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

• Sponsor: Sequel Pharmaceuticals, Inc (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01259622
• Collaborator: (none)
• Enrollment: 80
• Locations: 17
• Arms: 2
• Duration (Months): 10
• Patients Per Site: 4.7
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Drug: saline; Drug: K201	Phase 2

Study Design

• Study Type: Interventional
• Anticipated 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: Feb 1, 2011
• Anticipated Primary Completion Date: Oct 1, 2011
• Anticipated Study Completion Date: Dec 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. proportion of subjects who convert to sinus rhythm [24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1		Esbjerg		Denmark
2		Glostrup		Denmark
3		Haderslev		Denmark
4		Hellerup		Denmark
5		Herlev		Denmark
6		Hvidovre		Denmark
7		Kolding		Denmark
8		København		Denmark
9		Odense		Denmark
10		Roskilde		Denmark
11		Silkeborg		Denmark
12		Svendborg		Denmark
13		Varde		Denmark
14		Viborg		Denmark
15		Ashkelon		Israel
16		Rehovot		Israel
17		Safed		Israel

Sponsors and Collaborators

• Sequel Pharmaceuticals, Inc

Investigators

• Study Director: Paul Chamberlin, MD, Sequel Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01259622
• Other Study ID Numbers: CJI-202
• First Posted: Dec 14, 2010
• Last Update Posted: May 16, 2011
• Last Verified: May 1, 2011

• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of May 16, 2011