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Completed

NCT Number: NCT00624559

The Role of COX-2 Inhibition in Salt Sensitivity of Blood Pressure

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

22 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Delaware

Newark, Delaware, 19716, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy men and women

Exclusion criteria

  • history of heart disease
  • have had heart surgery
  • high blood pressure
  • diabetes
  • cancer
  • 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
  • pregnant
  • women using oral contraceptives or hormone replacement therapy

Treatment and study plan

celecoxib (Celebrex)

Drug

Celecoxib (Celebrex) was administered at 100 mg, twice per day for each day of sodium diet

Other names: Celebrex

Placebo

Other

Placebo pill taken twice per day on each day of the diet

Primary outcomes

  1. Mean Arterial Pressure

    Time frame: 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

Secondary outcomes

  1. Urinary Sodium Excretion

    Time frame: 24 hour

    Urine collected over 24 hour period on last day of each different sodium diet

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Collaborators

  • Christiana Care Health Services

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 27, 2008
Registry last updated
Jan 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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