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

Phase 3

Completed

• Conditions: Atrial Fibrillation; Atrial Flutter

• Registration Number: NCT00126074
• Lead Sponsor: Solvay Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-08-01
• Study First Submitted QC: 2005-08-01
• Study First Posted: 2005-08-02
• Status Verified: 2006-03
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Last Update Submitted: 2015-01-15
• Last Update Posted: 2015-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (26)

Site 26; 🇺🇸 Honolulu, Hawaii, United States

Site 27; 🇺🇸 Tullahoma, Tennessee, United States

Site 8; 🇩🇪 Mannheim, Germany

Site 12; 🇭🇺 Budapest, Hungary

Site 15; 🇭🇺 Budapest, Hungary

Site 13; 🇭🇺 Kecskemet, Hungary

Site 10; 🇭🇺 Korhaz, Hungary

Site 16; 🇮🇹 Piacenza, Italy

Site 23; 🇵🇱 Walbrzych, Poland

Site 17; 🇵🇱 Tarnow, Poland

Site 21; 🇵🇱 Zakopane, Poland

Site 5; 🇧🇬 Pleven, Bulgaria

Site 2; 🇧🇬 Sofia, Bulgaria

Site 3; 🇧🇬 Sofia, Bulgaria

Site 4; 🇧🇬 Sofia, Bulgaria

Site 6; 🇧🇬 Sofia, Bulgaria

Site 7; 🇧🇬 Sofia, Bulgaria

Site 11; 🇭🇺 Budapest, Hungary

Site 14; 🇭🇺 Budapest, Hungary

Site 24; 🇵🇱 Szczecin, Poland

Site 9; 🇭🇺 Budapest, Hungary

Site 22; 🇵🇱 Chrzanow, Poland

Site 20; 🇵🇱 Gdansk, Poland

Site 25; 🇵🇱 Gdynia, Poland

Site 19; 🇵🇱 Katowice, Poland

Site 18; 🇵🇱 Krakow, Poland