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

This study has been completed.
Sponsor:
Collaborator:
Christiana Care Health Services
Information provided by (Responsible Party):
William Farquhar, University of Delaware
ClinicalTrials.gov Identifier:
NCT00624559
First received: February 15, 2008
Last updated: January 4, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: celecoxib (Celebrex)
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: COX-2 Regulation of Renal Sodium Handling in Blood Pressure Maintenance

Resource links provided by NLM:


Further study details as provided by University of Delaware:

Primary Outcome Measures:
  • Mean Arterial Pressure [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 hour ] [ Designated as safety issue: No ]
    Urine collected over 24 hour period on last day of each different sodium diet


Enrollment: 12
Study Start Date: February 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   22 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624559

Locations
United States, Delaware
University of Delaware
Newark, Delaware, United States, 19716
Sponsors and Collaborators
University of Delaware
Christiana Care Health Services
Investigators
Principal Investigator: William B Farquhar, PhD University of Delaware
Study Director: Michael Stillabower, MD Christiana Care Health Services
  More Information

No publications provided

Responsible Party: William Farquhar, Associate Professor and Department Chair, KAAP, University of Delaware
ClinicalTrials.gov Identifier: NCT00624559     History of Changes
Other Study ID Numbers: 134024-1
Study First Received: February 15, 2008
Results First Received: August 17, 2011
Last Updated: January 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Delaware:
Salt sensitivity of Blood Pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014