COX 2 INHIBITOR PROGRAM (2005-present) Approximately 40,000 subjects in multiple indications including osteoarthritis, rheumatoid arthritis, chronic low back pain, neuropathic pain, visceral pain an acute pain. This clinical development program for a dual-acting COX2 inhibitor is expected to include approximately 36 phase III multicenter, double-blind, double-dummy, randomized, placebo-and active comparator-controlled, parallel group studies. Industry Sponsored.
ARIES (2004-2006) Approximately 372 patients with pulmonary arterial hypertension in two randomized double-blind clinical trials in 40 international sites. Comparison of ambrisentan, an endothelin A receptor antagonist, versus placebo. Primary endpoint is the change from baseline in the six-minute walk distance evaluated after 12 weeks of therapy. Industry sponsored.
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 is progression of retinopathy. Industry sponsored.
DFMO in Skin Cancer (1998-2004) 291 patients with a prior history of skin cancer at University of Wisconsin Comprehensive Cancer Center (UWCCC). Randomized double-blind clinical trial. Comparison of DFMO, a chemopreventive agent, versus placebo. Primary outcome is rate of new skin cancer development. NCI sponsored.
Bladder Cancer (1999-2004) Approximately 450 patients with low grade superficial bladder cancer, in a randomized double-blind study of a chemopreventive agent in addition to standard care following surgical resection of tumor. Primary endpoint is disease recurrence. Jointly sponsored by NCI and industry.
COPERNICUS (1997-2000) Approximately 2300 patients with severe congestive heart failure (Class IV) from North America, Europe, Australia, and Asia. Randomized, double-blind, placebo-controlled study of carvedilol. Primary endpoint was all-cause mortality. Industry sponsored. Results presented at August 2000 European College of Cardiology Meeting, November 2000 American Heart Association Meeting, and March 2001 American College of Cardiology Meeting.
Selected Publications
Packer M, Coats A, Fowler M, Katus H, Krum H, Mohacsi P, Rouleau J, Tendera M, Castaigne A, Roecker E, Schultz M, and DeMets D, for the Carvedilol Prospective Randomized Cumulative Randomized Cumulative Survival Study Group. Effect of Carvedilol on Survival in Severe Chronic Heart Failure. NEJM 344:1651-1658, 2001.
