NCT00857909已完成1 期
The Effect of Amiloride and Spironolactone Measured on Cardiovascular and Kidney Related Variables in Healthy Subjects in a Double-blinded, Randomised, Placebo-controlled, Cross-over Study
Regional Hospital Holstebro1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Blood pressure
研究概览
简要总结
This study will investigate whether retaining potassium in the body will lead to changes in blood pressure and changes in blood and urine samples.
详细描述
The purpose is to measure the effect of amiloride and spironolactone on:
- Renal function (GFR, u-AQP2, u-ENaCβ, u-cAMP, u-PGE2, CH20, FENa, FEK),
- Pulsbewave velocity, augmentation index and central blood pressure,
- Vasoactive hormones (PRC, AngII, Aldo, AVP, ANP, BNP and Endot), and
- Ambulatory blood pressure
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-smokers
排除标准
- •Under medical treatment
研究组 & 干预措施
Randomisation 2
Active Comparator
Spironolactone 25 mg twice daily, to be compared with placebo and amiloride
干预措施: Spironolactone (Drug)
Randomisation 1
Active Comparator
Amiloride 5 mg twice daily for 28 days, later compared with spironolactone and placebo
干预措施: Amiloride (Drug)
Randomisation 1
Active Comparator
Amiloride 5 mg twice daily for 28 days, later compared with spironolactone and placebo
干预措施: Placebo and spironolactone (Drug)
Placebo
Placebo Comparator
calcium tablet
干预措施: Placebo (Drug)
结局指标
主要结局
Blood pressure
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (1)
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