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

Solvay

Status and phase: Completed; Phase 3

Conditions: Atrial Flutter; Atrial Fibrillation

Treatments: Drug: Tedisamil sesquifumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00126074

2004-000346-21

S219.3.118

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind