Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Female Subjects
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety of Intravenous Tedisamil Sesquifumarate in the Rapid Conversion to Normal Sinus Rhythm in Female Subjects With Recent Onset Atrial Fibrillation
2 other identifiers
interventional
N/A
13 countries
81
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2004
Shorter than P25 for phase_3 atrial-fibrillation
81 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 1, 2005
CompletedFirst Posted
Study publicly available on registry
August 2, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedJanuary 16, 2015
March 1, 2006
1.2 years
August 1, 2005
January 15, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (81)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Director Solvay
Solvay Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 1, 2005
First Posted
August 2, 2005
Study Start
December 1, 2004
Primary Completion
March 1, 2006
Study Completion
March 1, 2006
Last Updated
January 16, 2015
Record last verified: 2006-03