Study of K201 Injection on Restoration of Sinus Rhythm in Subjects Who Are in Atrial Fibrillation

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the effects of K201 on sinus rhythm restoration, symptom score, various cardiovascular parameters, and safety.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sequel Pharmaceuticals, Inc

Criteria

Inclusion Criteria:

• Symptomatic atrial fibrillation

• Atrial fibrillation documented by ECG

• Adherence to local clinical standards or the ACC/AHA/ESC practice guidelines for atrial fibrillation regarding thrombo-embolic event prevention and treatment.

Exclusion Criteria:

• Systolic blood pressure <100 mmHg

• Heart rate <50 bpm

• Temperature >38°C

• QT or QTcB >440 ms

• QRS >140 ms

• Paced atrial or ventricular rhythm on ECG

• Serum potassium <3.5 meq/L

• History of receiving another intravenous Class I or Class III antiarrhythmic drug within 3 days of randomization

• History of amiodarone in last 6 months.

• Clinical evidence of acute coronary syndrome

• Acute pulmonary edema or embolism

• Hyperthyroidism

• Acute pericarditis

• History of failed electrical cardioversion at any time

• History of torsades des pointes

• History of familial long QT interval syndrome

• History of ventricular tachycardia requiring drug or device therapy

• History of NYHA Heart Failure Class 3 or 4.