NCT03951207已完成4 期
Randomized, Multicenter, Parallel, Open, Phase 4 Study to Compare the Efficacy and Safety of Rosuvastatin/Amlodipine Combination Therapy Versus Atorvastatin/Amlodipine Combination Therapy in Hypertension Patient With Dyslipidemia
Yuhan Corporation1 个研究点 分布在 1 个国家目标入组 259 人开始时间: 2019年5月30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
- 259
- 试验地点
- 1
- 主要终点
- Rate of change from baseline to week 8 in LDL-Cholesterol
研究概览
简要总结
This study is to Compare the Efficacy and Safety of Rosuvastatin/Amlodipine Combination Therapy Versus Atorvastatin/Amlodipine Combination Therapy in Hypertension patient with Dyslipidemia
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
- •Both man and woman who is over 19 years old
- •Patient with dyslipidemia and hypertension
- •Written informed consent
排除标准
- •Triglyceride ≥ 400 mg/dL at screening
- •Hypertensive patients who need antihypertensive medication except Amlodipine, β-blockers, RAS inhibitors
- •sSBP difference is ≥20 mmHg or sDBP difference is ≥10 mmHg
- •A history of rhabdomyolysis, myopathy
- •Patient with hypersensitivity to Statin or Amlodipine
- •Patients undergoing eGFR <30 mL/min/1.73 m2 (MDRD) at screening
- •AST(Aspartate Aminotransferase) or ALT(Alanine Aminotransferase) level ≥ 3x ULN (upper limit of normal range) or active liver disease
- •Creatine kinase (CK) level ≥ 5x ULN (upper limit of normal range)
- •Contraindications stated in the Label of Rosuampin or Caduet
- •Those participating in other clinical trials for investigational products at screening
- •Patients deemed to be ineligible to participate in the trial by investigator
研究组 & 干预措施
Rosuampin 10/5mg
Experimental
Rosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks
干预措施: Rosuampin 10/5mg (Drug)
Rosuampin 20/5mg
Experimental
Rosuvastatin 20mg/Amlodipine 5mg qd for 8 weeks
干预措施: Rosuampin 20/5mg (Drug)
Amlodipine/Atorvastatin 5/20mg
Active Comparator
Atorvastatin 20mg/Amlodipine 5mg qd for 8 weeks
干预措施: Amlodipine/Atorvastatin 5/20mg (Drug)
结局指标
主要结局
Rate of change from baseline to week 8 in LDL-Cholesterol
时间窗: Baseline/Week 8
次要结局
- Proportion of subjects who reached the therapeutic goal to week 8(Week 8)
- Rate of change from baseline to week 4, 8 in msSBP & msDBP in both arm(Baseline/Week 4, 8)
- Rate of change from baseline to week 4, 8 in glucose index(Baseline/Week 4, 8)
- The incidence of major adverse cardiovascular and cerebrovascular events (MACCE)(Week 8)
- Rate of change from baseline to week 4 in LDL-Cholesterol(Baseline/Week 4)
- Rate of change from baseline to week 4, 8 in lipid profile(without LDL-C)(Baseline/Week 4, 8)
- Rate of change from baseline to week 4, 8 in hs-CRP(Baseline/Week 4, 8)
- Rate of change from baseline to week 4, 8 in difference of msSBP & msDBP in both arm(Baseline/Week 4, 8)
研究者
研究点 (1)
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