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

Phase 3

Completed

• Conditions: Atrial Flutter; Atrial Fibrillation

• Registration Number: NCT00126061
• 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 male 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
• Primary Completion: 2006-01
• Study Completion: 2006-01
• Status Verified: 2006-03
• Last Update Submitted: 2015-01-15
• Last Update Posted: 2015-01-16

Recruitment & Eligibility

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

Inclusion Criteria

• Willing to sign informed consent before screening examinations are performed and before the study drug is administered
• Males > 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

• Acute myocardial infarction and cerebrovascular accidents
• Coronary and heart failure symptoms
• Life-threatening ventricular arrhythmias and electrocardiogram (ECG) abnormalities
• Electrolyte abnormalities
• Concurrent antiarrhythmic treatments

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (26)

Site 12; 🇵🇱 Medyczna, Poland

Site 17; 🇷🇺 Moscow, Russian Federation

Site 11; 🇵🇱 Lodz, Poland

Site 9; 🇵🇱 Warszawa, Poland

Site 14; 🇷🇺 Moscow, Russian Federation

Site 13; 🇷🇺 Moscow, Russian Federation

Site 5; 🇨🇿 Brno, Czech Republic

Site 25; 🇺🇸 Tullahoma, Tennessee, United States

Site 15; 🇷🇺 Moscow, Russian Federation

Site 18; 🇺🇦 Kiev, Ukraine

Site 21; 🇺🇦 Kiev, Ukraine

Site 23; 🇺🇦 Odessa, Ukraine

Site 27; 🇺🇸 Santa Ana, California, United States

Site 26; 🇺🇸 Los Angeles, California, United States

Site 24; 🇺🇸 Honolulu, Hawaii, United States

Site 22; 🇺🇦 Zaporozhye, Ukraine

Site 8; 🇵🇱 Bydgoszcz, Poland

Site 4; 🇨🇿 Plzen, Czech Republic

Site 3; 🇨🇿 Prague, Czech Republic

Site 2; 🇨🇿 Prague, Czech Republic

Site 6; 🇨🇿 Prague, Czech Republic

Site 10; 🇵🇱 Lublin, Poland

Site 7; 🇵🇱 Warszawa, Poland

Site 20; 🇺🇦 Dnepropetrovsk, Ukraine

Site 19; 🇺🇦 Lviv, Ukraine

Site 16; 🇷🇺 Moscow, Russian Federation