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

NCT ID: NCT00624559

Last Updated: 2012-01-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-01-31

Brief Summary

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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

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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).

Group Type EXPERIMENTAL

celecoxib (Celebrex)

Intervention Type DRUG

Celecoxib (Celebrex) was administered at 100 mg, twice per day for each day of sodium diet

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).

Group Type EXPERIMENTAL

celecoxib (Celebrex)

Intervention Type DRUG

Celecoxib (Celebrex) was administered at 100 mg, twice per day for each day of sodium diet

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).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo pill taken twice per day on each day of the diet

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).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo pill taken twice per day on each day of the diet

Interventions

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celecoxib (Celebrex)

Celecoxib (Celebrex) was administered at 100 mg, twice per day for each day of sodium diet

Intervention Type DRUG

Placebo

Placebo pill taken twice per day on each day of the diet

Intervention Type OTHER

Other Intervention Names

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Celebrex

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Christiana Care Health Services

OTHER

Sponsor Role collaborator

University of Delaware

OTHER

Sponsor Role lead

Responsible Party

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William Farquhar

Associate Professor and Department Chair, KAAP

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William B Farquhar, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Delaware

Michael Stillabower, MD

Role: STUDY_DIRECTOR

Christiana Care Health Services

Locations

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University of Delaware

Newark, Delaware, United States

Site Status

Countries

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United States

Other Identifiers

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134024-1

Identifier Type: -

Identifier Source: org_study_id

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