NCT03446261已完成4 期
A Randomized, Multicenter, Open, Parallel, Phase 4 Study to Compare the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy vs Rosuvastatin Monotherapy in Korean Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia
Yuhan Corporation1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2018年2月23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
- 140
- 试验地点
- 1
- 主要终点
- Change from baseline to week 8 in ApoB/ApoA1 ratio
研究概览
简要总结
To assess the efficacy and safety of rosuvastatin/ezetimibe combination therapy compared to rosuvastatin monotherapy in Korean patients with type 2 diabetes mellitus and hypercholesterolemia
详细描述
This study is to assess the efficacy and safety of Rosuvamibe® (rosuvastatin 5mg/ezetimibe 10mg) vs Monorova® (rosuvastatin 10mg) treated for 8 weeks in Korean patients with type 2 diabetes mellitus and hypercholesterolemia.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 19 to 70 years
- •Patient with type 2 diabetes who needs treatment for hypercholesterolemia
- •Written informed consent
排除标准
- •Administration of lipid lowering agents for more than one week within 4 weeks prior to screening visit
- •Uncontrollable diabetes with HbA1c ≥ 8.5%
- •Fasting LDL-C ≤ 70 mg/dL
- •Fasting triglyceride ≥ 400 mg/dL
- •Total cholesterol ≥ 300 mg/dL
- •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 (estimated GFR(MDRD) < 30mL/min/1.73m2)
- •② ALT, AST > 3x ULN or history of active liver disease
- •③ CPK > 3x ULN
- •Administration of other investigational products within 30 days prior to screening visit
- •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
Rosuvamibe® Tab (rosuvastatin 5mg/ezetimibe 10mg) qd for 8 weeks
干预措施: Rosuvamibe® Tab (Drug)
Monorova® Tab
Active Comparator
Monorova® Tab (rosuvastatin 10mg) qd for 8 weeks
干预措施: Monorova® Tab (Drug)
结局指标
主要结局
Change from baseline to week 8 in ApoB/ApoA1 ratio
时间窗: Baseline, Week 8
次要结局
- Proportion of subjects achieving the comprehensive lipid target (LDL-C<70mg/dL, Non-HDL-C<100mg/dL, and ApoB<80mg/dL)(Baseline, Week 8)
- Change from baseline to week 8 in FPG(Baseline, Week 8)
- Change from baseline to week 8 in hs-CRP(Baseline, Week 8)
- Change from baseline to week 8 in HbA1C(Baseline, Week 8)
- Change from baseline to week 8 in HOMA-IR(Baseline, Week 8)
- Proportion of over 50% reduction in LDL-C(Baseline, Week 8)
- Change from baseline to week 8 in total, non-HDL, LDL and HDL cholesterol, triglyceride, ApoB, ApoA1 and ApoB48(Baseline, Week 8)
研究者
研究点 (1)
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