CVTX's ranolazine hits endpoint
CV Therapeutics (CVTX) said its double-blind, international Phase III CARISA trial of ranolazine in 823 chronic stable angina patients met the primary efficacy endpoint of an increase in symptom-limited exercise duration at trough compound concentrations (12 hours after dosing) compared to placebo. CVTX plans to submit an NDA for ranolazine to treat chronic stable angina in the second half of 2002.
In CARISA, the primary endpoint increased by an average of 116 seconds in ranolazine patients compared to an average increase of 92 seconds in the placebo group (p=0.012). The primary endpoint increased by an average of 115 seconds in the 750 mg ranolazine group and 116 seconds for the 1,000 mg group (p<=0.03 compared to placebo). Baseline average exercise time before therapy was about 7 minutes. CVTX said that ranolazine's exercise duration increase is similar to that of marketed anti-angina products. ...