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

NCT01259622 | Terminated Phase 2 DMC

• 1 other identifier: CJI-202
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 17

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• proportion of subjects who convert to sinus rhythm

  24 hours

Study Arms (2)

placebo

PLACEBO COMPARATOR

Drug: saline

K201

EXPERIMENTAL

intravenous K201

Drug: K201

Interventions

saline DRUG

intravenous infusion

placebo

K201 DRUG

intravenous infusion

K201

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sequel Pharmaceuticals, Inc: lead

Study Sites (17)

Unknown Facility

Copenhagen, Denmark

Location

Unknown Facility

Esbjerg, Denmark

Location

Unknown Facility

Glostrup Municipality, Denmark

Location

Unknown Facility

Haderslev, Denmark

Location

Unknown Facility

Hellerup, Denmark

Location

Unknown Facility

Herlev, Denmark

Location

Unknown Facility

Hvidovre, Denmark

Location

Unknown Facility

Kolding, Denmark

Location

Unknown Facility

Odense, Denmark

Location

Unknown Facility

Roskilde, Denmark

Location

Unknown Facility

Silkeborg, Denmark

Location

Unknown Facility

Svendborg, Denmark

Location

Unknown Facility

Varde, Denmark

Location

Unknown Facility

Viborg, Denmark

Location

Unknown Facility

Ashkelon, Israel

Location

Unknown Facility

Rehovot, Israel

Location

Unknown Facility

Safed, Israel

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Sodium Chloride; K201 compound

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Paul Chamberlin, MD

  Sequel Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 12, 2010
• First Posted: December 14, 2010
• Study Start: February 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 16, 2011

Record last verified: 2011-05

Locations

DK (14); IL (3)