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

Tracking Information

First Received Date ^ICMJE

August 1, 2005

Last Updated Date

March 24, 2006

Start Date ^ICMJE

October 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00126074 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Atrial Fibrillation
Atrial Flutter

Intervention ^ICMJE

Drug: Tedisamil sesquifumarate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT ID ^ICMJE

NCT00126074

Responsible Party

Study ID Numbers ^ICMJE

S219.3.118, 2004-000346-21

Study Sponsor ^ICMJE

Solvay Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

Information Provided By

Solvay Pharmaceuticals

Verification Date

March 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP