NCT03597412已完成4 期
Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy Versus Rosuvastatin Monotherapy in Atherosclerotic Cardiovascular Disease (ASCVD) Patients With Type 2 Diabetes Mellitus (DM)
Yuhan Corporation1 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2018年10月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- Change from baseline to week 24 in LDL-C level
研究概览
简要总结
This study will evaluate the efficacy and aafety of rosuvastatin/ezetimibe combination therapy vs. rosuvastatin monotherapy in atherosclerotic cardiovascular disease patients with type 2 diabetes mellitus
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 19 and above
- •Patient with type 2 diabetes taking oral diabetes medication for at least 3 months
- •Patient diagnosed with ASCVD
- •Myocardial Infarction (MI)
- •Acute coronary syndrome (ACS)
- •History of Coronary revascularization(Percutaneous Coronary Intervention, PCI)
- •History of Coronary artery bypass graft surgery (CABG) or other arterial revascularization procedures
- •Stroke or Transient ischemic attack (TIA)
- •Peripheral Arterial Disease (PAD)
- •Stable Angina
- •Written informed consent
排除标准
- •Type 1 diabetes
- •HbA1c > 8.5% at screening
- •Fasting triglyceride ≥ 400 mg/dL at screening
- •History of muscular disease or rhabdomyolysis due to use of statin
- •Hypersensitive to rosuvastatin or ezetemibe
- •Contraindications stated in the SPC of rosuvastatin or rosuvastatin/ezetimibe including the following:
- •① Severe renal disease (CrCL < 30mL/min: Cockcroft-gault formula or estimated GFR (MDRD) < 30mL/min/1.73m2)
- •② ALT, AST > 3x ULN or history of active liver disease
- •③ CPK > 3x ULN
- •Those participating in clinical trials of other drugs
- •Other 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/Ezetimibe 10mg qd for 24 weeks
干预措施: Rosuvamibe (Drug)
Monorova Tab
Active Comparator
Rosuvastatin 20mg qd for 24 weeks
干预措施: Monorova (Drug)
结局指标
主要结局
Change from baseline to week 24 in LDL-C level
时间窗: Baseline, Week 24
次要结局
- Change from baseline to week 12 in LDL-C level(Baseline, Week 12)
- Change from baseline to week 12 and week 24 in total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG)(Baseline, Week 12, Week 24)
- Change from baseline to week 12 and week 24 in high-sensitivity C-reactive protein (hs-CRP)(Baseline, Week 12, Week 24)
- Change from baseline to week 12 and week 24 in homeostasis model assessment for insulin resistance (HOMA-IR)(Baseline, Week 12, Week 24)
- Change from baseline to week 12 and week 24 in glycosylated hemoglobin (HbA1c)(Baseline, Week 12, Week 24)
- Proportion of subjects achieving LDL-C < 55mg/dL(Baseline, Week 12, Week 24)
- Change from baseline to week 12 and week 24 in Apolipoprotein A1, Apolipoprotein B, Apolipoprotein B48, and Apolipoprotein B/Apolipoprotein A1(Baseline, Week 24)
- Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG)(Baseline, Week 12, Week 24)
- Occurrence of MACCE (Major Adverse Cardiovascular and Cerebrovascular Event)(Up to 24 weeks)
- Proportion of subjects achieving LDL-C < 70mg/dL(Baseline, Week 12, Week 24)
研究者
研究点 (1)
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