Effect of Celecoxib on Markers of Vascular Inflammation

NCT00471341 | Completed Phase 4

• 1 other identifier: 219-2001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

Brief 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 inflammation associated with high cholesterol and heart disease.

Conditions

Hypertension and Coronary Artery Disease

Keywords

arteriosclerosis; coronary disease; inflammation; COX-2 inhibition; hypertension

Outcome Measures

Primary Outcomes (1)

• 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)

Interventions

Celecoxib DRUG

placebo DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Florida: lead
• Pfizer: collaborator

Study Sites (2)

University of Florida

Gainesville, Florida, 32610, United States

Location

University of Texas Health Science Center

Houston, Texas, United States

Location

MeSH Terms

Conditions

Hypertension; Coronary Artery Disease; Arteriosclerosis; Coronary Disease; Inflammation

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases; Arterial Occlusive Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Rhonda M Cooper-DeHoff, Pharm D

  University of Florida Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2007
• First Posted: May 9, 2007
• Study Start: July 1, 2002
• Study Completion: December 1, 2004
• Last Updated: September 19, 2011

Record last verified: 2007-05

Locations

US (2)