"On the 3Q conference call, Cardiome provided details on the design of the phase IIb trial, which is expected to begin 4Q06/1Q07. The trial will test 3 doses of oral vernakalant, 150mg, 300mg, and 500mg, 2x/day vs placebo. 600 patients will be randomized 1:1:1:1, for 150 patients per arm. The entry criteria and trial design will be similar to the phase IIa trial, except that the duration of the trial will be 90 days. Upon entry, patients will be hospitalized for a 3-day run-in with drug or placebo, electrically cardioverted, and then dosed with vernakalant or placebo for the next 87 days. The primary endpoint of the study will most likely be time to recurrence of a-fib. Cardiome will enroll patients at 150 European sites. Powering of the study assumes that about 40% of patients on placebo will maintain normal sinus rhythm, which is the rate observed in the shorter phase IIa study. An interim safety and efficacy analysis will take place around mid-2007"
<I like the dosage and the trial design...way to go> |
