Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Female Subjects

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Solvay Pharmaceuticals
• Treatments: Tedisamil

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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