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

Phase 2

Terminated

• Conditions: Atrial Fibrillation
• Interventions: Drug: saline; Drug: K201

• Registration Number: NCT01259622
• Lead Sponsor: Sequel Pharmaceuticals, Inc

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-12
• Study First Submitted QC: 2010-12-13
• Study First Posted: 2010-12-14
• Study Start: 2011-02
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-13
• Last Update Posted: 2011-05-16
• Primary Completion: 2011-10
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	saline	-
K201	K201	intravenous K201

Primary Outcome Measures

Name	Time	Method
proportion of subjects who convert to sinus rhythm	24 hours