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Cardiome And Astellas Announce Positive Results From ACT 2 Trial

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VANCOUVER and DEERFIELD, IL, June 04, 2007 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. and its co-development partner Astellas Pharma US, Inc. ("Astellas") today announced results from their recently completed Phase 3 clinical study, called ACT 2. The trial evaluated the efficacy and safety of the intravenous formulation of vernakalant hydrochloride ("vernakalant (iv)") for the treatment of patients who developed atrial fibrillation or atrial flutter between 24 hours and 7 days following coronary artery bypass graft (CABG) or valve replacement surgery. In the atrial fibrillation population, 47% of patients dosed with vernakalant (iv) experienced conversion to normal heart rhythm within 90 minutes, as compared to 14% of placebo patients, a statistically significant difference (p=0.0001).

The ACT 2 study data suggests that vernakalant (iv) was well-tolerated in the studied patient population. In the 30-day interval following drug administration, serious adverse events occurred in 9% of all patients dosed with vernakalant (iv) and 11% of all placebo patients. Potentially drug-related serious adverse events occurred in 2% of patients who received vernakalant (iv) and 0% of placebo patients. There were no cases of drug-related "Torsades de Pointes", a specific and well-characterized ventricular arrhythmia.

The study achieved its primary endpoint in the combined atrial fibrillation and atrial flutter groups, showing that 45% of patients receiving vernakalant (iv) converted to normal heart rhythm within 90 minutes, as compared to 15% of placebo patients within the same time period (p=0.0002). Of the 10 patients in the atrial flutter population, no patients in the drug group and one patient in the placebo group converted to normal heart rhythm. A total of 190 patients were randomized in the study, of which 161 received treatment.

In the patients treated with vernakalant (iv
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