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

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: celecoxib (Celebrex); Other: Placebo

• Registration Number: NCT00624559
• Lead Sponsor: University of Delaware

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-15
• Study First Submitted QC: 2008-02-15
• Study First Posted: 2008-02-27
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Results First Submitted: 2011-08-17
• Results First Submitted QC: 2011-11-16
• Results First Posted: 2011-12-21
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-04
• Last Update Posted: 2012-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Celebrex; Low sodium	celecoxib (Celebrex)	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).
Celebrex, High Sodium	celecoxib (Celebrex)	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).
Placebo, Low Sodium	Placebo	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).
Placebo, High Sodium	Placebo	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).

Primary Outcome Measures

Name	Time	Method
Mean Arterial Pressure	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 Outcome Measures

Name	Time	Method
Urinary Sodium Excretion	24 hour	Urine collected over 24 hour period on last day of each different sodium diet

Trial Locations

Locations (1)

University of Delaware; 🇺🇸 Newark, Delaware, United States