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Robin Bechhofer
Programmer Analyst, Department of Biostatistics & Medical Informatics

 

BA, 1976, Harvard University

 

  220A WARF Office Building
610 Walnut Street
Madison, WI 53726-2397
     
  Phone: 608-263-3179
Fax: 608-263-0415
E-mail:bechhof@biostat.wisc.edu

Clinical Trials Involvement

Ongoing Trials
 

TREAT (2004-present) Approximately 4000 patients from 700 sites in North America, Europe and Australia. A randomized, double-blind, multicenter study to assess the effect of anemia therapy with darbepoetin alfa on the composite event comprising all-cause mortality and cardiovascular (CV) events in subjects with both chronic kidney disease (CKD) and Type 2 diabetes mellitus (DM). Industry sponsored.

 

 

EVEREST (2003-present) Approximately 3600 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.

 

Completed Trials and Ongoing Publications
 

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 is major CHD event defined as either CHD death or non-fatal myocardial infarction.

 

   

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

 

 

SPORTIF III and V (2000-2004) Approximately 6000 patients with atrial fibrillation in two trials (3000 from USA and Canada in double-blind trial; 3000 from 25 other countries in open label trial). Randomized clinical trial. Comparison of Exanta, an oral direct thrombin inhibitor, versus dose-adjusted warfarin. Primary outcome is stroke and systemic embolic events. Industry sponsored. Results from SPORTIF III were presented at April 2003 American College of Cardiology Late-Breaking Trials.

 

   

Executive Steering Committee on behalf of the SPORTIF III Investigators. Stroke prevention with the oral direct thrombin inhibitor ximelagatran compared with warfarin in patients with non-valvular atrial fibrillation (SPORTIF III): randomized controlled trial. The Lancet 362: 1691-98, 2003

 

   

Executive Steering Committee for the SPORTIF V Investigators. Ximelagatran vs warfarin for stroke prevention in patients with nonvalvular atrial fibrillation; a randomized trial. Journal of the American Medical Association 293:690-98, 2005.

 

Completed Trials and Publications
 

EXCITE (1997-1999) 7232 patients undergoing PTCA or stent placement from the Americas, Europe, Australia, New Zealand, Israel, and South Africa in 412 centers. Randomized double-blind trial. Comparison of Xemilofiban, an oral anti-platelet agent, versus placebo. Primary outcome was occurrence of death, MI, or urgent revascularization at 6 months. Industry sponsored. Results presented at March 1999 American College of Cardiology Meeting.

 

   

O'Neil W, Serruys P, Knudtson M, van Es G, van der Zwaan C, Kleiman J, Gong J, Roecker E, Dreiling R, Alexander J, Anders R, for the EXCITE Trial Investigators. A Prospective Randomized Double-Blind Clinical Trial of Long-Term Oral Platelet Glycoprotein Receptor Blockade After Percutaneous Coronary Intervention. New England Journal of Medicine (342):1316-24, 2000.

 

 

THS 95.1(1997-1998) 850 trauma patients with persistent hypoperfusion despite pre-hospital therapy admitted to trauma center in the United States. Goal was 35-40 centers. Randomized clinical trial. Comparison of DCLHB, a purified human hemoglobin solution, versus saline. Primary outcome was 28 day mortality. Industry sponsored with special IND approved. First study conducted under DHHS Waiver of Informed Consent Requirements in Certain Emergency Research.

 

   

Sloan EP, Koenigsberg M, Gens D, Cipolle M, Runge J, Mallory MN, Rodman G, for the DCLHb Traumatic Hemorrhagic Shock Study Group. Diaspirin Cross-Linked Hemoglobin (DCLHb) in the Treatment of Severe Traumatic Hemorrhagic Shock: A Randomized Controlled Efficacy Trial. Journal of the American Medical Association 282:1857-1864, 1999.

 

   

Lewis RJ, Berry DA, Cryer H, Fost N, Krome R, Washington GR, Houghton J, Blue JW, Bechhofer R, Cook T, and Fisher M. Monitoring a Clinical Trial Conducted Under the Food and Drug Administration Regulations Allowing a Waiver of Prospective Informed Consent: The Diaspirin Cross-Linked Hemoglobin Traumatic Hemorrhagic Shock Efficacy Trial. Annals of Emergency Medicine 38:397-404, 2001.

 

 

AB-02 (1995-1998) Approximately 270 patients with depressed ventricular function undergoing coronary artery bypass graft surgery . Randomized, double-blind clinical trial. Comparison of Adenosin, an additive to cardioplegic solutions, versus placebo. Primary outcome was the amount of 1) dopamine and 2) inotropic support used during the first seven postoperative days. Industry sponsored.

 

 

VEST (1994-1998) 3833 patients with severe left ventricular heart failure (Class III and IV) from the United States and Canada in 189 centers. Randomized double-blind clinical trial. Comparison of Vesnarinone, an ionotropic drug, versus placebo. Primary outcome was mortality and cardiovascular morbidity. Industry sponsored and coordinated through an academic network. Results presented at November 1996 American Heart Association Meeting and at March 1997 American College of Cardiology Meeting.

 

   

Cohn J, Goldstein S, Greenberg B, Lorell B, Bourge R, Jaski B, Gottlieb S, McGrew F, DeMets D, and White B, for the VESNARINONE Trial Investigators. A dose-dependent increase in mortality with vesnarinone among patients with severe heart failure. New England Journal of Medicine 339:1810-1816, 1998.

 

 

ACTS (1992-1995) 730 patients with amyotrophic lateral sclerosis in North America at 36 centers. Randomized, double-blind clinical trial. Comparison of rHCNTF, a neurotrophic growth factor, in two doses versus placebo. Primary outcome was rate of change from baseline in isometric muscle strength to nine months. Industry sponsored. SDAC served as the data management center as well as the analysis center. Results presented at May 1995 American Academy of Neurology Meeting.

 

    ALS CNTF Treatment Study Group. A Double-Blind Placebo-Controlled Clinical Trial of Subcutaneous Recombinant Human Ciliary Neurotrophic Factor (rHCNTF) in Amyotrophic Lateral Sclerosis. Neurology 46:1244-1249, 1996.

 
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