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

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

This study has been completed.

Sponsored by:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00126074

Purpose

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.

Condition	Intervention	Phase
Atrial Fibrillation Atrial Flutter	Drug: Tedisamil sesquifumarate	Phase III

Genetics Home Reference related topics:

Brugada syndrome familial atrial fibrillation short QT syndrome

ChemIDplus related topics:

Tedisamil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Solvay Pharmaceuticals:

Study Start Date:

October 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126074

Locations


United States, Hawaii
	Site 26
	Honolulu, Hawaii, United States

United States, Tennessee
	Site 27
	Tullahoma, Tennessee, United States

Bulgaria
	Site 2
	Sofia, Bulgaria
	Site 5
	Pleven, Bulgaria
	Site 4
	Sofia, Bulgaria
	Site 3
	Sofia, Bulgaria
	Site 6
	Sofia, Bulgaria
	Site 7
	Sofia, Bulgaria

Germany
	Site 8
	Mannheim, Germany

Hungary
	Site 9
	Budapest, Hungary
	Site 12
	Budapest, Hungary
	Site 11
	Budapest, Hungary
	Site 10
	Korhaz, Hungary
	Site 13
	Kecskemet, Hungary
	Site 14
	Budapest, Hungary
	Site 15
	Budapest, Hungary

Italy
	Site 16
	Piacenza, Italy

Poland
	Site 17
	Tarnow, Poland
	Site 18
	Krakow, Poland
	Site 19
	Katowice, Poland
	Site 25
	Gdynia, Poland
	Site 21
	Zakopane, Poland
	Site 22
	Chrzanow, Poland
	Site 23
	Walbrzych, Poland
	Site 24
	Szczecin, Poland
	Site 20
	Gdansk, Poland

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators


Study Director:	Global Clinical Director Solvay	Solvay Pharmaceuticals

More Information

Study ID Numbers:	S219.3.118, 2004-000346-21
First Received:	August 1, 2005
Last Updated:	March 24, 2006
ClinicalTrials.gov Identifier:	NCT00126074
Health Authority:	Bulgaria: Bulgarian Drug Agency; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Italy: The Italian Medicines Agency; Poland: Ministry of Health; Spain: Spanish Agency of Medicines; United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:

Atrial fibrillation, atrial flutter, anti-arrhythmic agents, conversion to normal sinus rhythm

Study placed in the following topic categories:

Heart Diseases

Atrial Fibrillation

Atrial Flutter

Tedisamil

Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes

Cardiotonic Agents

Therapeutic Uses

Physiological Effects of Drugs

Cardiovascular Diseases

Cardiovascular Agents

Anti-Arrhythmia Agents

Protective Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008