This item is part of Stockwatch's value added news feed and is only available to Stockwatch subscribers.Here is a sample of this item:Cardiome begins patient enrolment for Kynapid test 2009-10-28 17:20 ET - News Release
Mr. Peter Hofman
reports CARDIOME AND ASTELLAS ANNOUNCE INITIATION OF PATIENT ENROLMENT IN ACT 5 TRIAL Cardiome Pharma Corp. and co-development partner Astellas Pharma US, Inc. have begun patient enrolment for the Act 5 trial, a confirmatory phase 3 clinical trial of Kynapid (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 three hours but less than seven 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 health care resource utilization between vernakalant and electrocardioversion (ECV).
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