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



Status:Terminated
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 85
Updated:4/21/2016
Start Date:November 2011
End Date:October 2015

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A Multi-center, Parallel-group, Double-blind, Placebo-controlled, Randomized, Ascending Dose Trial to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Infusions of OPC-108459 Administered to Subjects With Paroxysmal and Persistent Atrial Fibrillation

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.

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 of two parts. Each part will evaluate two populations of subjects
presenting for cardioversion in a hospital setting.

Cohorts of paroxysmal and persistent subjects may have their dose increased independently.

Inclusion Criteria:

- 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 Criteria:

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
We found this trial at
10
sites
Washington, District of Columbia 20010
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Washington,
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Berlin,
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Germantown, Tennessee 38138
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Germantown, TN
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Hollywood, Florida 33021
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Hollywood, FL
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Houston, Texas 77030
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Houston, TX
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Jacksonville, Florida 32216
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Jacksonville, FL
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Johnson City, New York 13790
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Johnson City, NY
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Lexington, Kentucky 40504
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Lexington, KY
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New Orleans, Louisiana 70112
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New Orleans, LA
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Sarasota, Florida 34232
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Sarasota, FL
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