FDAnews
www.fdanews.com/articles/73941-atherogenics-phase-iii-arise-trial-to-close-screening

ATHEROGENICS PHASE III ARISE TRIAL TO CLOSE SCREENING

July 1, 2005

AtheroGenics, a pharmaceutical company focused on the treatment of chronic inflammatory diseases, announced that it has notified all clinical sites involved in its worldwide pivotal Phase III clinical study, ARISE (Aggressive Reduction in Inflammation Stops Events), that screening for patients in the trial will close on Friday, July 8, 2005.

AtheroGenics has confirmed that by July 8, 2005, a sufficient number of patients will have entered screening to ensure randomization of more than 6,000 patients, the goal of the modified ARISE protocol agreed to with the FDA earlier this year. Patients who enter screening by July 8th should complete all prerandomization checks so that they can be randomized within the next few weeks.

ARISE is a double-blind, placebo-controlled multicenter pivotal Phase III trial, examining the impact of AGI-1067 on important clinical event measures such as death due to coronary disease, myocardial infarction (heart attack), stroke, coronary revascularization and unstable angina, in patients who have coronary heart disease.

The study is designed to assess the incremental benefits of AGI-1067 over current "standard of care" in this patient population. As such, patients in the trial, including those on placebo, will be receiving other appropriate heart disease medications including statins and other cholesterol-lowering therapies, high blood pressure medications, and anticlotting agents. ARISE has enrolled patients in more than 250 cardiac centers in the U.S., Canada, the United Kingdom and South Africa. The trial is expected to end when a minimum of 990 primary events have occurred.