NCT02145104已完成3 期
Comparison of the Efficacy and Safety of Cilnidipine 10mg/Valsartan 160mg Combination Therapy, Cilnidipine 5mg/Valsartan 160mg Combination Therapy and Valsartan 160mg Monotherapy in Hypertensive Patients Inadequately Controlled With Valsartan 160mg Monotherapy: a Multicenter, Randomized, Double Blind Phase III Study
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
- 286
- 试验地点
- 1
- 主要终点
- change from baseline in mean sDBP
研究概览
简要总结
The purpose of this study is to evaluate of efficacy and safety of cilinidipine plus valsartan and valsartan alone in patients with essential hypertension inadequately controlled on valsartan monotherapy
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •essential hypertension patients whose blood pressure is not controlled before the study (sDBP≥90mmHg for drug-treated patients, sDBP≥95mmHg for drug-naive patients)
排除标准
- •sSBP≥80mmHg after 4weeks of valsartan 160mg treatment
- •has a history of hypersensitivity to dihydropyridines or angiotensin II receptor blockers
研究组 & 干预措施
Arm A
Experimental
cilinidpine 10mg + valsartan 160mg
干预措施: valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg (Drug)
Arm B
Experimental
cilnidipine 5mg + valsartan 160mg
干预措施: valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg (Drug)
Arm C
Active Comparator
valsartan 160mg
干预措施: valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg (Drug)
结局指标
主要结局
change from baseline in mean sDBP
时间窗: 8 weeks
次要结局
- change from baseline in mean sDBP(4 weeks)
- change from baseline in mean sSBP(4, 8 weeks)
研究者
研究点 (1)
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