Atrial Fibrillation Clinical Trial
Official title:
A Multi-center, Parallel-group, Double-blind, Placebo-controlled, Randomized, Ascending Dose Trial to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Infusions of OPC-108459 Administered to Subjects With Paroxysmal and Persistent Atrial Fibrillation
The purpose of Part 1 of this study is to determine the maximally tolerated dose of
OPC-108459 in patients with paroxysmal and persistent atrial fibrillation (AF).
The purpose of Part 2 of this study is to determine potential efficacy of dose(s) of
OPC-108459 for the treatment of paroxysmal and persistent atrial fibrillation.
This trial will test the pharmacokinetic and pharmacodynamic characteristics of ascending
doses of OPC-108459 in separate populations of paroxysmal and persistent AF subjects.
The trial will consist of two parts. Each part will evaluate two populations of subjects
presenting for cardioversion in a hospital setting.
Cohorts of paroxysmal and persistent subjects may have their dose increased independently.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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