NCT01287260已完成3 期
A Multicenter, Double-blind, Parallel-group Comparative Study Between Oral BAYA1040_CR 80 mg and 40 mg for 8 Weeks in Patients With Essential Hypertension for Whom Oral BAYA1040_CR 40 mg is Insufficient
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 352
- 主要终点
- Efficacy changes measured by sitting diastolic blood pressure (DBP)
研究概览
简要总结
This is a clinical study evaluating the superiority in efficacy and assess safety and tolerability of BAYA1040_Nifedipine 80 mg/day (40 mg twice daily) compared with BAYA1040_Nifedipine 40 mg/day (40 mg once daily) in patients with essential hypertension who are not at target blood pressure by BAYA1040_Nifedipine 40 mg once daily treatment.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 years or older
- •Japanese male or female
- •Outpatient with essential hypertension
- •Patients whose sitting diastolic blood pressure (DBP) is 90 mmHg or more despite more than 4 weeks of treatment with antihypertensive drug
排除标准
- •Sitting diastolic blood pressure (DBP) is 110 mmHg or more or sitting systolic blood pressure (SBP) is 180 mmHg or more
- •Patients with secondary hypertension or hypertensive emergency
研究组 & 干预措施
Arm1
Experimental
干预措施: Nifedipine (Adalat, BAYA1040) (Drug)
Arm 2
Active Comparator
干预措施: Nifedipine (Adalat, BAYA1040) (Drug)
结局指标
主要结局
Efficacy changes measured by sitting diastolic blood pressure (DBP)
时间窗: Up to 8 weeks
次要结局
- Efficacy changes measured by sitting systolic blood pressure (SBP)(Up to 8 weeks)
- Achievement rate: Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines(Up to 8 weeks)
- Responder rate: Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP(Up to 8 weeks)
研究者
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