NCT03403556Unknown4 期
A Randomized, Multicenter, Open, Parallel, Phase 4 Study to Compare the Efficacy and Safety Between High-intensity Rosuvastatin and Moderate-intensity Rosuvastatin/Ezetimibe in High ASCVD Risk Patients With Type 2 diabEtes (CREATE Study)
Yuhan Corporation6 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2018年3月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 140
- 试验地点
- 6
- 主要终点
- Mean percent change from baseline to week 24 in low-density lipoprotein cholesterol (LDL-C)
研究概览
简要总结
To assess the efficacy and safety of moderate-intensity rosuvastatin/ezetimibe compared to high-intensity rosuvastatin in high atherosclerotic cardiovascular disease risk patients with type 2 diabetes
详细描述
This study is to assess the efficacy and safety of Rosuvamibe® (rosuvastatin 10mg/ezetimibe 10mg) vs. rosuvastatin 20mg treated for 24 weeks in atherosclerotic cardiovascular disease risk (≥ 7.5%) patients with type 2 diabetes
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
- None
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Type 1 diabetes
- •Chronic hepatitis B or chronic hepatitis C, severe hepatic dysfunction (AST, ALT, ALP or CPK ≥ 3 x ULN) in screening
- •Heavy drinking > 210g per week in screening
- •Estimated GFR < 30mL/min/1.73m2 using the CKD-EPI formula in screening
- •Undergoing renal replacement therapy (hemodialysis or peritoneal dialysis) in screening
- •Having used other statin (HMG-CoA converting enzyme inhibitors) than Rosuvastatin or fibrate drugs in the last 3 months before screening
- •Taking any medication (ex. Fenofibrate, Omega 3 fatty acid, etc.) that may affect LDL
- •* Can be enrolled after 4 week-washout
- •Having used thiazolidinedione drugs in the last 3 months before screening
- •Taking cyclosporine concomitantly
- •Positive HIV test in screening
- •Pregnant, breastfeeding, or childbearing women who are not likely to use the appropriate contraceptive methods as judged by investigator
- •Subjects with a medical history of myopathy and rhabdomyolysis due to use of statin
- •Hypersensitive to statin and ezetimibe
- •Having endocrine or metabolic disease known to affect serum lipids or lipoproteins
- •Uncontrolled diabetes (HbA1c ≥ 10%)
- •Uncontrolled thyroid dysfunction (TSH ≥ 3 x ULN)
- •Subjects with a medical history of acute arterial diseases such as unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass graft or percutaneous coronary intervention in the last 6 months before screening
- •Subjects with a surgical history of gastrointestine or drug absorption disorders due to gastrointestinal disorders
- •Insulin-treated
- •Taking other IPs in the last 30 days before screening
- •Subjects who cannot discontinue contraindications that may affect the treatment of all types of diabetes and/or hypercholesterolemia during the study period
- •Subjects with a significant or unstable medical or psychological condition that is judged by investigator to be detrimental to safety or to successful participation in the trial
- •Other conditions than the above who is deemed to be ineligible to participate in the trial by investigator
研究组 & 干预措施
Rosuvamibe ® Tab.
Experimental
Rosuvastatin 10mg/Ezetimibe10mg
干预措施: Rosuvamibe (Drug)
Monorova ® Tab.
Active Comparator
Rosuvastatin 20mg
干预措施: Monorova (Drug)
结局指标
主要结局
Mean percent change from baseline to week 24 in low-density lipoprotein cholesterol (LDL-C)
时间窗: Up to 24 weeks
次要结局
- Mean change from baseline to week 24 in calculated LDL cholesterol(mg/dL), HDL cholesterol(mg/dL), Triglyceride(mg/dL), non-HDL cholesterol(mg/dL), Apolipoprotein B(mg/dL), Apolipoprotein A1(mg/dL)(Up to 24 weeks)
- Proportion of subjects achieving < 7.5% 10-year ASCVD risk without withdrawn due to adverse events(Up to 24 weeks)
- Mean change from baseline to week 24 in Fatty Liver Index (FLI)(Up to 24 weeks)
- Mean change from baseline to week 24 in Hepatic Steatosis Index (HSI)(Up to 24 weeks)
- Mean change from baseline to week 12 and to week 24 in 10-year ASCVD risk(Up to 12 weeks, Up to 24 weeks)
- Proportion of subjects achieving the comprehensive lipid target (LDL-C < 70mg/dL, Non-HDL-C < 100mg/dL, and Apolipoprotein B < 80mg/dL) without withdrawn due to adverse events(Up to 24 weeks)
- Mean change from baseline to week 24 in non-alcoholic fatty liver disease liver fat score (NAFLD-LFS)(Up to 24 weeks)
- Mean change from baseline to week 24 in HbA1c(Up to 24 weeks)
- Mean change from baseline to week 24 in sCD36(Up to 24 weeks)
- Mean change from baseline to week 24 in HOMA-B(Up to 24 weeks)
- Mean change from baseline to week 24 in fasting plasma glucose (FPG)(Up to 24 weeks)
- Mean change from baseline to week 24 in HOMA-IR(Up to 24 weeks)
研究者
研究点 (6)
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