NCT02749994已完成3 期
A Clinical Trial to Compare the Efficacy and Safety of a Combination Therapy of Ezetimibe and Rosuvastatin Versus Monotherapy of Rosuvastatin in Hypercholesterolemia Patients (I-ROSETTE Study)
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
- 396
- 试验地点
- 1
- 主要终点
- Percent change from baseline to 8 week in LDL-Cholesterol
研究概览
简要总结
A phase Ⅲ, multi-center, randomized, double-blinded, active comparator, factorial design clinical trial to compare the efficacy and safety of a combination therapy of ezetimibe and rosuvastatin versus monotherapy of rosuvastatin in hypercholesterolemia patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 ~ 79 years old
- •Patients who confirmed hypercholesterolemia.
- •Patients who requiring drug therapy according to NCEP ATP(National Cholesterol Education Program Adult Treatment Panel) III Guideline at Visit
- •Patients with Triglyceride< 400 at Visit
- •Patients who have a wash-out period over 4 weeks for other drugs that can affect lipid profile.(Patients who have lipid regulators should have washout period over six weeks)
- •Patients who agreed to participate in the trial
排除标准
- •Patients who have a history of myopathy or rhabdomyolysis by statin treatment or hypersensitivity to statin HMG CoA(3-hydroxy-3-methylglutaryl-coenzyme) reductase inhibitors) or ezetimibe.
- •A heavy alcohol consumer. (alcohol > 25 units/week)
- •Patients with severe renal disease. (creatinine ≥ 2.0 mg/dL)
- •Patients with active liver disease and AST(aspartate transaminase) or ALT(alanine transaminase) > 2 times of upper limit of normal range.
- •Patients with CPK(creatine phosphokinase) > 2 x upper limit of normal range.
- •Patients who have a endocrine or metabolic diseases known to affect the serum phospholipid or lipoprotein.
- •Patients with HIV(human immunodeficiency virus positive.
- •Patients who have a acute arteriopathy.
- •Patients with uncontrolled hypertension.
- •Patients who have hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- •Patients who have a drugs absorption disorder by gastrointestinal surgery or gastrointestinal disorder.
- •Patients with tumor.
- •Patients who have hormonal therapy.
- •Pregnancy or breastfeeding patients who don't agree to use adequate contraception.
- •Patients who are judged unsuitable to participate in this study by investigator.
- •Patients taking other clinical trial drugs within 30 days from the time of visit for screening.
研究组 & 干预措施
R5/E10
Experimental
Rosuvastatin 5mg/Ezetimibe 10mg
干预措施: Rosuvastatin (Drug)
R5
Active Comparator
Rosuvastatin 5mg
干预措施: Rosuvastatin (Drug)
R10
Active Comparator
Rosuvastatin 10mg
干预措施: Rosuvastatin (Drug)
R20
Active Comparator
Rosuvastatin 20mg
干预措施: Rosuvastatin (Drug)
R5/E10
Experimental
Rosuvastatin 5mg/Ezetimibe 10mg
干预措施: Ezetimibe (Drug)
R10/E10
Experimental
Rosuvastatin 10mg/Ezetimibe 10mg
干预措施: Rosuvastatin (Drug)
R10/E10
Experimental
Rosuvastatin 10mg/Ezetimibe 10mg
干预措施: Ezetimibe (Drug)
R20/E10
Experimental
Rosuvastatin 20mg/Ezetimibe 10mg
干预措施: Rosuvastatin (Drug)
R20/E10
Experimental
Rosuvastatin 20mg/Ezetimibe 10mg
干预措施: Ezetimibe (Drug)
结局指标
主要结局
Percent change from baseline to 8 week in LDL-Cholesterol
时间窗: baseline and 8 week
次要结局
- Percent change from baseline to 4 and 8 week in Triglyceride(baseline to 4 and 8 week)
- Percent change from baseline to 4 and 8 week in HDL-Cholesterol(baseline to 4 and 8 week)
- Percent change from baseline to 4 and 8 week in non-HDL-Cholesterol(baseline to 4 and 8 week)
- Percent change from baseline to 4 and 8 week in Total Cholesterol(baseline to 4 and 8 week)
- Percent change from baseline to 4 and 8 week in Apolipoprotein B(baseline to 4 and 8 week)
- Percent change from baseline to 4 and 8 week in Apolipoprotein A1(baseline to 4 and 8 week)
- Percent change from baseline to 4 week in LDL-Cholesterol(baseline to 4 week)
- Percent change from baseline to 4 and 8 week in hs-CRP(high-sensitivity C-reactive protein)(baseline to 4 and 8)
- The change of LDL-Cholesterol/HDL-Cholesterol ratio(baseline to 4 and 8 week)
- The change of Total Cholesterol/HDL-Cholesterol ratio(baseline to 4 and 8 week)
- The change of non-HDL-Cholesterol/HDL-Cholesterol ratio(baseline to 4 and 8 week)
- The change of Apolipoprotein B/Apolipoprotein A1 ratio(baseline to 4 and 8 week)
- The ratio of subjects who reach the goal of LDL-Cholesterol according to NCEP(National Cholesterol Education Program Adult Treatment Panel) III Guideline(baseline to 4 and 8 week)
研究者
研究点 (1)
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