Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Male 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 Male Subjects With Recent Onset Atrial Fibrillation or Flutter
2 other identifiers
interventional
N/A
5 countries
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2004
Shorter than P25 for phase_3 atrial-fibrillation
26 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
October 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
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedJanuary 16, 2015
March 1, 2006
1.3 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
- 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)
You may not qualify if:
- Acute myocardial infarction and cerebrovascular accidents
- Coronary and heart failure symptoms
- Life-threatening ventricular arrhythmias and electrocardiogram (ECG) abnormalities
- Electrolyte abnormalities
- Concurrent antiarrhythmic treatments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Site 26
Los Angeles, California, United States
Site 27
Santa Ana, California, United States
Site 24
Honolulu, Hawaii, United States
Site 25
Tullahoma, Tennessee, United States
Site 5
Brno, Czechia
Site 4
Pilsen, Czechia
Site 2
Prague, Czechia
Site 3
Prague, Czechia
Site 6
Prague, Czechia
Site 8
Bydgoszcz, Poland
Site 11
Lodz, Poland
Site 10
Lublin, Poland
Site 12
Medyczna, Poland
Site 7
Warsaw, Poland
Site 9
Warsaw, Poland
Site 13
Moscow, Russia
Site 14
Moscow, Russia
Site 15
Moscow, Russia
Site 16
Moscow, Russia
Site 17
Moscow, Russia
Site 20
Dnipro, Ukraine
Site 18
Kiev, Ukraine
Site 21
Kiev, Ukraine
Site 19
Lviv, Ukraine
Site 23
Odesa, Ukraine
Site 22
Zaporizhzhya, Ukraine
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
October 1, 2004
Primary Completion
January 1, 2006
Study Completion
January 1, 2006
Last Updated
January 16, 2015
Record last verified: 2006-03