CARDIOME COMPLETES ACT 3 ENROLLMENT PHASE

Cardiome Pharma has completed patient enrollment in its second pivotal Phase III atrial fibrillation trial, ACT 3. The study, which is being conducted by co-development partner Astellas Pharma, will evaluate the safety and efficacy of intravenous RSD1235 in 276 patients with atrial arrhythmia.

The aim of the study is acute conversion of atrial fibrillation to normal heart rhythm in recent-onset atrial fibrillation patients. It will also evaluate patients with longer-term atrial fibrillation and patients with atrial flutter. Safety observations focus on sensory and cardiovascular effects of the drug, with particular emphasis on lack of side-effect arrhythmias.

Atrial fibrillation is an abnormal heart rhythm that affects the atria of the heart, lowering the heart's pumping capacity. Immediate symptoms are breathlessness and fatigue. Long-term effects include increased risk of both stroke and congestive heart failure. In 2002, there were over 7 million cases of atrial arrhythmia in the developed world.