Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Female Subjects
NCT ID: NCT00126074
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
2006-03-31
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 26
Honolulu, Hawaii, United States
Site 27
Tullahoma, Tennessee, United States
Site 5
Pleven, , Bulgaria
Site 2
Sofia, , Bulgaria
Site 3
Sofia, , Bulgaria
Site 4
Sofia, , Bulgaria
Site 6
Sofia, , Bulgaria
Site 7
Sofia, , Bulgaria
Site 8
Mannheim, , Germany
Site 11
Budapest, , Hungary
Site 12
Budapest, , Hungary
Site 14
Budapest, , Hungary
Site 15
Budapest, , Hungary
Site 9
Budapest, , Hungary
Site 13
Kecskemét, , Hungary
Site 10
Korhaz, , Hungary
Site 16
Piacenza, , Italy
Site 22
Chrzanów, , Poland
Site 20
Gdansk, , Poland
Site 25
Gdynia, , Poland
Site 19
Katowice, , Poland
Site 18
Krakow, , Poland
Site 24
Szczecin, , Poland
Site 17
Tarnów, , Poland
Site 23
Wałbrzych, , Poland
Site 21
Zakopane, , Poland
Countries
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Other Identifiers
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2004-000346-21
Identifier Type: -
Identifier Source: secondary_id
S219.3.118
Identifier Type: -
Identifier Source: org_study_id
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