Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Female Subjects
Completed · Phase 3
Conditions studied: Atrial Fibrillation, Atrial Flutter
In brief
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.
Key facts
- Study ID
- NCT00126074
- Run by
- Solvay Pharmaceuticals
- Starts
- 2004-10-01
- Expected to finish
- 2006-03-01
- Last updated by the study team
- 2015-01-16
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
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
Where it is running
- 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
Full record on ClinicalTrials.gov
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