HypertensionPhase 4NCT00624559
The Role of COX-2 Inhibition in Salt Sensitivity of Blood Pressure
A Phase 4 study testing celecoxib (Celebrex) in people with Hypertension, run by University of Delaware at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- celecoxib (Celebrex)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jan 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy men and women
Who cannot join
- history of heart disease
- have had heart surgery
- high blood pressure
- diabetes
- cancer
- any other disease such as kidney or neurological diseases
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: COX-2 Regulation of Renal Sodium Handling in Blood Pressure Maintenance
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- celecoxib (Celebrex), Placebo
- Keywords
- Salt sensitivity of Blood Pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celecoxib (Celebrex)Drug
Also called Celebrex
Celecoxib (Celebrex) was administered at 100 mg, twice per day for each day of sodium diet
PlaceboOther
Placebo pill taken twice per day on each day of the diet
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: 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). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Secondary outcomes (1)
Urinary Sodium Excretion
Urine collected over 24 hour period on last day of each different sodium diet
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- Christiana Care Health Services
- Responsible party
- Principal investigator, William Farquhar, University of Delaware
- Investigators
- William B Farquhar, PhD, Principal investigator, University of DelawareMichael Stillabower, MD, Study director, Christiana Care Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624559
- Sponsor's protocol ID
- 134024-1
- Status last verified
- Jan 2012
- First submitted
- 15 Feb 2008
- Last updated
- 6 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COX-2 Regulation of Renal Sodium Handling in Blood Pressure Maintenance
- ClinicalTrials.gov ID
- NCT00624559
- Acronym / sponsor ID
- 134024-1
- Conditions
- Hypertension
- Keywords
- Salt sensitivity of Blood Pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- Christiana Care Health Services
- Study start
- Feb 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 27 Feb 2008 (estimated)
- Results
- Posted 21 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Celebrex; Low sodium | Experimental | Drug: celecoxib (Celebrex)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). |
| Celebrex, High Sodium | Experimental | Drug: celecoxib (Celebrex)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). |
| Placebo, Low Sodium | Placebo comparator | Other: PlaceboSubject 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). |
| Placebo, High Sodium | Placebo comparator | Other: PlaceboSubject 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). |
Who may qualify
- Ages
- 22 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy men and women
Key exclusion criteria (12 listed)
- history of heart disease
- have had heart surgery
- high blood pressure
- diabetes
- cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| celecoxib (Celebrex)Also: CelebrexCelecoxib (Celebrex) was administered at 100 mg, twice per day for each day of sodium diet | Drug | Celebrex, High Sodium, Celebrex; Low sodium |
| PlaceboPlacebo pill taken twice per day on each day of the diet | Other | Placebo, High Sodium, Placebo, Low Sodium |
Primary outcome
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
1 secondary outcome
Urinary Sodium Excretion
Time frame: 24 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William B Farquhar, PhD principal investigator
University of Delaware
Michael Stillabower, MD study director
Christiana Care Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing celecoxib (Celebrex) in people with Hypertension, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Arterial Pressure (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2012.