Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Female 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 Female Subjects With Recent Onset Atrial Fibrillation or Flutter
2 other identifiers
interventional
N/A
6 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 female 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
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedJanuary 16, 2015
March 1, 2006
1.4 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
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Site 26
Honolulu, Hawaii, United States
Site 27
Tullahoma, Tennessee, United States
Site 5
Pleven, Bulgaria
Site 2
Sofia, Bulgaria
Site 3
Sofia, Bulgaria
Site 4
Sofia, Bulgaria
Site 6
Sofia, Bulgaria
Site 7
Sofia, Bulgaria
Site 8
Mannheim, Germany
Site 11
Budapest, Hungary
Site 12
Budapest, Hungary
Site 14
Budapest, Hungary
Site 15
Budapest, Hungary
Site 9
Budapest, Hungary
Site 13
Kecskemét, Hungary
Site 10
Korhaz, Hungary
Site 16
Piacenza, Italy
Site 22
Chrzanów, Poland
Site 20
Gdansk, Poland
Site 25
Gdynia, Poland
Site 19
Katowice, Poland
Site 18
Krakow, Poland
Site 24
Szczecin, Poland
Site 17
Tarnów, Poland
Site 23
Wałbrzych, Poland
Site 21
Zakopane, Poland
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
March 1, 2006
Study Completion
March 1, 2006
Last Updated
January 16, 2015
Record last verified: 2006-03