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

NCT ID: NCT00126022

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

2004-12-31

Study Completion Date

2006-03-31

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 female 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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

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 82

Tullahoma, Tennessee, United States

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Site 2

Buenos Aires, , Argentina

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Site 3

Buenos Aires, , Argentina

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Site 5

Munro, , Argentina

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Site 4

San Miguel de Tucumán, , Argentina

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Site 8

Brno, , Czechia

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Site 11

Jindřichův Hradec, , Czechia

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Site 9

Ostrava-Poruba, , Czechia

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Site 10

Pilsen, , Czechia

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Site 14

Prague, , Czechia

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Site 6

Prague, , Czechia

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Site 7

Prague, , Czechia

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Site 12

Slaný, , Czechia

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Site 13

Ústí nad Orlicí, , Czechia

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Site 15

Bad Nauheim, , Germany

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Site 17

Göttingen, , Germany

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Site 16

Halle, , Germany

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Site 18

Haifa, , Israel

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Site 19

Jerusalem, , Israel

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Site 22

Jerusalem, , Israel

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Jerusalem, , Israel

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Site 20

Tel Aviv, , Israel

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Site 21

Tel Aviv, , Israel

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Site 26

Bydgoszcz, , Poland

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Site 32

Bydgoszcz, , Poland

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Site 30

Lodz, , Poland

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Site 29

Lublin, , Poland

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Site 36

Lublin, , Poland

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Site 31

Medyczna, , Poland

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Site 33

Szczecin, , Poland

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Site 24

Warsaw, , Poland

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Site 25

Warsaw, , Poland

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Site 27

Warsaw, , Poland

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Site 28

Warsaw, , Poland

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Site 34

Wroclaw, , Poland

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Site 35

Wroclaw, , Poland

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Site 38

Brasov, , Romania

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Site 39

Bucharest, , Romania

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Site 40

Bucharest, , Romania

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Site 37

Tg. Mures, , Romania

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Site 41

Moscow, , Russia

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Site 42

Moscow, , Russia

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Site 43

Moscow, , Russia

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Site 44

Moscow, , Russia

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Site 45

Moscow, , Russia

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Site 46

Moscow, , Russia

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Site 47

Moscow, , Russia

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Site 48

Moscow, , Russia

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Site 49

Moscow, , Russia

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Site 51

Moscow, , Russia

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Site 50

Saint Petersburg, , Russia

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Site 52

Belgrade, , Serbia and Montenegro

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Site 53

Belgrade, , Serbia and Montenegro

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Site 54

Belgrade, , Serbia and Montenegro

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Site 57

Belgrade, , Serbia and Montenegro

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Site 58

Belgrade, , Serbia and Montenegro

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Site 56

Niska Banja, , Serbia and Montenegro

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Site 55

Sremska Kamenica, , Serbia and Montenegro

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Site 60

Banská Bystrica, , Slovakia

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Site 64

Bratislava, , Slovakia

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Site 61

Košice, , Slovakia

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Site 62

Lučenec, , Slovakia

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Site 59

Nitra, , Slovakia

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Site 65

Nové Zámky, , Slovakia

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Site 63

Prešov, , Slovakia

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Site 66

Cape Town, , South Africa

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Site 67

Cape Town, , South Africa

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Site 68

Dnipro, , Ukraine

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Site 69

Dnipro, , Ukraine

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Site 71

Donetsk, , Ukraine

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Site 72

Donetsk, , Ukraine

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Site 75

Kharkiv, , Ukraine

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Site 70

Kiev, , Ukraine

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Site 73

Kiev, , Ukraine

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Site 76

Kiev, , Ukraine

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Site 77

Kiev, , Ukraine

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Site 74

Lviv, , Ukraine

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Site 80

Odesa, , Ukraine

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Site 79

Zaporizhya, , Ukraine

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Site 78

Zaporizhzhya, , Ukraine

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Site 81

London, , United Kingdom

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Countries

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United States Argentina Czechia Germany Israel Poland Romania Russia Serbia and Montenegro Slovakia South Africa Ukraine United Kingdom

Other Identifiers

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2004-000460-27

Identifier Type: -

Identifier Source: secondary_id

S219.3.116

Identifier Type: -

Identifier Source: org_study_id

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