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news.Vasogen Inc has reached full enrollment in the 2,000 patient pivotal phase III Acclaim trial in advanced chronic heart failure. The study is designed to evaluate the use of the Celacade technology to reduce hospitalization and death in heart patients.
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The trial is a double-blind, placebo- controlled, multinational clinical study using patients with advanced chronic heart failure.
Vasogen has enrolled over 2,000 patients at 173 clinical sites in North America, Europe and Israel. An independent steering committee comprised of thought leaders in heart failure from around the world designed the study to investigate the impact of Vasogen’s Celacade technology on reducing the risk of death and cardiovascular hospitalization in patients with advanced chronic heart failure.
Acclaim is an event-rate-driven study that will reach its primary endpoint when 701 patients have experienced a primary endpoint event, defined as either death or first cardiovascular hospitalization. Based on the current number of events and current event-rate trends, the trial remains on schedule and is expected to reach its primary endpoint during the second half of 2005.
According to Vasogen, Celacade technology works by delivering oxidative stress to a sample of a patient’s own cells during a brief outpatient procedure, which is administered monthly. During the procedure, a small sample of blood is collected into using a disposable cartridge, exposed to controlled oxidative stress using Celacade technology, and then re-administered to the patient intramuscularly. As yet, trials have revealed no significant side effects of the treatment.
Heart failure, which affects over ten million people in North America and Europe, is associated with more than 600,000 deaths each year and is the leading cause of hospitalizations in people over the age of 65.