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COMPLETEDPhase 3NCT00126061

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

The purpose of this study is to demonstrate the ability of tedisamil to convert atrial fibrillation or flutter into normal sinus rhythm (NSR) in male patients.

Lead sponsor: Solvay Pharmaceuticals•4 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Solvay Pharmaceuticals

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

No

Inclusion Criteria

•Willing to sign informed consent before screening examinations are performed and before the study drug is administered
•Males \> 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

•Acute myocardial infarction and cerebrovascular accidents
•Coronary and heart failure symptoms
•Life-threatening ventricular arrhythmias and electrocardiogram (ECG) abnormalities
•Electrolyte abnormalities
•Concurrent antiarrhythmic treatments

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 16, 2015Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment—

Start dateOct 2004

Last updatedJan 16, 2015

Condition

Atrial Fibrillation Atrial Flutter

Locations shown

Site 26

Los Angeles, California

Site 27

Santa Ana, California

Site 24

Honolulu, Hawaii

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 16, 2015Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions