NCT00624559

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 27, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
3 years until next milestone

Results Posted

Study results publicly available

December 21, 2011

Completed
Last Updated

January 6, 2012

Status Verified

January 1, 2012

Enrollment Period

11 months

First QC Date

February 15, 2008

Results QC Date

August 17, 2011

Last Update Submit

January 4, 2012

Conditions

Hypertension

Keywords

Salt sensitivity of Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • 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

    24 hours

Secondary Outcomes (1)

  • Urinary Sodium Excretion

    24 hour

Study Arms (4)

Celebrex; Low sodium

EXPERIMENTAL

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)

Celebrex, High Sodium

EXPERIMENTAL

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)

Placebo, Low Sodium

PLACEBO COMPARATOR

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, High Sodium

PLACEBO COMPARATOR

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

Interventions

celecoxib (Celebrex)DRUG

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

Also known as: Celebrex
Celebrex, High SodiumCelebrex; Low sodium
PlaceboOTHER

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

Placebo, High SodiumPlacebo, Low Sodium

Eligibility Criteria

Age22 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy men and women

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Delaware

Newark, Delaware, 19716, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. William Farquhar
Organization
University of Delaware
wbf@udel.edu
302-831-6178

Study Officials

  • William B Farquhar, PhD

    University of Delaware

    PRINCIPAL INVESTIGATOR

  • Michael Stillabower, MD

    Christiana Care Health Services

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Department Chair, KAAP

Study Record Dates

First Submitted

February 15, 2008

First Posted

February 27, 2008

Study Start

February 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

January 6, 2012

Results First Posted

December 21, 2011

Record last verified: 2012-01

Locations

US(1)