Study of K201 Injection on Restoration of Sinus Rhythm in Subjects Who Are in Atrial Fibrillation
Phase 2
Completed
- Conditions
- Atrial Fibrillation
- Interventions
- Drug: K201 Injection
- Registration Number
- NCT00626652
- Lead Sponsor
- Sequel Pharmaceuticals, Inc
- Brief Summary
To evaluate the effects of K201 on sinus rhythm restoration, symptom score, various cardiovascular parameters, and safety.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 153
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 K201 Injection -
- Primary Outcome Measures
Name Time Method Restoration of sinus rhythm 24hrs
- Secondary Outcome Measures
Name Time Method