NCT01070940已完成1 期
L-NMMA's Effect on Renal and Cardiovascular Variables in Healthy Subjects. A Randomized, Placebo-controlled Crossover Study.
Regional Hospital Holstebro1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2010年2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
- 12
- 试验地点
- 1
- 主要终点
- Systolic blood pressure
研究概览
简要总结
The purpose of this study is to investigate the effect of different levels of nitric oxide inhibition on blood pressure and arterial stiffness in healthy subjects. L-NMMA, an inhibitor of the nitric oxide synthase, is administered as bolus injection followed by continuous infusion, and is expected to raise blood pressure and arterial stiffness according to L-NMMA dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males
- •Age 18-35 years
- •BMI 18.5-30.0
排除标准
- •Tobacco or illicit drug use
- •Current use of any prescription or non-prescription drugs
- •Alcohol abuse
- •History of heart failure, lever failure, chronic kidney disease or cerebral insult
- •Clinical or paraclinical signs of infection
- •Pathologic ECG
- •Ambulatory blood pressure >140/90 mmHg
- •Abnormal blood or urin screening tests
研究组 & 干预措施
Isotonic saline infusion
Placebo Comparator
干预措施: Placebo (Drug)
Intravenous L-NMMA dose 2
Active Comparator
干预措施: NG-monomethyl-L-arginine (L-NMMA) (Drug)
Intravenous L-NMMA dose 3
Active Comparator
干预措施: NG-monomethyl-L-arginine (L-NMMA) (Drug)
Intravenous L-NMMA dose 1
Active Comparator
干预措施: NG-monomethyl-L-arginine (L-NMMA) (Drug)
结局指标
主要结局
Systolic blood pressure
时间窗: 6 hours
次要结局
- GFR(6 hours)
- Arterial Stiffness(6 hours)
- Fractional excretion of sodium(6 hours)
- Fractional excretion of potassium(6 hours)
- Plasma renin concentration(6 hour)
- Plasma angiotensin II(6 hours)
- Plasma aldosterone(6 hour)
研究者
研究点 (1)
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