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

Woman and Man

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Extract

The primary safety objective of this study is to evaluate the safety of vernakalant injection in subjects with recent onset (AF > 3 hours to less than or equal to 7 days), symptomatic atrial fibrillation, and no evidence or history of congestive heart failure (CHF). The primary efficacy objective is to demonstrate the efficacy of vernakalant injection in converting atrial fibrillation (AF) to sinus rhythm (SR) in subjects with recent onset (AF > 3h to less than or equal to 7 days), symptomatic atrial fibrillation and no evidence or history of congestive heart failure (CHF).

Inclusion criteria

Recent Onset Symptomatic Atrial Fibrillation

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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 Atria...