Status:
COMPLETED
Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Female Subjects
Lead Sponsor:
Solvay Pharmaceuticals
Conditions:
Atrial Fibrillation
Atrial Flutter
Eligibility:
FEMALE
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 female patients.
Eligibility Criteria
Inclusion
- Willing to sign informed consent before screening examinations are performed and before the study drug is administered
- Females \> 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
- Pregnancy and lactation
- Acute myocardial infarction and cerebrovascular accidents
- Coronary syndromes and congestive heart failure (CHF) New York Heart Association (NYHA) IV
- Life-threatening ventricular arrhythmias and electrocardiogram (ECG) abnormalities
- Concurrent antiarrhythmic treatments
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00126074
Start Date
October 1 2004
End Date
March 1 2006
Last Update
January 16 2015
Active Locations (26)
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1
Site 26
Honolulu, Hawaii, United States
2
Site 27
Tullahoma, Tennessee, United States
3
Site 5
Pleven, Bulgaria
4
Site 2
Sofia, Bulgaria