NCT00136851已完成4 期
A 6-Week Multi-center, Randomized, Double-Blind, Parallel Group Study Comparing the Efficacy of Amlodipine Besylate/Benazepril Versus Amlodipine in the Treatment of Severe Hypertension
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 259
- 试验地点
- 2
- 主要终点
- Percentage of subjects achieving blood pressure goal which is defined as < 140/90 mm Hg, or < 130/80 mm Hg in subjects with diabetes after 4 weeks
研究概览
简要总结
This trial is designed to study the efficacy of an amlodipine besylate/benazepril treatment regimen versus an amlodipine treatment regimen in the treatment of severe 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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of severe hypertension
排除标准
- •Diastolic blood pressure (DBP) < 60 mm Hg
- •Serum potassium < 3.5 or > 5.5 mEq/L in the absence of all potassium supplements
- •Refractory hypertension defined as systolic blood pressure (SBP) ≥ 180 mmHg and/or DBP ≥ 110 mmHg and unresponsive to triple-drug regimens
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Percentage of subjects achieving blood pressure goal which is defined as < 140/90 mm Hg, or < 130/80 mm Hg in subjects with diabetes after 4 weeks
次要结局
- Percentage of subjects achieving blood pressure goal, defined as < 140/90 mm Hg, or < 130/80 mm Hg in subjects with diabetes after 6 weeks
- Change from baseline in the mean sitting systolic blood pressure after 4 and 6 weeks
- Change from baseline in the mean sitting diastolic blood pressure after 4 and 6 weeks
- Percentage of subjects with swelling in legs or arms after 4 and 6 weeks
研究者
研究点 (2)
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