Biostatistics and Medical Informatics
Clinical Trials Program Statistical Data Analysis Center
Research Portfolio - Completed Trials, Ongoing Publications
ADOPT (2000-2006) 4379 patients with recently diagnosed type 2 diabetes mellitus who are drug naive from North America and Europe at 471 centers. Randomized, double-blind clinical trial. Comparison of Avandia, rosiglitazone, monotherapy to metformin or glyburide/glibenclamide monotherapy. Primary outcome was monotherapy failure. Industry sponsored.
Kahn, SE, Haffner SM, Heise MA, Herman WH, Holman RR, Jones NP, Kravitz BG, Lachin JM, O'Neill C, Zinman B, Viberti G for the ADOPT Study Group. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. New England Journal of Medicine 355(23):2427-53, 2006.
CSMS 802 & 804 (1999-2006) 890 patients with diabetic retinopathy in two trials in North America and Europe at 96 centers. Randomized, double-blind clinical trial. Comparison of Sandostatin LAR Depot, octreotide acetate for injectable suspension approved for long-term maintenance therapy in acromegalic patients, versus placebo. Primary outcome was progression of retinopathy. Industry sponsored.
TNT (2000-2004) 10,003 patients with clinically evident coronary heart disease (CHD) from 14 countries at 242 centers. Randomized double-blind clinical trial. Comparison of Lipitor, atorvastatin, in lowering low density lipoprotein cholesterol (LDL-C) to achieve LDL-C targets beyond currently recommended target (goal is 75 mg/dL) when compared to only achieving the minimum target (goal is 100 mg/dL). Primary outcome was major CHD event defined as either CHD death or non-fatal myocardial infarction. Results presented at March 2005 American College of Cardiology Late-Breaking Trials.
LaRosa, JC, Grundy SM, Waters DD, Shear C, Barter P, Fruchart JC, Gotto AM, Greten H, Kastelein JJ, Shepherd J, Wenger NK for the Treating to New Targets Investigators. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. New England Journal of Medicine. 352:1425-35, 2005.
ESSENTIAL (2001-2004) 1854 patients with advanced heart failure in two trials. Randomized, double-blind, multicenter clinical trial. Comparison of Enoximone, a type-III phosphodiesterase inhibitor, versus placebo. Primary outcome was all cause mortality or cardiovascular hospitalization. Industry sponsored.
WIZARD (1997-2001) 7747 post MI patients exposed to C. pneumoniae from North and South America, Europe, and India at 271 centers. Randomized, double-blind clinical trial. Comparsion of Azithromax, an anti-infective agent agent, versus placebo. Primary outcome was progression of clinical coronary artery disease. Industry sponsored. Results presented at March 2002 American College of Cardiology Late-Breaking Trials.
O'Connor CM, Dunne MW, Pfeffer MA, Muhlestein JB, Yao L, Gupta S, Benner RJ, Fisher MR, Cook TD. Azithromycin for the secondary prevention of coronary hearth disease events. Journal of the American Medical Association 290:1459-1466, 2003.
Aguilar D, Fisher MR, O'Connor CM, Dunne MW, Muhlestein JB, Yao L, Gupta S, Benner RJ, Cook TD, Edwards D, Pfeffer MA. Metabolic syndrome, C-reactive protein, and prognosis in patients with established coronary artery disease. American Heart Journal 152(2):298-304, 2006.
This list was last updated
January 8, 2007
and is in reverse chronology by end date.
