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

University of Delaware

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Other: Placebo; Drug: celecoxib (Celebrex)

Study type: Interventional

Funder types: Other

Identifiers

NCT00624559

134024-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 22 to 50 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 4 patient groups, including a placebo group

Celebrex; Low sodium

Experimental group

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).

Treatment:

Drug: celecoxib (Celebrex)

Celebrex, High Sodium

Experimental group

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).

Treatment:

Drug: celecoxib (Celebrex)

Placebo, Low Sodium

Placebo Comparator group

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).

Treatment:

Other: Placebo

Placebo, High Sodium

Placebo Comparator group

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).

Treatment:

Other: Placebo