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

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ClinicalTrials.gov Identifier: NCT01259622
Recruitment Status : Terminated
First Posted : December 14, 2010
Last Update Posted : May 16, 2011
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: saline Drug: K201 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2011
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: placebo Drug: saline
intravenous infusion

Experimental: K201
intravenous K201
Drug: K201
intravenous infusion




Primary Outcome Measures :
  1. proportion of subjects who convert to sinus rhythm [ Time Frame: 24 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Howard C Dittrich, MD, Sequel Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01259622     History of Changes
Other Study ID Numbers: CJI-202
First Posted: December 14, 2010    Key Record Dates
Last Update Posted: May 16, 2011
Last Verified: May 2011

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