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

Atrial Fibrillation Clinical Trial

— TUNDRA-AF  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01259622
• Other study ID #: CJI-202
• Status: Terminated
• Phase: Phase 2
• First received: December 12, 2010
• Last updated: May 13, 2011
• Start date: February 2011
• Est. completion date: December 2011

Study information

• Verified date: May 2011
• Source: Sequel Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationDenmark: Danish Medicines AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• saline
intravenous infusion
• K201
intravenous infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sequel Pharmaceuticals, Inc

Countries where clinical trial is conducted

Denmark,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of subjects who convert to sinus rhythm		24 hours	No