NCT03288038已完成3 期
A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy 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
- 382
- 试验地点
- 20
- 主要终点
- Percent change from baseline to 8 week in LDL-Cholesterol
研究概览
简要总结
A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy in Patients with Primary Hypercholesterolemia
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 years or older
- •Patients with primary hypercholesterolemia
- •Patients who were informed about the purpose, method, effects, risks of this clinical study and have provided a written consent form signed by him/herself or by a representative
- •those who show an LDL-C level of 250 mg/dL or below and a TG level of less than 350 mg/dL at the run-in period (Week -1), and fall under the criterion of requiring the administration of antidyslipidemic drug of NCEP ATP III
排除标准
- •Patients with hypersensitivity to the investigational product or its ingredients
- •Those with an uncontrolled hypertension (SBP ≧ 180 mmHg or DBP ≧ 100 mmHg)
- •Those with a history of unstable angina, myocardial infarction, transient ischemic attack, cerebral vascular disease, coronary artery bypass or coronary intervention within 3 months of screening date
- •Those with a history of malignant tumor within 5 years
- •Those with a history of myopathy or rhabdomyolysis
- •Those who show clinically significant confirmed laboratory test results (1) Patients showing AST or ALT level of greater than 2 times the institutional upper limit of normal or those with active liver disease or chronic hepatitis (2) A serum creatinine level greater than 2 times the institutional upper limit of normal (3) HbA1c > 9% (4) Those with TSH level of greater than 1.5 times the institutional upper limit of normal (5) Those with CK level greater than 2 times the institutional upper limit of normal (However, except for an increase caused by a recent trauma, intramuscular injection or strenuous exercise)
- •Those who were given, within 4 weeks prior to the baseline (8 weeks in case of fibrate) or are expected to be given during the study period, a drug that can have an effect on the efficacy assessment of the clinical study (eg: antidyslipidemic drug (statins, ezetimibe, fibrates, BAS, nicotinic acid and derivative, etc.), systemic glucocorticosteroids, steatolytic enzyme inhibitor, cyclosporine, HIV proteinase inhibitor, macrolide class antibiotics, etc.)
- •Patients who were given estrogen within 3 months from the screening or those who are expected to be given an administration during the study period. (However, a patient who is under a hormone replacement therapy (HRT) will be allowed if no dose change is expected in the course of the clinical study.)
- •Those with a history of alcohol or drug abuse
- •Patients with a hereditary disorder of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •Pregnant or breast-feeding women
- •Women of childbearing potential or men who do not intend to use an adequate contraceptive measure during the study period and for 4 weeks after the end of the study(Adequate contraception: Administration and transplantation of a progestin-only contraceptive pill, intrauterine device, condom, spermicidal agent, etc.)
- •Patients who participated in another clinical study within 3 months from the screening date or have not had a washout period of at least 5 times the half-life of the active ingredient of the previously administered investigational product, whichever is longer
- •Those with drug malabsorption
- •Patients who has been judged by the investigator to be ineligible to participate in the clinical study
研究组 & 干预措施
RSV20mg
Active Comparator
Rosuvastatin 20mg
干预措施: Rosuvastatin (Drug)
RSV10mg + EZE10mg
Experimental
Rosuvastatin 10mg/ Ezetimibe 10mg
干预措施: Rosuvastatin (Drug)
RSV20mg + EZE10mg
Experimental
Rosuvastatin 20mg/Ezetimibe 10mg
干预措施: Rosuvastatin (Drug)
RSV5mg + EZE 10mg
Experimental
Rosuvastatin 5mg/Ezetimibe 10mg
干预措施: Rosuvastatin (Drug)
RSV5mg + EZE 10mg
Experimental
Rosuvastatin 5mg/Ezetimibe 10mg
干预措施: Ezetimibe (Drug)
RSV5mg
Active Comparator
Rosuvastatin 5mg
干预措施: Rosuvastatin (Drug)
RSV10mg + EZE10mg
Experimental
Rosuvastatin 10mg/ Ezetimibe 10mg
干预措施: Ezetimibe (Drug)
RSV20mg + EZE10mg
Experimental
Rosuvastatin 20mg/Ezetimibe 10mg
干预措施: Ezetimibe (Drug)
RSV10mg
Active Comparator
Rosuvastatin 10mg
干预措施: Rosuvastatin (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 week in LDL-Cholesterol(baseline and 4 week)
- The ratio of the subjects who have reached the target LDL-C level according to the NCEP ATP(National Cholesterol Education Program Adult Treatment Panel) III Guideline at Week 4 and Week 8(baseline to 4 and 8 week)
- The change and percent change in the levels of TC, TG, HDL-C, non-HDL-C, apolipoprotein B, and hs-CRP from the baseline to Week 4 and Week 8(baseline to 4 and 8 week)
- The change and percent change in the ratios of LDL-C/HDL-C, TC/HDL-C, non-HDL-C/HDL-C, and Apo B/Apo A-I from the baseline to Week 4 and Week 8(baseline to 4 and 8 week)
- The change in the LDL-C level from the baseline to Week 4 and Week 8(baseline to 4 and 8 week)
研究者
研究点 (20)
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