Coronary Artery Disease - PRECISION
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Trial Sponsor
Pfizer Inc.
Principal Investigator
Holly Novak, MD
Trial Name
A Randomized, Double Blind, Parallel-Group Study Of Cardiovascular Safety In Osteoarthritis Or Rheumatoid Arthritis Patients With Or At High Risk For Cardiovascular Disease Comparing Celecoxib With Naproxen And Ibuprofen
Purpose
The purpose of this trial is to answer the question of overall benefit versus the risk of taking celecoxib (Celebrex) when compared to Naproxen (Aleve) and Ibuprofen, two of the most commonly prescribed traditional (non-selective) nonsteroidal anti-inflammatory drugs (NSAIDs), in the treatment of arthritis pain. For this purpose, patients with osteoarthritis or rheumatoid arthritis with or at risk of developing cardiovascular (heart) disease will be recruited. The cardiovascular (heart), gastrointestinal (stomach) and renal (kidney) safety and symptomatic benefit in each treatment group will be assessed accordingly.
Ages eligible for the study
18 years or older
Genders eligible for the study
Both
Inclusion Criteria
- Subjects with osteoarthritis or rheumatoid Arthritis with or at risk of developing heart disease and who require and are eligible for chronic, daily therapy with an NSAID to control arthritis signs and symptoms.
Exclusion Criteria
- Subjects that have had a recent cardiovascular (heart) event, unstable cardiovascular conditions, or any major surgery (cardiac or non-cardiac) within 3 months prior to randomization;
- Subjects with medical or laboratory abnormalities that would make the subject inappropriate for entry into this trial
- Subjects that require treatment with more than 325 mg of aspirin daily
- Subjects with known hypersensitivity (reactions) to celecoxib, ibuprofen, naproxen, aspirin or esomeprazole (Nexium), etc.
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