Clinical trial NCT00126061: Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Male 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 Male Subjects With Recent Onset Atrial Fibrillation or Flutter
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: MALE
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 male patients.


Eligibility criteria: Inclusion Criteria:

* Willing to sign informed consent before screening examinations are performed and before the study drug is administered
* 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:

* Acute myocardial infarction and cerebrovascular accidents
* Coronary and heart failure symptoms
* Life-threatening ventricular arrhythmias and electrocardiogram (ECG) abnormalities
* Electrolyte abnormalities
* Concurrent antiarrhythmic treatments

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Site 26
state: California
city: Santa Ana
country: United States
facility: Site 27
state: California
city: Honolulu
country: United States
facility: Site 24
state: Hawaii
city: Tullahoma
country: United States
facility: Site 25
state: Tennessee
city: Brno
country: Czech Republic
facility: Site 5
city: Plzen
country: Czech Republic
facility: Site 4
city: Prague
country: Czech Republic
facility: Site 2
city: Prague
country: Czech Republic
facility: Site 3
city: Prague
country: Czech Republic
facility: Site 6
city: Bydgoszcz
country: Poland
facility: Site 8
city: Lodz
country: Poland
facility: Site 11
city: Lublin
country: Poland
facility: Site 10
city: Medyczna
country: Poland
facility: Site 12
city: Warszawa
country: Poland
facility: Site 7
city: Warszawa
country: Poland
facility: Site 9
city: Moscow
country: Russian Federation
facility: Site 13
city: Moscow
country: Russian Federation
facility: Site 14
city: Moscow
country: Russian Federation
facility: Site 15
city: Moscow
country: Russian Federation
facility: Site 16
city: Moscow
country: Russian Federation
facility: Site 17
city: Dnepropetrovsk
country: Ukraine
facility: Site 20
city: Kiev
country: Ukraine
facility: Site 18
city: Kiev
country: Ukraine
facility: Site 21
city: Lviv
country: Ukraine
facility: Site 19
city: Odessa
country: Ukraine
facility: Site 23
city: Zaporozhye
country: Ukraine
facility: Site 22
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: