CV Therapeutics (CVTX) Said Regadenoson Met Primary Endpoint
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CV Therapeutics, Inc. (Nasdaq: CVTX) and Astellas Pharma US, Inc. announced today that the second of two Phase 3 clinical studies of regadenoson met its primary endpoint. A prior identically designed Phase 3 study, completed in 2005, also met its primary endpoint.
In this study, regadenoson met its primary endpoint by showing with 95 percent confidence that MPI studies conducted with regadenoson were comparable to MPI studies conducted with Adenoscan (adenosine injection).
Based on the results of these two Phase 3 clinical trials, CV Therapeutics plans to submit a new drug application to the FDA in mid-2007.
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