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

This study has been completed.

First Received on August 1, 2005. Last Updated on March 24, 2006 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

Drug Information available for: Tedisamil Tedisamil sesquifumarate

U.S. FDA Resources

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 5
Pleven, Bulgaria
Site 2
Sofia, Bulgaria
Site 4
Sofia, Bulgaria
Site 6
Sofia, Bulgaria
Site 3
Sofia, Bulgaria
Site 7
Sofia, Bulgaria
Germany
Site 8
Mannheim, Germany
Hungary
Site 9
Budapest, Hungary
Site 12
Budapest, Hungary
Site 14
Budapest, Hungary
Site 15
Budapest, Hungary
Site 11
Budapest, Hungary
Site 13
Kecskemet, Hungary
Site 10
Korhaz, Hungary
Italy
Site 16
Piacenza, Italy
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, Poland

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00126074 History of Changes
Other Study ID Numbers:	S219.3.118, 2004-000346-21
Study First Received:	August 1, 2005
Last Updated:	March 24, 2006
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

Additional relevant MeSH terms:

Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Tedisamil

Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 13, 2012