Ascending Dose Study of OPC-108459 Intravenous Infusions in Patients With Paroxysmal and Persistent Atrial Fibrillation

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT01483183

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

40

Starts

2011-11-01

Expected to finish

2015-10-01

Last updated by the study team

2017-04-10

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Otsuka Investigational Site — Washington D.C., District of Columbia, United States
• Otsuka Investigational Site — Hollywood, Florida, United States
• Otsuka Investigational Site — Jacksonville, Florida, United States
• Otsuka Investigational Site — Sarasota, Florida, United States
• Otsuka Investigational Site — Lexington, Kentucky, United States
• Otsuka Investigational Site — New Orleans, Louisiana, United States
• Otsuka Investigational Site — Johnson City, New York, United States
• Otsuka Investigational Site — Germantown, Tennessee, United States
• Otsuka Investigational Site — Houston, Texas, United States
• Otsuka Investigational Site — Berlin, Germany
• Otsuka Investigational Site — Hamburg, Germany
• Otsuka Investigational Site — Leipzig, Germany
• Otsuka Investigational Site — Pirna, Germany
• Otsuka Investigational Site — San Fermo, Como, Italy
• Otsuka Investigational Site — Ancona, Italy
• Otsuka Investigational Site — Bologna, Italy
• Otsuka Investigational Site — Cremona, Italy
• Otsuka Investigational Site — Amsterdam, Netherlands
• Otsuka Investigational Site — Groningen, Netherlands
• Otsuka Investigational Site — Fuenlabrada, Madrid, Spain
• Otsuka Investigational Site — Barcelona, Spain
• Otsuka Investigational Site — Granada, Spain
• Otsuka Investigational Site — Madrid, Spain
• Otsuka Investigational Site — Madrid, Spain
• Otsuka Investigational Site — Chertsey, Surrey, United Kingdom

Full record on ClinicalTrials.gov

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