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

NCT ID: NCT00126061

Last Updated: 2015-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation Atrial Flutter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tedisamil sesquifumarate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Solvay Pharmaceuticals

INDUSTRY

Sponsor Role lead

Principal Investigators

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Global Clinical Director Solvay

Role: STUDY_DIRECTOR

Solvay Pharmaceuticals

Locations

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Site 26

Los Angeles, California, United States

Site Status

Site 27

Santa Ana, California, United States

Site Status

Site 24

Honolulu, Hawaii, United States

Site Status

Site 25

Tullahoma, Tennessee, United States

Site Status

Site 5

Brno, , Czechia

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Site 4

Pilsen, , Czechia

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Site 2

Prague, , Czechia

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Site 3

Prague, , Czechia

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Site 6

Prague, , Czechia

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Site 8

Bydgoszcz, , Poland

Site Status

Site 11

Lodz, , Poland

Site Status

Site 10

Lublin, , Poland

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Site 12

Medyczna, , Poland

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Site 7

Warsaw, , Poland

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Site 9

Warsaw, , Poland

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Site 13

Moscow, , Russia

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Site 14

Moscow, , Russia

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Site 15

Moscow, , Russia

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Site 16

Moscow, , Russia

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Site 17

Moscow, , Russia

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Site 20

Dnipro, , Ukraine

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Site 18

Kiev, , Ukraine

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Site 21

Kiev, , Ukraine

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Site 19

Lviv, , Ukraine

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Site 23

Odesa, , Ukraine

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Site 22

Zaporizhzhya, , Ukraine

Site Status

Countries

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United States Czechia Poland Russia Ukraine

Other Identifiers

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2004-000458-22

Identifier Type: -

Identifier Source: secondary_id

S219.3.117

Identifier Type: -

Identifier Source: org_study_id

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