Effects of Intravenous K201 on the Restoration of Sinus Rhythm in Subjects With Symptomatic Atrial Fibrillation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-12-31

Brief Summary

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The purpose of this study is to evaluate the effects of a single intravenous infusion of K201 compared to placebo in a dose escalating manner on conversion to sinus rhythm, reduction of subject's symptom score, and safety.

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

intravenous infusion

K201

intravenous K201

Group Type EXPERIMENTAL

K201

Intervention Type DRUG

intravenous infusion

Interventions

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saline

intravenous infusion

Intervention Type DRUG

K201

intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Symptomatic atrial fibrillation for more than 3 hours and less than 7 days (as dated by symptoms).
* Atrial fibrillation documented by ECG at the start of study drug infusion.

Exclusion Criteria

* Previous exposure to K201
* QTcF (Fridericia correction) \>440 ms
* QRS interval \> 140 ms
* Paced atrial or paced ventricular rhythm on ECG
* History of receiving another intravenous Class I or Class III antiarrhythmic drug within 3 days of randomization
* History of amiodarone (oral or IV) in the last 3 months.
* Clinical evidence or history of acute coronary syndrome (e.g. myocardial infarction, unstable angina) within 30 days prior to randomization
* History of failed electrical cardioversion at any time in the past
* History of polymorphic ventricular tachycardia (e.g. torsades des pointes)
* History or family history of Long QT Syndrome
* History of ventricular tachycardia requiring drug or device therapy
* Ejection fraction of 40% or less.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No