Clinical trial NCT00126074: 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 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: 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: Honolulu
country: United States
facility: Site 26
state: Hawaii
city: Tullahoma
country: United States
facility: Site 27
state: Tennessee
city: Pleven
country: Bulgaria
facility: Site 5
city: Sofia
country: Bulgaria
facility: Site 2
city: Sofia
country: Bulgaria
facility: Site 3
city: Sofia
country: Bulgaria
facility: Site 4
city: Sofia
country: Bulgaria
facility: Site 6
city: Sofia
country: Bulgaria
facility: Site 7
city: Mannheim
country: Germany
facility: Site 8
city: Budapest
country: Hungary
facility: Site 11
city: Budapest
country: Hungary
facility: Site 12
city: Budapest
country: Hungary
facility: Site 14
city: Budapest
country: Hungary
facility: Site 15
city: Budapest
country: Hungary
facility: Site 9
city: Kecskemet
country: Hungary
facility: Site 13
city: Korhaz
country: Hungary
facility: Site 10
city: Piacenza
country: Italy
facility: Site 16
city: Chrzanow
country: Poland
facility: Site 22
city: Gdansk
country: Poland
facility: Site 20
city: Gdynia
country: Poland
facility: Site 25
city: Katowice
country: Poland
facility: Site 19
city: Krakow
country: Poland
facility: Site 18
city: Szczecin
country: Poland
facility: Site 24
city: Tarnow
country: Poland
facility: Site 17
city: Walbrzych
country: Poland
facility: Site 23
city: Zakopane
country: Poland
facility: Site 21
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: