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临床试验/NCT00624559
NCT00624559已完成4 期

COX-2 Regulation of Renal Sodium Handling in Blood Pressure Maintenance

University of Delaware1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2008年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
12
试验地点
1
主要终点
Mean Arterial Pressure

研究概览

简要总结

The purpose of this study is to determine if the drug Celebrex changes the way the kidney gets rid of salt and maintains blood pressure.

详细描述

There have been many studies done with analgesics such as acetaminophen and non-steroidal anti-inflammatory drugs; however it is not understood how blood pressure changes while using Celebrex. The study hypothesis is that Celebrex will increase salt sensitivity of 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
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
22 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • healthy men and women

排除标准

  • history of heart disease
  • have had heart surgery
  • high blood pressure
  • any other disease such as kidney or neurological diseases
  • taking medications such as aspirin or medicines for your heart or blood pressure
  • have asthma or are allergic to sulfa drugs
  • body mass index greater than 30
  • use tobacco
  • women using oral contraceptives or hormone replacement therapy

研究组 & 干预措施

Celebrex; Low sodium

Experimental

Subject completes a normal sodium diet (3 days), a low salt diet (7 days), followed by a high salt diet (7 days) while taking a celebrex pill (100 mg twice a day for 17 day trial), randomized for trial order (drug versus placebo) and sodium diet order (low versus high sodium).

干预措施: celecoxib (Celebrex) (Drug)

Celebrex, High Sodium

Experimental

Subject completes a normal sodium diet (3 days), a high salt diet (7 days), followed by a low salt diet (7 days) while taking a celebrex pill (100 mg twice a day for 17 day trial), randomized for trial order (drug versus placebo) and sodium diet order (low versus high sodium).

干预措施: celecoxib (Celebrex) (Drug)

Placebo, Low Sodium

Placebo Comparator

Subject completes a normal sodium diet (3 days), a low salt diet (7 days), followed by a high salt diet (7 days) while taking a placebo pill (twice a day for 17 day trial), randomized for trial order (drug versus placebo) and sodium diet order (low versus high sodium).

干预措施: Placebo (Other)

Placebo, High Sodium

Placebo Comparator

Subject completes a normal sodium diet (3 days), a high salt diet (7 days), followed by a low salt diet (7 days) while taking a placebo pill (twice a day for 17 day trial), randomized for trial order (drug versus placebo) and sodium diet order (low versus high sodium).

干预措施: Placebo (Other)

结局指标

主要结局

Mean Arterial Pressure

时间窗: 24 hours

Blood pressure was measured on the last day of each 7 day sodium diet for 24 hours using an ambulatory blood pressure monitor

次要结局

  • Urinary Sodium Excretion(24 hour)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

William Farquhar

Associate Professor and Department Chair, KAAP

University of Delaware

研究点 (1)

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