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
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
2004-10-31
2006-01-31
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
* 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
* Coronary and heart failure symptoms
* Life-threatening ventricular arrhythmias and electrocardiogram (ECG) abnormalities
* Electrolyte abnormalities
* Concurrent antiarrhythmic treatments
18 Years
MALE
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 26
Los Angeles, California, United States
Site 27
Santa Ana, California, United States
Site 24
Honolulu, Hawaii, United States
Site 25
Tullahoma, Tennessee, United States
Site 5
Brno, , Czechia
Site 4
Pilsen, , Czechia
Site 2
Prague, , Czechia
Site 3
Prague, , Czechia
Site 6
Prague, , Czechia
Site 8
Bydgoszcz, , Poland
Site 11
Lodz, , Poland
Site 10
Lublin, , Poland
Site 12
Medyczna, , Poland
Site 7
Warsaw, , Poland
Site 9
Warsaw, , Poland
Site 13
Moscow, , Russia
Site 14
Moscow, , Russia
Site 15
Moscow, , Russia
Site 16
Moscow, , Russia
Site 17
Moscow, , Russia
Site 20
Dnipro, , Ukraine
Site 18
Kiev, , Ukraine
Site 21
Kiev, , Ukraine
Site 19
Lviv, , Ukraine
Site 23
Odesa, , Ukraine
Site 22
Zaporizhzhya, , Ukraine
Countries
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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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