NCT03536598已完成3 期
A Double-blind, Randomized, Multi-center Phase III Clinical Trial to Evaluate the Safety and Efficacy of CJ-30060 Compared With Amlodipine/Valsartan Combination Therapy and Valsartan/Rosuvastatin Combination Therapy in Hypertensive Patients With Hyperlipidemia
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
- 203
- 主要终点
- Change of LDL-C and siSBP
研究概览
简要总结
To evaluate the safety and efficacy of CJ-30060 compared with amlodipine/valsartan combination therapy and valsartan/rosuvastatin combination therapy in hypertensive patients with hyperlipidemia
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 19 and 74 years
- •Patient with dyslipidemia and hypertension
排除标准
- •At screening, siSBP ≥ 200 mmHg or siDBP ≥ 120mmHg or LDL-C > 250mg/dL or TG ≥ 400mg/dL
- •At screening, siSBP difference is ≥ 20 mmHg or siDBP difference is ≥10 mmHg
- •Secodary hypertension
- •Type I or uncontrolled diabetes mellitus (HbA1c ≥ 9 %)
研究组 & 干预措施
Test
Experimental
Amlodipine 10mg + Valsartan 160mg + Rosuvastatin 20mg
干预措施: Amlodipine 10 mg + Valsartan 160 mg + Rosuvastatin 20 mg (Drug)
Reference 1
Active Comparator
Amlodipine 10mg + Valsartan 160mg
干预措施: Amlodipine 10 mg + Valsartan 160 mg (Drug)
Reference 2
Active Comparator
Valsartan 160mg + Rosuvastatin 20mg
干预措施: Valsartan 160 mg + Rosuvastatin 20 mg (Drug)
结局指标
主要结局
Change of LDL-C and siSBP
时间窗: baseline and 8 weeks
Mean change from baseline in LDL-C and siSBP at Week 8
次要结局
未报告次要终点
研究者
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Unknown
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