Trials / Completed
CompletedNCT02069119
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)
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 85 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OPC-108459 | |
| DRUG | Placebo |
Timeline
- Start date
- 2014-02-01
- Primary completion
- 2015-08-01
- Completion
- 2015-08-01
- First posted
- 2014-02-21
- Last updated
- 2018-11-05
- Results posted
- 2018-11-05
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT02069119. Inclusion in this directory is not an endorsement.