Status:
COMPLETED
Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Male Subjects
Lead Sponsor:
Solvay Pharmaceuticals
Conditions:
Atrial Fibrillation
Atrial Flutter
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to demonstrate the ability of tedisamil to convert atrial fibrillation or flutter into normal sinus rhythm (NSR) in male patients.
Eligibility Criteria
Inclusion
- Willing to sign informed consent before screening examinations are performed and before the study drug is administered
- Males \> 18 years of age
- Subjects with documented (60 second rhythm strip) symptomatic atrial fibrillation or flutter (duration \> 3 hours and \< 45 days) at the time of randomization
- Subjects who are in no distress and hemodynamically stable (supine systolic blood pressure \> 90 mmHg and diastolic blood pressure \< 105 mmHg)
Exclusion
- Acute myocardial infarction and cerebrovascular accidents
- Coronary and heart failure symptoms
- Life-threatening ventricular arrhythmias and electrocardiogram (ECG) abnormalities
- Electrolyte abnormalities
- Concurrent antiarrhythmic treatments
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00126061
Start Date
October 1 2004
End Date
January 1 2006
Last Update
January 16 2015
Active Locations (26)
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1
Site 26
Los Angeles, California, United States
2
Site 27
Santa Ana, California, United States
3
Site 24
Honolulu, Hawaii, United States
4
Site 25
Tullahoma, Tennessee, United States