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

Primary Purpose

Hypertension

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
celecoxib (Celebrex)
Placebo
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypertension focused on measuring Salt sensitivity of Blood Pressure

Eligibility Criteria

22 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Delaware

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Celebrex; Low sodium

Celebrex, High Sodium

Placebo, Low Sodium

Placebo, High Sodium

Arm Description

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).

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).

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 15, 2008
Last Updated
January 4, 2012
Sponsor
University of Delaware
Collaborators
Christiana Care Health Services
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1. Study Identification

Unique Protocol Identification Number
NCT00624559
Brief Title
The Role of COX-2 Inhibition in Salt Sensitivity of Blood Pressure
Official Title
COX-2 Regulation of Renal Sodium Handling in Blood Pressure Maintenance
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Delaware
Collaborators
Christiana Care Health Services

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Salt sensitivity of Blood Pressure

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Celebrex; Low sodium
Arm Type
Experimental
Arm Description
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).
Arm Title
Celebrex, High Sodium
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo, Low Sodium
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
Placebo, High Sodium
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
celecoxib (Celebrex)
Other Intervention Name(s)
Celebrex
Intervention Description
Celecoxib (Celebrex) was administered at 100 mg, twice per day for each day of sodium diet
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo pill taken twice per day on each day of the diet
Primary Outcome Measure Information:
Title
Mean Arterial Pressure
Description
Blood pressure was measured on the last day of each 7 day sodium diet for 24 hours using an ambulatory blood pressure monitor
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Urinary Sodium Excretion
Description
Urine collected over 24 hour period on last day of each different sodium diet
Time Frame
24 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William B Farquhar, PhD
Organizational Affiliation
University of Delaware
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Stillabower, MD
Organizational Affiliation
Christiana Care Health Services
Official's Role
Study Director
Facility Information:
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19716
Country
United States

12. IPD Sharing Statement

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

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