Cardiome Pharma has received approval from the US Food and DrugAdministration and the Canadian Therapeutic Product Directorate to begin a Phase II clinical trial of intravenously-administered RSD1235 for the treatment of atrial fibrillation.
Preclinical studies have shown that RSD1235 is effective in converting atrial arrhythmia to normal heart rhythm, and terminated atrial fibrillation in a dose-dependent manner. A Phase I clinical trial has also demonstrated that the drug caused no significant adverse events and was well-tolerated in normal patients.
The planned trial, which will begin next month and results of which are expected in the third quarter 2002, will involve patients with recent onset of atrial fibrillation, with the primary endpoint being conversion of atrial fibrillation within 30 minutes of infusion.
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