Overview

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