Cardiome Pharma Corp. (NASDAQ: CRME/TSX: COM) and its co-development partner Astellas Pharma US, Inc. ("Astellas") announced today that patient enrolment has begun for the ACT 5 trial, a confirmatory Phase 3 clinical trial of KYNAPID(TM) (vernakalant hydrochloride) Injection, a drug product candidate under development for the rapid conversion of atrial fibrillation to sinus rhythm. The ACT 5 trial, previously announced in August 2009, is expected to be completed in the first half of 2011.
The ACT 5 Trial
The ACT 5 trial, "A Phase 3b Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Vernakalant Hydrochloride Injection in Patients with Recent Onset Symptomatic Atrial Fibrillation," will enroll approximately 450 patients across approximately 100 centres focused in North America. The study is designed to measure the safety and efficacy of KYNAPID Injection in patients with recent-onset atrial fibrillation (more than 3 hours but less than 7 days). The study excludes patients with evidence or history of congestive heart failure (CHF). Further, the study will evaluate the influence of CYP2D6 genotype status on the pharmacokinetics and pharmacodynamics of vernakalant (and its metabolites), and also allows for an exploratory analysis of safety and healthcare resource utilization between vernakalant and electrocardioversion (ECV).
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