At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 48 enrolled
Drug / intervention
OPC-108459 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Parallel-group-comparison, Double-blind, Placebo-controlled, Randomized 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
In Brief
A Phase 1 clinical trial evaluating OPC-108459 and Placebo for Atrial Fibrillation. Completed, enrolled 48 participants across 1 site.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2014
First PostedFeb 2014
Primary CompletionAug 2015
TodayJul 2026
First PostedFeb 21, 2014
Enrollment StartFeb 1, 2014
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 12.4 years ago
Interventions
OPC-108459drug
Placebodrug