drugset / Trial / NCT02069119

A Trial to Determine the Safety, Pharmacokinetics, and Efficacy of OPC-108459 Administered as a Single Intravenous Dose to Patients With Paroxysmal or Persistent Atrial Fibrillation (AF)

NCT02069119 ↗

Phase 1 Completed 48 enrolled Otsuka Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To investigate the safety, pharmacokinetics, and efficacy following 30-minute continuous intravenous administration of OPC-108459 at 0.4, 0.8, 1.6, or 2.4 mg/kg or placebo to patients with paroxysmal or persistent atrial fibrillation

Timeline

Start
2014-02
Primary completion
2015-08
Completion
2015-08

Drugs

EvaluationDrugModalityDoseRoute
Subject OPC-108459 Unknown 0.4 mg/kg Intravenous
Subject OPC-108459 Unknown 0.8 mg/kg Intravenous
Subject OPC-108459 Unknown 1.6 mg/kg Intravenous
Subject OPC-108459 Unknown 2.4 mg/kg Intravenous

Indications