Clinical trial NCT00126022: Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Female Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Atrial Flutter
Keywords: Atrial fibrillation
atrial flutter
anti-arrhythmic agents
conversion to normal sinus rhythm
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-08-02
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tullahoma
country: United States
facility: Site 82
state: Tennessee
city: Buenos Aires
country: Argentina
facility: Site 2
city: Buenos Aires
country: Argentina
facility: Site 3
city: Munro
country: Argentina
facility: Site 5
city: Tucuman
country: Argentina
facility: Site 4
city: Brno
country: Czech Republic
facility: Site 8
city: Jindrichuv Hradec
country: Czech Republic
facility: Site 11
city: Ostrava-Poruba
country: Czech Republic
facility: Site 9
city: Plzen
country: Czech Republic
facility: Site 10
city: Prague
country: Czech Republic
facility: Site 14
city: Prague
country: Czech Republic
facility: Site 6
city: Prague
country: Czech Republic
facility: Site 7
city: Slany
country: Czech Republic
facility: Site 12
city: Usti nad Orlici
country: Czech Republic
facility: Site 13
city: Belgrade
country: Former Serbia and Montenegro
facility: Site 52
city: Belgrade
country: Former Serbia and Montenegro
facility: Site 53
city: Belgrade
country: Former Serbia and Montenegro
facility: Site 54
city: Belgrade
country: Former Serbia and Montenegro
facility: Site 57
city: Belgrade
country: Former Serbia and Montenegro
facility: Site 58
city: Niska Banja
country: Former Serbia and Montenegro
facility: Site 56
city: Sremska Kamenica
country: Former Serbia and Montenegro
facility: Site 55
city: Bad Nauheim
country: Germany
facility: Site 15
city: Gottingen
country: Germany
facility: Site 17
city: Halle
country: Germany
facility: Site 16
city: Haifa
country: Israel
facility: Site 18
city: Jerusalem
country: Israel
facility: Site 19
city: Jerusalem
country: Israel
facility: Site 22
city: Jerusalem
country: Israel
facility: Site 23
city: Tel-Aviv
country: Israel
facility: Site 20
city: Tel-Aviv
country: Israel
facility: Site 21
city: Bydgoszcz
country: Poland
facility: Site 26
city: Bydgoszcz
country: Poland
facility: Site 32
city: Lodz
country: Poland
facility: Site 30
city: Lublin
country: Poland
facility: Site 29
city: Lublin
country: Poland
facility: Site 36
city: Medyczna
country: Poland
facility: Site 31
city: Szczecin
country: Poland
facility: Site 33
city: Warszawa
country: Poland
facility: Site 24
city: Warszawa
country: Poland
facility: Site 25
city: Warszawa
country: Poland
facility: Site 27
city: Warszawa
country: Poland
facility: Site 28
city: Wroclaw
country: Poland
facility: Site 34
city: Wroclaw
country: Poland
facility: Site 35
city: Brasov
country: Romania
facility: Site 38
city: Bucharest
country: Romania
facility: Site 39
city: Bucharest
country: Romania
facility: Site 40
city: Tg. Mures
country: Romania
facility: Site 37
city: Moscow
country: Russian Federation
facility: Site 41
city: Moscow
country: Russian Federation
facility: Site 42
city: Moscow
country: Russian Federation
facility: Site 43
city: Moscow
country: Russian Federation
facility: Site 44
city: Moscow
country: Russian Federation
facility: Site 45
city: Moscow
country: Russian Federation
facility: Site 46
city: Moscow
country: Russian Federation
facility: Site 47
city: Moscow
country: Russian Federation
facility: Site 48
city: Moscow
country: Russian Federation
facility: Site 49
city: Moscow
country: Russian Federation
facility: Site 51
city: St. Petersburg
country: Russian Federation
facility: Site 50
city: Banska Bystrica
country: Slovakia
facility: Site 60
city: Bratislava
country: Slovakia
facility: Site 64
city: Kosice
country: Slovakia
facility: Site 61
city: Lucenec
country: Slovakia
facility: Site 62
city: Nitra
country: Slovakia
facility: Site 59
city: Nove Zamky
country: Slovakia
facility: Site 65
city: Presov
country: Slovakia
facility: Site 63
city: Cape Town
country: South Africa
facility: Site 66
city: Cape Town
country: South Africa
facility: Site 67
city: Dnepropetrovsk
country: Ukraine
facility: Site 68
city: Dnepropetrovsk
country: Ukraine
facility: Site 69
city: Donetsk
country: Ukraine
facility: Site 71
city: Donetsk
country: Ukraine
facility: Site 72
city: Kharkiv
country: Ukraine
facility: Site 75
city: Kiev
country: Ukraine
facility: Site 70
city: Kiev
country: Ukraine
facility: Site 73
city: Kiev
country: Ukraine
facility: Site 76
city: Kiev
country: Ukraine
facility: Site 77
city: Lviv
country: Ukraine
facility: Site 74
city: Odessa
country: Ukraine
facility: Site 80
city: Zaporizhya
country: Ukraine
facility: Site 79
city: Zaporozhye
country: Ukraine
facility: Site 78
city: London
country: United Kingdom
facility: Site 81
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: