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. Author manuscript; available in PMC: 2010 Oct 28.
Published in final edited form as: Circulation. 2008 Mar 31;117(16):2104–2113. doi: 10.1161/CIRCULATIONAHA.108.764530

Table 1. Description of Each Study in the Cross Trial Safety Analysis.

Study Sponsor Description Randomization/Dose Stratification Planned Follow-Up Time
APC NCI and Pfizer Comparison of 2 doses of celecoxib with placebo for the prevention of colorectal adenoma recurrence Celecoxib 200 mg BID, celecoxib 400 mg BID, or placebo Center; low-dose aspirin use 37 mo
PreSAP Pfizer Comparison of celecoxib with placebo for the prevention of colorectal adenoma recurrence Celecoxib 400 mg QD or placebo Country; low-dose aspirin use 37 mo
MA27 NCI, NCI of Canada, and Pfizer Factorial design comparing 2 aromatase inhibitors with or without celecoxib in postmenopausal women with breast cancer Factorial design: exemestane (2.5 mg/d) or anastrozole (1 mg/d); celecoxib (400 mg BID) or placebo Lymph node status at diagnosis; adjuvant chemotherapy; low-dose aspirin use Participants would take celecoxib for 3 y after randomization but were to be followed up until the study end, which was the time of ending treatment with aromatase inhibitor
ADAPT NIA Comparison of naproxen sodium, celecoxib, and placebo for the prevention of Alzheimer's disease and attenuation of age-related cognitive decline Naproxen sodium (220 mg BID), celecoxib (200 mg BID), or placebo Field site; age categories: 70–74 y, 75–79 y, ≥80 y Up to 7 y
CDME NEI Factorial design comparing laser diode photocoagulation to focal photocoagulation and celecoxib or placebo for 3 months before and after laser coagulation Celecoxib (200 mg BID) or placebo None 3 y
Celecoxib/Selenium Trial NCI Factorial design study comparing celecoxib with placebo and selenium with placebo for the prevention of colonic polyp recurrence Factorial design: celecoxib (400 mg QD) or placebo; selenium (200 μg/d) or placebo Clinical center; low-dose aspirin use 3 to 5 y after randomization; the planned length of follow-up depended on the recommendation by the participant's gastrointestinal physician for a follow-up colonoscopy

NIA indicates National Institute on Aging.