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SmithKline Beecham/Roche Coreg

Executive Summary

Carvedilol prospective randomized cumulative survival trial in patients with advanced chronic heart failure is stopped early due to positive survival benefit seen with the drug. The COPERNICUS trial, which had enrolled over 2,200 patients, began in October 1997 and had been scheduled to run until the end of 2001. The companies plan to file a supplemental NDA for the advanced chronic heart failure indication. Coreg was approved in May 1997 for the treatment of mild or moderate heart failure
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PS035802

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