NCT00518765已完成3 期
A Single-center, Placebo-controlled Study of the Effects of Ascending Single Oral Doses of Aliskiren Compared With Captopril on Renal Hemodynamics in Healthy Volunteers on a Low and High Sodium Diet "Renin Inhibition and the Kidney"
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
- Novartis
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Renal plasma flow following 3 single doses of aliskiren in healthy volunteers on a low sodium(10 mEq/day)diet
研究概览
简要总结
This study will measure the effects of different doses of aliskiren on kidney blood flow and function in healthy adults and determine how salt intake affects the response to aliskiren.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects age 18 to 75 years of age included
- •Strictly adhere to provided diet.
排除标准
- •Symptomatic low blood pressure
- •Prescription medications, including those for blood pressure control, birth control pills, and any other medication that could affect kidney function
- •Over-the-counter medication 2 weeks before study start
- •Clinically significant heart abnormalities.
- •Previous history of allergy to the study drug or drugs similar to the study drug.
- •Any surgical or medical condition which might significantly alter the action of a drug (for example, absorption, distribution, metabolism or excretion) or which may jeopardize the subject in case of participation in the study.
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
1
Experimental
Various sequences of different doses of Aliskiren
干预措施: Aliskiren (Drug)
2
Experimental
Various sequences of different doses of Aliskiren plus placebo
干预措施: Aliskiren plus placebo (Drug)
3
Experimental
Various sequences of different doses of Aliskiren
干预措施: Aliskiren (Drug)
4
Experimental
Various sequences of different doses of Aliskiren plus placebo
干预措施: Aliskiren plus placebo (Drug)
结局指标
主要结局
Renal plasma flow following 3 single doses of aliskiren in healthy volunteers on a low sodium(10 mEq/day)diet
时间窗: baseline and hourly intervals.
次要结局
- Single dose application of aliskiren on renal hemodynamics and circulating markers of the renin pathway(baseline, and at 5 hours, and 24 hours post dose)
研究者
研究点 (1)
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