>>PALO ALTO, Calif., Aug 8, 2001 /PRNewswire via COMTEX/ -- CV Therapeutics, Inc. (Nasdaq: CVTX chart, msgs) today announced that the last patient has completed treatment in CARISA, the second pivotal Phase III trial for ranolazine in chronic angina. Over 700 chronic angina patients completed the 12-week trial. CARISA, (Combination Assessment of Ranolazine In Stable Angina), is a randomized double blind, placebo-controlled, parallel group, multi-national trial designed to compare the safety and efficacy of two dose regimens of ranolazine (750 mg twice daily and 1000 mg twice daily) to placebo during continued treatment with one of three other background anti-anginal medications.
"We are pleased to announce that the last CARISA patient has completed treatment according to plan," said Louis G. Lange, M.D., Ph.D., Chairman and Chief Executive Officer of CV Therapeutics, Inc. "With the completion of this important milestone for CVT, we will focus our efforts on analyzing the data and reporting the initial results during the fourth quarter of 2001."
The Company's first Phase III trial, MARISA (Monotherapy Assessment of Ranolazine In Stable Angina), was a randomized, double blind, placebo-controlled trial of ranolazine in patients not receiving any other anti-anginal drugs. The primary endpoint for MARISA was symptom-limited exercise duration at the time of trough plasma levels, which is also the primary endpoint for CARISA. Results from MARISA indicated that ranolazine was associated with statistically significant increases in chronic angina patients' treadmill exercise duration with no clinically meaningful effects on blood pressure or heart rate compared to placebo. Dose related adverse events included dizziness, nausea, asthenia and constipation.
Ranolazine has not been approved for marketing by the Food and Drug Administration or other foreign agencies. Ranolazine is presently being investigated in clinical trials subject to a United States IND and applicable foreign authority submissions. CV Therapeutics has not yet submitted an NDA to the FDA or equivalent application to any other foreign regulatory authorities for ranolazine, and ranolazine has not yet been determined to be safe or effective in humans for its intended use.<<
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