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

Atrial Fibrillation Clinical Trial

Official title:

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety of Intravenous Tedisamil Sesquifumarate in the Rapid Conversion to Normal Sinus Rhythm in Male Subjects With Recent Onset Atrial Fibrillation or Flutter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00126061
• Other study ID #: S219.3.117
• Secondary ID: 2004-000458-22
• Status: Completed
• Phase: Phase 3
• First received: August 1, 2005
• Last updated: January 15, 2015
• Start date: October 2004
• Est. completion date: January 2006

Study information

• Verified date: March 2006
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug ControlPoland: Ministry of HealthRussia: Pharmacological Committee, Ministry of HealthUkraine: State Pharmacological Center - Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter

Intervention

Drug:
• Tedisamil sesquifumarate

Locations

Country	Name	City	State
Czech Republic	Site 5	Brno
Czech Republic	Site 4	Plzen
Czech Republic	Site 2	Prague
Czech Republic	Site 3	Prague
Czech Republic	Site 6	Prague
Poland	Site 8	Bydgoszcz
Poland	Site 11	Lodz
Poland	Site 10	Lublin
Poland	Site 12	Medyczna
Poland	Site 7	Warszawa
Poland	Site 9	Warszawa
Russian Federation	Site 13	Moscow
Russian Federation	Site 14	Moscow
Russian Federation	Site 15	Moscow
Russian Federation	Site 16	Moscow
Russian Federation	Site 17	Moscow
Ukraine	Site 20	Dnepropetrovsk
Ukraine	Site 18	Kiev
Ukraine	Site 21	Kiev
Ukraine	Site 19	Lviv
Ukraine	Site 23	Odessa
Ukraine	Site 22	Zaporozhye
United States	Site 24	Honolulu	Hawaii
United States	Site 26	Los Angeles	California
United States	Site 27	Santa Ana	California
United States	Site 25	Tullahoma	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals

Countries where clinical trial is conducted

United States,  Czech Republic,  Poland,  Russian Federation,  Ukraine,