Status:
COMPLETED
Study of K201 Injection on Restoration of Sinus Rhythm in Subjects Who Are in Atrial Fibrillation
Lead Sponsor:
Sequel Pharmaceuticals, Inc
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To evaluate the effects of K201 on sinus rhythm restoration, symptom score, various cardiovascular parameters, and safety.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00626652
Start Date
March 1 2008
End Date
December 1 2009
Last Update
January 8 2010
Active Locations (9)
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1
Ashkelon, Israel
2
Beersheba, Israel
3
Haifa, Israel
4
Holon, Israel