Back to resultsIntravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Male Subjects
Primary Purpose
Atrial Fibrillation, Atrial Flutter
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tedisamil sesquifumarate
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, atrial flutter, anti-arrhythmic agents, conversion to normal sinus rhythm
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
Sites / Locations
- Site 26
- Site 27
- Site 24
- Site 25
- Site 5
- Site 4
- Site 2
- Site 3
- Site 6
- Site 8
- Site 11
- Site 10
- Site 12
- Site 7
- Site 9
- Site 13
- Site 14
- Site 15
- Site 16
- Site 17
- Site 20
- Site 18
- Site 21
- Site 19
- Site 23
- Site 22
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00126061
First Posted
August 1, 2005
Last Updated
January 15, 2015
Sponsor
Solvay Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00126061
Brief Title
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
2. Study Status
Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Solvay Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Atrial Flutter
Keywords
Atrial fibrillation, atrial flutter, anti-arrhythmic agents, conversion to normal sinus rhythm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tedisamil sesquifumarate
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 26
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Site 27
City
Santa Ana
State/Province
California
Country
United States
Facility Name
Site 24
City
Honolulu
State/Province
Hawaii
Country
United States
Facility Name
Site 25
City
Tullahoma
State/Province
Tennessee
Country
United States
Facility Name
Site 5
City
Brno
Country
Czech Republic
Facility Name
Site 4
City
Plzen
Country
Czech Republic
Facility Name
Site 2
City
Prague
Country
Czech Republic
Facility Name
Site 3
City
Prague
Country
Czech Republic
Facility Name
Site 6
City
Prague
Country
Czech Republic
Facility Name
Site 8
City
Bydgoszcz
Country
Poland
Facility Name
Site 11
City
Lodz
Country
Poland
Facility Name
Site 10
City
Lublin
Country
Poland
Facility Name
Site 12
City
Medyczna
Country
Poland
Facility Name
Site 7
City
Warszawa
Country
Poland
Facility Name
Site 9
City
Warszawa
Country
Poland
Facility Name
Site 13
City
Moscow
Country
Russian Federation
Facility Name
Site 14
City
Moscow
Country
Russian Federation
Facility Name
Site 15
City
Moscow
Country
Russian Federation
Facility Name
Site 16
City
Moscow
Country
Russian Federation
Facility Name
Site 17
City
Moscow
Country
Russian Federation
Facility Name
Site 20
City
Dnepropetrovsk
Country
Ukraine
Facility Name
Site 18
City
Kiev
Country
Ukraine
Facility Name
Site 21
City
Kiev
Country
Ukraine
Facility Name
Site 19
City
Lviv
Country
Ukraine
Facility Name
Site 23
City
Odessa
Country
Ukraine
Facility Name
Site 22
City
Zaporozhye
Country
Ukraine
12. IPD Sharing Statement
Learn more about this trial
Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Male Subjects
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