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
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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COMPLETED
PHASE3
INTERVENTIONAL
2004-12-31
2006-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Tedisamil sesquifumarate
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Solvay Pharmaceuticals
INDUSTRY
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
Site 2
Buenos Aires, , Argentina
Site 3
Buenos Aires, , Argentina
Site 5
Munro, , Argentina
Site 4
San Miguel de Tucumán, , Argentina
Site 8
Brno, , Czechia
Site 11
Jindřichův Hradec, , Czechia
Site 9
Ostrava-Poruba, , Czechia
Site 10
Pilsen, , Czechia
Site 14
Prague, , Czechia
Site 6
Prague, , Czechia
Site 7
Prague, , Czechia
Site 12
Slaný, , Czechia
Site 13
Ústí nad Orlicí, , Czechia
Site 15
Bad Nauheim, , Germany
Site 17
Göttingen, , Germany
Site 16
Halle, , Germany
Site 18
Haifa, , Israel
Site 19
Jerusalem, , Israel
Site 22
Jerusalem, , Israel
Site 23
Jerusalem, , Israel
Site 20
Tel Aviv, , Israel
Site 21
Tel Aviv, , Israel
Site 26
Bydgoszcz, , Poland
Site 32
Bydgoszcz, , Poland
Site 30
Lodz, , Poland
Site 29
Lublin, , Poland
Site 36
Lublin, , Poland
Site 31
Medyczna, , Poland
Site 33
Szczecin, , Poland
Site 24
Warsaw, , Poland
Site 25
Warsaw, , Poland
Site 27
Warsaw, , Poland
Site 28
Warsaw, , Poland
Site 34
Wroclaw, , Poland
Site 35
Wroclaw, , Poland
Site 38
Brasov, , Romania
Site 39
Bucharest, , Romania
Site 40
Bucharest, , Romania
Site 37
Tg. Mures, , Romania
Site 41
Moscow, , Russia
Site 42
Moscow, , Russia
Site 43
Moscow, , Russia
Site 44
Moscow, , Russia
Site 45
Moscow, , Russia
Site 46
Moscow, , Russia
Site 47
Moscow, , Russia
Site 48
Moscow, , Russia
Site 49
Moscow, , Russia
Site 51
Moscow, , Russia
Site 50
Saint Petersburg, , Russia
Site 52
Belgrade, , Serbia and Montenegro
Site 53
Belgrade, , Serbia and Montenegro
Site 54
Belgrade, , Serbia and Montenegro
Site 57
Belgrade, , Serbia and Montenegro
Site 58
Belgrade, , Serbia and Montenegro
Site 56
Niska Banja, , Serbia and Montenegro
Site 55
Sremska Kamenica, , Serbia and Montenegro
Site 60
Banská Bystrica, , Slovakia
Site 64
Bratislava, , Slovakia
Site 61
Košice, , Slovakia
Site 62
Lučenec, , Slovakia
Site 59
Nitra, , Slovakia
Site 65
Nové Zámky, , Slovakia
Site 63
Prešov, , Slovakia
Site 66
Cape Town, , South Africa
Site 67
Cape Town, , South Africa
Site 68
Dnipro, , Ukraine
Site 69
Dnipro, , Ukraine
Site 71
Donetsk, , Ukraine
Site 72
Donetsk, , Ukraine
Site 75
Kharkiv, , Ukraine
Site 70
Kiev, , Ukraine
Site 73
Kiev, , Ukraine
Site 76
Kiev, , Ukraine
Site 77
Kiev, , Ukraine
Site 74
Lviv, , Ukraine
Site 80
Odesa, , Ukraine
Site 79
Zaporizhya, , Ukraine
Site 78
Zaporizhzhya, , Ukraine
Site 81
London, , United Kingdom
Countries
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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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