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

This study has been terminated.
Sponsor:
Information provided by:
Sequel Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01259622
First received: December 12, 2010
Last updated: May 13, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
 Drug: saline
Drug: K201
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sequel Pharmaceuticals, Inc:

Primary Outcome Measures:
  • proportion of subjects who convert to sinus rhythm [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: February 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Drug: saline
intravenous infusion
Experimental: K201
intravenous K201
 Drug: K201
intravenous infusion

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259622

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
Sponsors and Collaborators
Sequel Pharmaceuticals, Inc
Investigators
Study Director: Paul Chamberlin, MD Sequel Pharmaceuticals
  More Information

No publications provided

Responsible Party: Howard C Dittrich, MD, Sequel Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01259622     History of Changes
Other Study ID Numbers: CJI-202
Study First Received: December 12, 2010
Last Updated: May 13, 2011
Health Authority: United States: Food and Drug Administration
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013