Hypertension and Coronary Artery DiseasePhase 4NCT00471341
Effect of Celecoxib on Markers of Vascular Inflammation
A Phase 4 study testing Celecoxib in people with Hypertension and Coronary Artery Disease, run by University of Florida at 2 sites in United States.
Trial summary
This study involves a drug called celecoxib, which is commonly prescribed for people with arthritis. Arthritis is caused by inflammation of the joints or tissues. Inflammation also occurs in the blood vessels that lead to your heart, and the purpose of this study is to see if celecoxib can reduce the blood vessel… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hypertension and Coronary Artery Disease
- What is being tested?
- Celecoxib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2002to Dec 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 50 years old
- Hypertension documented and treated according to the 6th report of the Joint National Committee on Detection and Evaluation of the treatment of high blood pressure (JNC VI)
- Documented coronary artery disease, defined as classic stable angina pectoris, previous myocardial infarction (more than 1 month ago) or unstable angina (more than 1 month ago), abnormal coronary angiogram, or concordant abnormalities on two different types of stress tests
- Dyslipidemia requiring medical therapy with HMG CoA Reductase inhibitors, and treated according to NCEP II guidelines for cholesterol lowering
- Diabetes, if treated according to ADA guidelines for diabetes
- Classic angina, if treated according to ACC/AHA guidelines for angina control
- Therapy with an HMG CoA Reductase inhibitor for at least 3 months
- Willingness to provide informed consent
Who cannot join
- PUD
- Coronary Artery Bypass Surgery or PTCA in the past 6 months
- Active infection
- Weight < 50Kg
- History of a hematologic bleeding disorder
- History of gastrointestinal bleeding
Show all 15Show fewer
- Allergy to aspirin or celecoxib or other NSAIDs or sulfonamides
- Allergy or intolerance to HMG CoA Reductase inhibitor therapy
- Stroke within 1 month of enrollment
- History of a chronic inflammatory disease
- History of asthma
- History of hepatic disorder
- Advanced renal disease (Serum Creatinine > 3mg/dl)
- Anticipated need for therapy with NSAIDs within the 3 month period of the study
- Chronic therapy (14 consecutive days) with any NSAID in the last 30 days
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Florida
Gainesville, Florida, 32610
University of Texas Health Science Center
Houston, Texas
About this study
Official title: A Pilot Study to Determine the Effect of Celecoxib on Markers of Inflammation in Patients With Hypertension and Coronary Artery Disease
This study involves a drug called celecoxib, which is commonly prescribed for people with arthritis. Arthritis is caused by inflammation of the joints or tissues. Inflammation also occurs in the blood vessels that lead to your heart, and the purpose of this study is to see if celecoxib can reduce the blood vessel inflammation associated with high cholesterol and heart disease.
Read the detailed description
Chronic inflammation of the blood vessel wall is a hallmark of atherosclerosis. Elevated levels of low-density lipoprotein cholesterol (LDL-C), as well as blood pressure are known to be proinflammatory. Recent information suggests that acute ischemic events are associated with exacerbations in inflammation. Some data suggest that aspirin use is associated with suppression of markers of inflammation, and this response has been linked with improved outcome. Similarly, HMG Co-A Reductase inhibitors clearly reduce adverse outcomes in patients with atherosclerosis and recently, HMG Co-A Reductase inhibitor use has also been linked to reduction in inflammation. Due to the strong association of atherogenesis and plaque stability with inflammation, C-Reactive Protein (CRP), a marker of inflammation, has been evaluated as a potential tool for clinicians to assess cardiovascular risk, and has been found to be highly correlated. There is also evidence to suggest that cyclooxygenase 2 (COX-2) enzyme is expressed in plaque at regions which are vulnerable to rupture. Accordingly, this study is designed to investigate the potential reduction in vascular inflammation from a specific COX-2 inhibitor, celecoxib, as measured by a reduction from baseline of CRP, interleukin-6 (IL-6) and tumor necrosis factor - alpha (TNF-alpha). This is a double blind, placebo controlled pilot study in hypertensive patients with coronary artery disease and dyslipidemia, to evaluate the effect of celecoxib versus placebo on inflammatory markers. Patients will receive study drug for three months.
- Conditions
- Hypertension and Coronary Artery Disease
- Being tested
- Celecoxib, placebo
- Keywords
- arteriosclerosis, coronary disease, inflammation, COX-2 inhibition, hypertension
- Medical subject headings
- Hypertension, Coronary Artery Disease, Arteriosclerosis, Coronary Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
placeboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CRP
Secondary outcomes (4)
Change in IL6
Change in TNF alpha
Change in BP
Change in indices of vascular function (FMD and vascular compliance)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2007 (estimated)
- Study startJul 2002
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension and Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Rhonda M Cooper-DeHoff, Pharm D, Principal investigator, University of Florida Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00471341
- Sponsor's protocol ID
- 219-2001
- Status last verified
- May 2007
- First submitted
- 7 May 2007
- Last updated
- 19 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Effect of Celecoxib on Markers of Inflammation in Patients With Hypertension and Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00471341
- Acronym / sponsor ID
- 219-2001
- Conditions
- Hypertension and Coronary Artery Disease
- Keywords
- arteriosclerosis, coronary disease, inflammation, COX-2 inhibition, hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jul 2002
- Study completion
- Dec 2004 (actual)
- First posted
- 9 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study involves a drug called celecoxib, which is commonly prescribed for people with arthritis. Arthritis is caused by inflammation of the joints or tissues. Inflammation also occurs in the blood vessels that lead to your heart, and the purpose of this study is to see if celecoxib can reduce the blood vessel inflammation associated with high cholesterol and heart disease.
Detailed description
Chronic inflammation of the blood vessel wall is a hallmark of atherosclerosis. Elevated levels of low-density lipoprotein cholesterol (LDL-C), as well as blood pressure are known to be proinflammatory. Recent information suggests that acute ischemic events are associated with exacerbations in inflammation. Some data suggest that aspirin use is associated with suppression of markers of inflammation, and this response has been linked with improved outcome. Similarly, HMG Co-A Reductase inhibitors clearly reduce adverse outcomes in patients with atherosclerosis and recently, HMG Co-A Reductase inhibitor use has also been linked to reduction in inflammation. Due to the strong association of atherogenesis and plaque stability with inflammation, C-Reactive Protein (CRP), a marker of inflammation, has been evaluated as a potential tool for clinicians to assess cardiovascular risk, and has been found to be highly correlated. There is also evidence to suggest that cyclooxygenase 2 (COX-2) enzyme is expressed in plaque at regions which are vulnerable to rupture. Accordingly, this study is designed to investigate the potential reduction in vascular inflammation from a specific COX-2 inhibitor, celecoxib, as measured by a reduction from baseline of CRP, interleukin-6 (IL-6) and tumor necrosis factor - alpha (TNF-alpha). This is a double blind, placebo controlled pilot study in hypertensive patients with coronary artery disease and dyslipidemia, to evaluate the effect of celecoxib versus placebo on inflammatory markers. Patients will receive study drug for three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age greater than or equal to 50 years old
- Hypertension documented and treated according to the 6th report of the Joint National Committee on Detection and Evaluation of the treatment of high blood pressure (JNC VI)
- Documented coronary artery disease, defined as classic stable angina pectoris, previous myocardial infarction (more than 1 month ago) or unstable angina (more than 1 month ago), abnormal coronary angiogram, or concordant abnormalities on two different types of stress tests
- Dyslipidemia requiring medical therapy with HMG CoA Reductase inhibitors, and treated according to NCEP II guidelines for cholesterol lowering
- Diabetes, if treated according to ADA guidelines for diabetes
Key exclusion criteria (15 listed)
- PUD
- Coronary Artery Bypass Surgery or PTCA in the past 6 months
- Active infection
- Weight < 50Kg
- History of a hematologic bleeding disorder
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 | Drug | – |
| placebo | Drug | – |
Primary outcome
Change in CRP
4 secondary outcomes
Change in IL6
Change in TNF alpha
Change in BP
Change in indices of vascular function (FMD and vascular compliance)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2011.
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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.
Rhonda M Cooper-DeHoff, Pharm D principal investigator
University of Florida Faculty
2 sites 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 in people with Hypertension and Coronary Artery Disease, run by University of Florida at 2 sites 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 8 inclusion and 15 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 19 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in CRP. 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 19 Sep 2011.