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

Primary Purpose

Atrial Fibrillation

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
saline
K201
Sponsored by
Sequel Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo

K201

Arm Description

intravenous K201

Outcomes

Primary Outcome Measures

proportion of subjects who convert to sinus rhythm

Secondary Outcome Measures

Full Information

First Posted
December 12, 2010
Last Updated
May 13, 2011
Sponsor
Sequel Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01259622
Brief Title
Effects of Intravenous K201 on the Restoration of Sinus Rhythm in Subjects With Symptomatic Atrial Fibrillation
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Terminated
Study Start Date
February 2011 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Sequel Pharmaceuticals, Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
K201
Arm Type
Experimental
Arm Description
intravenous K201
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
intravenous infusion
Intervention Type
Drug
Intervention Name(s)
K201
Intervention Description
intravenous infusion
Primary Outcome Measure Information:
Title
proportion of subjects who convert to sinus rhythm
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Chamberlin, MD
Organizational Affiliation
Sequel Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Esbjerg
Country
Denmark
City
Glostrup
Country
Denmark
City
Haderslev
Country
Denmark
City
Hellerup
Country
Denmark
City
Herlev
Country
Denmark
City
Hvidovre
Country
Denmark
City
Kolding
Country
Denmark
City
København
Country
Denmark
City
Odense
Country
Denmark
City
Roskilde
Country
Denmark
City
Silkeborg
Country
Denmark
City
Svendborg
Country
Denmark
City
Varde
Country
Denmark
City
Viborg
Country
Denmark
City
Ashkelon
Country
Israel
City
Rehovot
Country
Israel
City
Safed
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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