Published in Medical Letter on the CDC and FDA, October 8th, 2006
The Phase III trial, known as NAPA-2 (Novel Arterial Perfusion with Alfimeprase-2), is the first of two multinational trials in the Phase III alfimeprase program for acute PAO. This randomized, double-blind study compared the efficacy and safety of 0.3 mg/kg of alfimeprase versus placebo in approximately 300 patients in over 100 centers worldwide.
The study's primary endpoint is avoidance of open vascular surgery within 30 days of treatment. Open vascular surgery...
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