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: August 1, 2005 Last Updated: March 28, 2006 History of Changes

Sponsored by:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00126022

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:	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

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:

December 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: NCT00126022

Show 81 Study Locations

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	S219.3.116, 2004-000460-27
Study First Received:	August 1, 2005
Last Updated:	March 28, 2006
ClinicalTrials.gov Identifier:	NCT00126022 History of Changes
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Canada: Health Canada; Czech Republic: State Institute for Drug Control; Germany: Federal Institute for Drugs and Medical Devices; Israel: Israeli Health Ministry Pharmaceutical Administration; Poland: Ministry of Health; Romania: State Institute for Drug Control; Russia: Pharmacological Committee, Ministry of Health; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Slovakia: State Institute for Drug Control; South Africa: Medicines Control Council; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Ukraine: State Pharmacological Center - Ministry of Health; 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
Cardiovascular Agents
Anti-Arrhythmia Agents
Atrial Fibrillation

Atrial Flutter
Tedisamil
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Heart Diseases
Cardiotonic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Protective Agents
Atrial Flutter
Pharmacologic Actions

Tedisamil
Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Atrial Fibrillation
Anti-Arrhythmia Agents
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on September 10, 2009