NCT01071122已完成4 期
A Prospective, Open-label, Active-controlled, Randomized Study Comparing Nifedipine GITS Versus Valsartan Versus a Combination of Both on Central Blood Pressure in Inadequately Controlled Essential Hypertension.
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
- Bayer
- 入组人数
- 365
- 主要终点
- Central systolic blood pressure
研究概览
简要总结
To determine whether the combination of nifedipine GITS and valsartan is more effective in reducing central blood pressure than nifedipine GITS or valsartan alone, and to determine whether nifedipine GITS is comparable to valsartan
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Untreated grade 2 or grade 3 hypertension defined by mean diastolic blood pressure (BP) >/= 100 and/or mean systolic BP >/= 160mmHg without anti-hypertensive treatment or Treated grade 2 hypertension defined by mean diastolic BP >/= 100 and/or mean systolic BP >/=160mmHg with current diuretics and/or beta-blockers use for >/= 4 weeks
排除标准
- •Secondary form of hypertension
- •Mean systolic BP >/= 200mmHg and or mean diastolic BP >/= 120mmHg
- •Treated with other antihypertensive medication except diuretics or beta-blockers
- •Type 1 diabetes mellitus
- •Known cardiovascular disease including history of angina pectoris, heart failure, history of myocardial infarction or revascularization procedure, or cerebrovascular disease (including stroke and transient ischaemic attack) within the previous 12 months
- •Renal insufficiency defined as a serum creatinine: >/= 1.7 mg/dl
- •Pregnancy or not using contraceptive in childbearing aged women
- •Breast feeding women
- •Any disease or condition that in the opinion of the investigator may interfere with completion of the study
研究组 & 干预措施
Arm 1
Experimental
干预措施: Nifedipine (Adalat, BAYA1040) and Valsartan (Drug)
Arm 2
Active Comparator
干预措施: Nifedipine (Adalat, BAYA1040) (Drug)
Arm 3
Active Comparator
干预措施: Valsartan (Drug)
结局指标
主要结局
Central systolic blood pressure
时间窗: Week 8
次要结局
- Change in central systolic blood pressure(Week 4)
- Change in augmentation index and augmentation pressure(Week 4,8)
- Change in brachial systolic blood pressure and diastolic blood pressure(Week 4,8)
- Response rate(≥10 mmHg decrease of brachial SBP and ≥5mmHg decrease of brachial DBP)(Week 4,8)
- Control rate (≤140/90 mmHg, 130/80 mmHg for diabetes, of brachial BP(Week 4,8)
- Change in central diastolic blood pressure and pulse pressure(Week 4,8)
- Change in brachial pulse pressure(Week4,8)
研究者
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