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Biostatistics and Medical Informatics
Clinical Trials Program Statistical Data Analysis Center
Research Portfolio - Completed Trials, Ongoing Publications

REDHF Trial (2006 - 2013) A phase 3, double-blind, randomized, placebo-controlled, multicenter study to assess the efficacy and safety of darbepoetin alfa treatment on mortality and morbidity in heart failure (HF) subjects with symptomatic left ventricular systolic dysfunction and anemia. Primary endpoint was time to death from any cause or first hospital admission for worsening HF, whichever occurred first. Industry sponsored.

 
Swedberg K, Young JB, Anand IS, Cheng S, Desai AS, Diaz R, Maggionia AP, McMurray JJV, O’Connor C, Pfeffer MA, Solomon SD, Sun Y, Tnedera M, van Veldhuisen DJ, for the RED-HF Committees and Investigators. Treatment of anemia with darbepoetin alfa in systolic heart failure. The New England Journal of Medicine electronic publication, March 10, 2013.
 

A8851009 (2007-2011) A phase 3 prospective, randomized trial comparing the efficacy of anidulafungin and voriconazole in combination to that of voriconazole alone when used for primary therapy of proven or probable invasive aspergillosis (IA). The primary endpoint was all cause mortality, measured 6 weeks after IA initiation of study drug subjects with proven or probable IA.

 

I-PRESERVE (2002-2008) Approximately 4128 patients with advanced heart failure and with preserved systolic function from North America and Europe. Randomized, double-blind, multicenter clinical trial. Comparison of Irbesartan, an angiotensin II receptor antagonist, versus placebo. Primary endpoint is all cause mortality or cardiovascular morbidity Industry sponsored.

 
Massie B, Carson PE, McMurray JJ, Komajda M, McKelvie R, Zile MR, Anderson S, Donovan M, Iverson E, Staiger C, Praszynska A, I-PRESERVE Investigators. Irbesartan in patients with heart failure and preserved ejection fraction. The New England Journal of Medicine 359 (23):2456-67, 2008.
 

EVEREST (2003-2007) 4133 patients with worsening congestive heart failure (CHF). Randomized, multicenter, double-blind clinical trial. Comparison of tolvaptan, vasopressin receptor antagonist, in conjunction with optimal current therapy on the time to all-cause mortality, versus placebo. Primary outcomes are all cause mortality, cardiovascular mortality or CHF morbidity and global clinical status. Industry sponsored.

 
Konstam MA, Gheorghiade M, Burnett JC Jr., Grinfeld L, Maggioni AP, Swedberg K, Udelson JE, Zannad F, Cook T, Ouyang J, Zimmer C, Orlandi C. Effects of oral tolvaptan in patients hospitalized for worsening heart failure. Journal of the American Medical Association 297(12): 1319-1331, 2007.

Gheorghiade M, Konstam MA, Burnett JC Jr., Grinfeld L, Maggioni AP, Swedberg K, Udelson JE, Zannad F, Cook T, Ouyang J, Zimmer C, Orlandi C. Short-term clinical effects of tolvaptan, an oral vasopressin antagonist, in patients hospitalized for heart failure. Journal of the American Medical Association 297(12): 1331-1343, 2007.
 

ILLUMINATE (2004-2006) 15,067 patients from 250 sites in North America, Europe and Australia. A multi-center, double-blind, randomized, parallel group evaluation of the fixed combination torcetrapib/atorvastatin, administered orally, once daily, compared with atorvastatin alone, on the occurrence of major cardiovascular events in subjects with coronary heart disease or risk equivalents. Industry sponsored.  Results presented at the November 2007 American Heart Association meeting.

 
Barter PJ, Caulfield M, Eriksson M, Grundy SM, Kastelein JP, Komajda M, Lopez-Sendon J, Mosca L, Tardif J, Waters DD, Shear Cl, Revkin JH, Buhr KA, Fisher MR, Tall AR, Brewer B, for the ILLUMINATE Investigators. Effects of torcetrapib in patients at high risk for coronary events.
The New England Journal of Medicine 357 (21):2109-22, 2007.

 

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. The New England Journal of Medicine 352:1425-35, 2005.

 

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.

 
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Selected Ongoing Trials | Completed Trials, Ongoing Publications
 
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