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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00126074
• Other study ID #: S219.3.118
• Secondary ID: 2004-000346-21
• Status: Completed
• Phase: Phase 3
• First received: August 1, 2005
• Last updated: January 15, 2015
• Start date: October 2004
• Est. completion date: March 2006

Study information

• Verified date: March 2006
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug AgencyGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyItaly: The Italian Medicines AgencyPoland: Ministry of HealthSpain: Spanish Agency of MedicinesUnited 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 female patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Female
• 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

• 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

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
Bulgaria	Site 5	Pleven
Bulgaria	Site 2	Sofia
Bulgaria	Site 3	Sofia
Bulgaria	Site 4	Sofia
Bulgaria	Site 6	Sofia
Bulgaria	Site 7	Sofia
Germany	Site 8	Mannheim
Hungary	Site 11	Budapest
Hungary	Site 12	Budapest
Hungary	Site 14	Budapest
Hungary	Site 15	Budapest
Hungary	Site 9	Budapest
Hungary	Site 13	Kecskemet
Hungary	Site 10	Korhaz
Italy	Site 16	Piacenza
Poland	Site 22	Chrzanow
Poland	Site 20	Gdansk
Poland	Site 25	Gdynia
Poland	Site 19	Katowice
Poland	Site 18	Krakow
Poland	Site 24	Szczecin
Poland	Site 17	Tarnow
Poland	Site 23	Walbrzych
Poland	Site 21	Zakopane
United States	Site 26	Honolulu	Hawaii
United States	Site 27	Tullahoma	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals

Countries where clinical trial is conducted

United States,  Bulgaria,  Germany,  Hungary,  Italy,  Poland,