Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Female Subjects
- Conditions
- Atrial FibrillationAtrial Flutter
- Registration Number
- NCT00126022
- Lead Sponsor
- Solvay Pharmaceuticals
- Brief Summary
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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (81)
Site 33
🇵🇱Szczecin, Poland
Site 37
🇷🇴Tg. Mures, Romania
Site 22
🇮🇱Jerusalem, Israel
Site 56
Niska Banja, Former Serbia and Montenegro
Site 15
🇩🇪Bad Nauheim, Germany
Site 38
🇷🇴Brasov, Romania
Site 30
🇵🇱Lodz, Poland
Site 29
🇵🇱Lublin, Poland
Site 35
🇵🇱Wroclaw, Poland
Site 16
🇩🇪Halle, Germany
Site 39
🇷🇴Bucharest, Romania
Site 24
🇵🇱Warszawa, Poland
Site 34
🇵🇱Wroclaw, Poland
Site 77
🇺🇦Kiev, Ukraine
Site 23
🇮🇱Jerusalem, Israel
Site 58
Belgrade, Former Serbia and Montenegro
Site 55
Sremska Kamenica, Former Serbia and Montenegro
Site 41
🇷🇺Moscow, Russian Federation
Site 46
🇷🇺Moscow, Russian Federation
Site 20
🇮🇱Tel-Aviv, Israel
Site 79
🇺🇦Zaporizhya, Ukraine
Site 60
🇸🇰Banska Bystrica, Slovakia
Site 27
🇵🇱Warszawa, Poland
Site 72
🇺🇦Donetsk, Ukraine
Site 42
🇷🇺Moscow, Russian Federation
Site 18
🇮🇱Haifa, Israel
Site 45
🇷🇺Moscow, Russian Federation
Site 48
🇷🇺Moscow, Russian Federation
Site 21
🇮🇱Tel-Aviv, Israel
Site 50
🇷🇺St. Petersburg, Russian Federation
Site 59
🇸🇰Nitra, Slovakia
Site 63
🇸🇰Presov, Slovakia
Site 17
🇩🇪Gottingen, Germany
Site 26
🇵🇱Bydgoszcz, Poland
Site 44
🇷🇺Moscow, Russian Federation
Site 47
🇷🇺Moscow, Russian Federation
Site 19
🇮🇱Jerusalem, Israel
Site 40
🇷🇴Bucharest, Romania
Site 43
🇷🇺Moscow, Russian Federation
Site 32
🇵🇱Bydgoszcz, Poland
Site 36
🇵🇱Lublin, Poland
Site 31
🇵🇱Medyczna, Poland
Site 25
🇵🇱Warszawa, Poland
Site 71
🇺🇦Donetsk, Ukraine
Site 28
🇵🇱Warszawa, Poland
Site 73
🇺🇦Kiev, Ukraine
Site 74
🇺🇦Lviv, Ukraine
Site 49
🇷🇺Moscow, Russian Federation
Site 68
🇺🇦Dnepropetrovsk, Ukraine
Site 64
🇸🇰Bratislava, Slovakia
Site 61
🇸🇰Kosice, Slovakia
Site 69
🇺🇦Dnepropetrovsk, Ukraine
Site 75
🇺🇦Kharkiv, Ukraine
Site 70
🇺🇦Kiev, Ukraine
Site 78
🇺🇦Zaporozhye, Ukraine
Site 62
🇸🇰Lucenec, Slovakia
Site 65
🇸🇰Nove Zamky, Slovakia
Site 2
🇦🇷Buenos Aires, Argentina
Site 82
🇺🇸Tullahoma, Tennessee, United States
Site 3
🇦🇷Buenos Aires, Argentina
Site 4
🇦🇷Tucuman, Argentina
Site 5
🇦🇷Munro, Argentina
Site 8
🇨🇿Brno, Czech Republic
Site 11
🇨🇿Jindrichuv Hradec, Czech Republic
Site 9
🇨🇿Ostrava-Poruba, Czech Republic
Site 10
🇨🇿Plzen, Czech Republic
Site 14
🇨🇿Prague, Czech Republic
Site 6
🇨🇿Prague, Czech Republic
Site 7
🇨🇿Prague, Czech Republic
Site 12
🇨🇿Slany, Czech Republic
Site 52
Belgrade, Former Serbia and Montenegro
Site 13
🇨🇿Usti nad Orlici, Czech Republic
Site 53
Belgrade, Former Serbia and Montenegro
Site 54
Belgrade, Former Serbia and Montenegro
Site 51
🇷🇺Moscow, Russian Federation
Site 57
Belgrade, Former Serbia and Montenegro
Site 81
🇬🇧London, United Kingdom
Site 66
🇿🇦Cape Town, South Africa
Site 67
🇿🇦Cape Town, South Africa
Site 80
🇺🇦Odessa, Ukraine
Site 76
🇺🇦Kiev, Ukraine