Effects of Intravenous K201 on the Restoration of Sinus Rhythm in Subjects With Symptomatic Atrial Fibrillation (TUNDRA-AF)

A mulTi-center, Randomized, doUble-bliNded, Placebo-controlled Dose-escalating Study of the Effects of K201 on the RestorAtion of Sinus Rhythm in Subjects With Symptomatic Atrial Fibrillation of Recent Onset

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.

Study Overview

• Status: Terminated
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: saline; Drug: K201

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Esbjerg, Denmark
  • Glostrup, Denmark
  • Haderslev, Denmark
  • Hellerup, Denmark
  • Herlev, Denmark
  • Hvidovre, Denmark
  • Kolding, Denmark
  • København, Denmark
  • Odense, Denmark
  • Roskilde, Denmark
  • Silkeborg, Denmark
  • Svendborg, Denmark
  • Varde, Denmark
  • Viborg, Denmark
• Israel
  • Ashkelon, Israel
  • Rehovot, Israel
  • Safed, Israel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: saline; intravenous infusion
Experimental: K201; intravenous K201	Drug: K201; intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
proportion of subjects who convert to sinus rhythm	24 hours

Collaborators and Investigators

• Sponsor: Sequel Pharmaceuticals, Inc
• Investigators: Study Director: Paul Chamberlin, MD, Sequel Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Anticipated): October 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: December 12, 2010
• First Submitted That Met QC Criteria: December 13, 2010
• First Posted (Estimate): December 14, 2010

Study Record Updates

• Last Update Posted (Estimate): May 16, 2011
• Last Update Submitted That Met QC Criteria: May 13, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CJI-202