A Randomized, Multicenter, Parallel Design Phase III Clinical Study to Evaluate the Efficacy and Safety of the Combination of Lercanidipine/Valsartan in Hypertensive Patients Who Are Not Adequately Controlled on Lercanidipine 10mg Monotherapy.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 449
- 试验地点
- 1
- 主要终点
- Change in mean sitDBP from week 0 to week 40
研究概览
简要总结
This study aims to compare and assess the efficacy and the safety of the combination agent of Lercanidipine and Valsartan and monotherapy of Lercanidipine alone in patients with essential hypertension
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
- •Patients aged ≥ 20 to ≤75 years old
- •Patient with essential hypertension
排除标准
- •When the BP level measured at screening was sitDBP>120 mmHg or sitSBP >180 mmHg
- •Patient with difference in repeatedly measured blood pressures from the selected arm at screening was sitSBP≥ 20mmHg or sitDBP ≥ 10mmHg
研究组 & 干预措施
Lercanidipine 10mg
1 Tablet of Zanidip ® 10mg + 1 Tablet of L10/V80 Placebo + 1 Tablet of L10/V160 Placebo (8wks)
干预措施: Lercanidipine 10mg (Drug)
Lercanidipine 10mg
1 Tablet of Zanidip ® 10mg + 1 Tablet of L10/V80 Placebo + 1 Tablet of L10/V160 Placebo (8wks)
干预措施: Lercanidipine10mg /Valsartan 80mg Placebo (Drug)
Lercanidipine 10mg
1 Tablet of Zanidip ® 10mg + 1 Tablet of L10/V80 Placebo + 1 Tablet of L10/V160 Placebo (8wks)
干预措施: Lercanidipine 10mg /Valsartan 160mg Placebo (Drug)
Lercanidipine10mg /Valsartan 80mg
1 Tablet of Zanidip ® 10mg Placebo +1 Tablet of L10/V80 + 1 Tablet of L10/V160 Placebo (8wks)
干预措施: Lercanidipine10mg /Valsartan 80mg (Drug)
Lercanidipine10mg /Valsartan 80mg
1 Tablet of Zanidip ® 10mg Placebo +1 Tablet of L10/V80 + 1 Tablet of L10/V160 Placebo (8wks)
干预措施: Lercanidipin 10mg Placebo (Drug)
Lercanidipine10mg /Valsartan 80mg
1 Tablet of Zanidip ® 10mg Placebo +1 Tablet of L10/V80 + 1 Tablet of L10/V160 Placebo (8wks)
干预措施: Lercanidipine 10mg /Valsartan 160mg Placebo (Drug)
Lercanidipine 10mg /Valsartan 160mg
1 Tablet of Zanidip ® 10mg Placebo + 1 Tablet of L10/V80 Placebo + 1 Tablet of L10/ V160 (8wks)
干预措施: Lercanidipine 10mg /Valsartan 160mg (Drug)
Lercanidipine 10mg /Valsartan 160mg
1 Tablet of Zanidip ® 10mg Placebo + 1 Tablet of L10/V80 Placebo + 1 Tablet of L10/ V160 (8wks)
干预措施: Lercanidipin 10mg Placebo (Drug)
Lercanidipine 10mg /Valsartan 160mg
1 Tablet of Zanidip ® 10mg Placebo + 1 Tablet of L10/V80 Placebo + 1 Tablet of L10/ V160 (8wks)
干预措施: Lercanidipine10mg /Valsartan 80mg Placebo (Drug)
结局指标
主要结局
Change in mean sitDBP from week 0 to week 40
时间窗: 40 weeks
次要结局
- Response rate at week 4 and 8(4 weeks and 8 weeks)