ILLUMINATE (2004-present) Approximately 13,000 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.
Completed Trials, Ongoing Publications
COMPANION (1999-2002) Approximately 2200 patients with congestive heart failure. Randomized clinical trial. Comparison of optimal drug treatment versus optimal drug treatment with biventricular pacing versus optimal drug treatment with biventricular pacing and defibrillation. Primary endpoint was all-cause mortality/all-cause hospitalization. Results presented at March 2003 American College of Cardiology Late-Breaking Trials and September 2003 Heart Failure Society of America Late-Breaking Trials.
Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, Carson P, DiCarlo L, DeMets D, White BG, DeVries DW, and Feldman AM. Cardiac-Resynchronization Therapy with or without and Implantable Defibrillator in Advanced Chronic Heart Failure. The New England Journal of Medicine 350: 2140-50, 2004.
Carson P, Anand I, O'Connor C, Jaski B, Steinber J, Lwin A, Lindenfeld J. Ghali J, Barnet J, Feldman AM, Bristow MR. Mode of Death in Advanced Heart Failure: the Comparison of Medical, Pacing, and Defibrillation Therapies in Heart Failure, Journal of the American College of Cardiology 46, No. 12: 2329-34, 2005.
Completed Trials and Publications
PAA20001 (2004-2005) A multicenter, three staged, randomized, parallel group, double-blind, fenofibrate and placebo controlled dose-response evaluation of the safety, tolerability and effects on plasma high-density lipoprotein cholesterol and triglycerides of eight weeks treatment with daily doses in otherwise healthy subjects with low HDLc, mildly to moderately elevated triglycerides and normal low-density lipoprotein cholesterol. Study drug is a peroxisome proliferator-activated receptor (alpha) agonist. Industry sponsored.
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 is all cause mortality or cardiovascular hospitalization. Industry sponsored.
ENABLE (1999-2001) Approximately 1600 patients in two trials (800 from North America and 800 from Europe, Australia and Israel). Randomized, double-blind, placebo-controlled trial of an endothelin antagonist in patients with advanced chronic heart failure. Primary endpoints are (1) all-cause mortality/hospitalization for heart failure and (2) clinical status at nine months. Industry sponsored. Results presented at March 2002 American College of Cardiology, manuscript preparation ongoing.
PRAISE 2 (1996-2000) Approximately 1800 patients with severe heart failure of non-ischemic etiology randomized to amlodipine vs placebo with the outcomes of all-cause mortality, cardiovascular mortality, and health care resource utilization. Industry sponsored. Results presented at March 2000 American College of Cardiology Meeting. Manuscript in preparation.
REACH (1997-1998) Approximately 300 patient with heart failure randomized to either of two doses of an endothelin antagonist or placebo. Primary endpoint was change in clinical status. Industry sponsored. Results presented at 1998 American Heart Association Meeting. Manuscript in preparation.
Selected Publications
Palta M, Sadek M, Barnet JH, Evans M, Weinstein MR, McGuinness G, Peters ME, Gabbert D, Fryback D, Farrell P. Evaluation of criteria for chronic lung disease in surviving very low birth weight infants. The Journal of Pediatrics, 132 (1): 57-63, 1998.
