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

• ClinicalTrials.gov Identifier: NCT00624559
• Recruitment Status: Completed
• First Posted: February 27, 2008
• Results First Posted: December 21, 2011
• Last Update Posted: January 6, 2012
• Sponsor: University of Delaware
• Collaborator: Christiana Care Health Services
• Information provided by (Responsible Party): William Farquhar, University of Delaware

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.

Condition or disease	Intervention/treatment	Phase
Hypertension	Drug: celecoxib (Celebrex); Other: Placebo	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: COX-2 Regulation of Renal Sodium Handling in Blood Pressure Maintenance
• Study Start Date: February 2008
• Actual Primary Completion Date: January 2009
• Actual Study Completion Date: January 2009

Arms and Interventions

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 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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

1. Urinary Sodium Excretion [ Time Frame: 24 hour ]
   Urine collected over 24 hour period on last day of each different sodium diet

Eligibility Criteria

• Ages Eligible for Study: 22 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: William Farquhar, Associate Professor and Department Chair, KAAP, University of Delaware
• ClinicalTrials.gov Identifier: NCT00624559
• Other Study ID Numbers: 134024-1
• First Posted: February 27, 2008
• Results First Posted: December 21, 2011
• Last Update Posted: January 6, 2012
• Last Verified: January 2012

Keywords provided by William Farquhar, University of Delaware:

Salt sensitivity of Blood Pressure

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases; Celecoxib; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase 2 Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action