Status:
TERMINATED
Ascending Dose Study of OPC-108459 Intravenous Infusions in Patients With Paroxysmal and Persistent Atrial Fibrillation
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Subjects with paroxysmal atrial fibrillation (AF) (recent or new onset) or subjects with persistent AF at the time of randomization
- Subjects who are hemodynamically stable
- Subjects with a low risk of thromboembolic potential
- Subjects who are willing to comply with the reproductive precautions
Exclusion
- Subjects with:
- History of long QT syndrome, Torsade de Pointes or an uncorrected QT interval of \> 450 ms
- History of myocardial infarction within 6 months of screening
- Acute coronary syndrome, angina or active myocardial ischemia diagnosed by ECG, or other imaging within 6 months of screening
- History of ventricular tachycardia, fibrillation, or resuscitated cardiac arrest
- History of clinically significant congenital heart disease
- Presence of severe aortic or mitral stenosis, aortic or mitral regurgitation, atrial septal defect, or other conditions leading to AF
- Diagnosis of heart failure NYHA Class II-IV or with an ejection fraction \<40% (Part 1 only)
- Diagnosis of heart failure NYHA Class IV or NYHA I, II, or III with an ejection fraction \<35% (Part 2 only)
- Concomitant treatment with class I or III anti-arrhythmics agents unless the medication was discontinued more than 5 half-lives before dosing
- History of seizures
- Diagnosis of atrial flutter
- Diagnosis of stroke, TIA (transient ischemic attack), or any transient neurological deficit within 1 year of screening or known carotid artery stenosis of \>50%
- Cardiac surgery within 3 months of screening
- Bradycardia (\< 50 bpm) or sick sinus syndrome, unless controlled by a pacemaker
- Current reversible cause of AF
- Wolff-Parkinson-White syndrome
- Any congenital abnormality, severe valve disease
- Subjects who have taken another investigational product within 30 days of dosing
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01483183
Start Date
November 1 2011
End Date
October 1 2015
Last Update
April 10 2017
Active Locations (25)
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1
Otsuka Investigational Site
Washington D.C., District of Columbia, United States, 20422
2
Otsuka Investigational Site
Hollywood, Florida, United States, 33021
3
Otsuka Investigational Site
Jacksonville, Florida, United States, 32209
4
Otsuka Investigational Site
Sarasota, Florida, United States, 34232