NCT01048047Unknown4 期
Effects of Aliskiren/Amlodipine Versus Amlodipine Monotherapy on Ankle-foot Volume in Hypertensive Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Blood pressure, heart rate, ankle-foot volume
研究概览
简要总结
Comparison between the effect of aliskiren/amlodipine combination with amlodipine monotherapy on ankle-foot volume in hypertensive patients. It will be enrolled male or female outpatients, aged 18-65 years.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diastolic blood pressure > 95 mmHg and < 110 mmHg
- •systolic blood pressure > 140 mmHg and < 180 mmHg
- •no amlodipine therapy for the previous 6 months
排除标准
- •diastolic blood pressure > 110 mmHg and or
- •systolic blood pressure > 180 mmHg
- •secondary hypertension
- •heart failure
- •diabetes mellitus
- •liver or kidney diseases
研究组 & 干预措施
aliskiren/amlodipine
Experimental
aliskiren, 300 mg/amlodipine 10 mg
干预措施: aliskiren/amlodipine (Drug)
amlodipine
Active Comparator
amlodipine 10 mg
干预措施: aliskiren/amlodipine (Drug)
结局指标
主要结局
Blood pressure, heart rate, ankle-foot volume
时间窗: At baseline, at the end of the wash-out period, after 2, 4, and 8 weeks
次要结局
- Blood pressure and heart rate in sitting and standing position(At baseline, at the end of the wash-out period, after 2, 4, and 8 weeks)
研究者
研究点 (1)
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