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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: celecoxib (Celebrex); Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19716
      • University of Delaware

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Celebrex; Low sodium; 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).	Drug: celecoxib (Celebrex); Celecoxib (Celebrex) was administered at 100 mg, twice per day for each day of sodium diet; Other Names: Celebrex
Experimental: Celebrex, High Sodium; 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).	Drug: celecoxib (Celebrex); Celecoxib (Celebrex) was administered at 100 mg, twice per day for each day of sodium diet; Other Names: Celebrex
Placebo Comparator: Placebo, Low Sodium; 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).	Other: Placebo; Placebo pill taken twice per day on each day of the diet
Placebo Comparator: Placebo, High Sodium; 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).	Other: Placebo; Placebo pill taken twice per day on each day of the diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Arterial Pressure	Blood pressure was measured on the last day of each 7 day sodium diet for 24 hours using an ambulatory blood pressure monitor	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary Sodium Excretion	Urine collected over 24 hour period on last day of each different sodium diet	24 hour

Collaborators and Investigators

• Sponsor: University of Delaware
• Collaborators: Christiana Care Health Services
• Investigators: Principal Investigator: William B Farquhar, PhD, University of Delaware; Study Director: Michael Stillabower, MD, Christiana Care Health Services

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: February 15, 2008
• First Submitted That Met QC Criteria: February 15, 2008
• First Posted (Estimate): February 27, 2008

Study Record Updates

• Last Update Posted (Estimate): January 6, 2012
• Last Update Submitted That Met QC Criteria: January 4, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Salt sensitivity of Blood Pressure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib
• Other Study ID Numbers: 134024-1