NCT00856960已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, 4-Treatment, 3-Period, Incomplete Block, Balanced Crossover Study to Evaluate the Effects of a Single Dose of Aliskiren and Losartan on Renal Blood Flow Measurements in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Aliskiren
研究概览
简要总结
This study will evaluate the effect of Aliskiren and Losartan on renal blood flow using PAH clearance, PC MRA and ASL MRI methodologies.
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 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject is in generally good health
- •Subject is willing to avoid unaccustomed strenuous exercise during the study
- •Subject agrees to consume ONLY the study-specified diet during all domiciled periods
- •Subject has been a non-smoker for at least 3 months prior to study
- •Subject will refrain from smoking or using any tobacco products during the study
- •Subject agrees to refrain from consuming alcohol or caffeine during the domiciled periods and agrees to limit alcohol and caffeine consumption throughout the study
排除标准
- •Subject has contraindication to MRI scans
- •Subject has a history of stroke, seizure, or major neurological disorders
- •Subject uses illicit drugs or has a history of drug/alcohol abuse
- •Subject has had major surgery, has donated or lost 1 unit of blood, or has been in another investigational study in the last 4 weeks
- •Subject has a history of multiple and/or severe allergies to drugs or food
研究组 & 干预措施
1
Active Comparator
Aliskiren 600 mg
干预措施: Aliskiren (Drug)
2
Active Comparator
Aliskiren 150 mg
干预措施: Aliskiren (Drug)
结局指标
主要结局
change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Aliskiren
时间窗: 2-5 hours post dose of study drug
次要结局
- change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Losartan(2-5 hours post dose of study drug)
研究者
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