatin10mg/Ezetimibe10mg)
干预措施: HL140 10/10 (Drug)
HL140 20/10
Experimental
Treatment(W0~W8), Extension(W9~W20): : 6Tab./q.d. HL140 20/10(Rosuvastatin20mg/Ezetimibe10mg)
干预措施: HL140 20/10 (Drug)
Rosuvastatin 5mg → HL140 5/10
Experimental
- Treatment(W0~W8): 6Tab./q.d. Rosuvastatin 5mg
- Extension period(W9~W20): 6Tab./q.d. HL140 5/10(Rosuvastatin5mg/Ezetimibe10mg)
干预措施: Rosuvastatin 5mg → HL140 5/10 (Drug)
Rosuvastatin 10mg → HL140 10/10
Experimental
- Treatment(W0~W8): 6Tab./q.d. Rosuvastatin 10mg
- Extension period(W9~W20): 6Tab./q.d. HL140 10/10(Rosuvastatin10mg/Ezetimibe10mg)
干预措施: Rosuvastatin 10mg → HL140 10/10 (Drug)
Rosuvastatin 20mg → HL140 20/10
Experimental
- Treatment(W0~W8): 6Tab./q.d. Rosuvastatin 20mg
- Extension period(W9~W20): 6Tab./q.d. HL140 20/10(Rosuvastatin20mg/Ezetimibe10mg)
干预措施: Rosuvastatin 20mg → HL140 20/10 (Drug)
结局指标
主要结局
Percentage change in LDL-Cholesterol from baseline
时间窗: Week 8
Percentage change(%) in LDL-Cholesterol from baseline at week 8
次要结局
- Percentage change in TG from baseline(Week 4, Week 8)
- Percentage change in TC from baseline(Week 4, Week 8)
- Percentage of change in non-HDL-Cholesterol(Week 4, Week 8)
- The rate of change in hs-CRP(Week 4, Week 8)
- Percentage of patients reached treatment goals according to NCEP ATP III Guideline(Week 4, Week 8)
- Percentage change in LDL-Cholesterol from baseline(Week 4)
- Percentage of change in HDL-Cholesterol(Week 4, Week 8)
- Percentage of change weeks in Apo A-I(Week 4, Week 8)
- Percentage of change in Apo B(Week 4, Week 8)
- Percentage of change in Lipoprotein(a)(Week 4, Week 8)
研究者
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