Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Female Subjects
This study has been completed.
Sponsor:
Solvay Pharmaceuticals
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00126074
First received: August 1, 2005
Last updated: March 24, 2006
Last verified: March 2006
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation Atrial Flutter |
Drug: Tedisamil sesquifumarate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
U.S. FDA Resources
Further study details as provided by Solvay Pharmaceuticals:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00126074
Locations
| United States, Hawaii | |
| Site 26 | |
| Honolulu, Hawaii, United States | |
| United States, Tennessee | |
| Site 27 | |
| Tullahoma, Tennessee, United States | |
| Bulgaria | |
| Site 5 | |
| Pleven, Bulgaria | |
| Site 2 | |
| Sofia, Bulgaria | |
| Site 4 | |
| Sofia, Bulgaria | |
| Site 6 | |
| Sofia, Bulgaria | |
| Site 3 | |
| Sofia, Bulgaria | |
| Site 7 | |
| Sofia, Bulgaria | |
| Germany | |
| Site 8 | |
| Mannheim, Germany | |
| Hungary | |
| Site 9 | |
| Budapest, Hungary | |
| Site 15 | |
| Budapest, Hungary | |
| Site 14 | |
| Budapest, Hungary | |
| Site 12 | |
| Budapest, Hungary | |
| Site 11 | |
| Budapest, Hungary | |
| Site 13 | |
| Kecskemet, Hungary | |
| Site 10 | |
| Korhaz, Hungary | |
| Italy | |
| Site 16 | |
| Piacenza, Italy | |
| Poland | |
| Site 22 | |
| Chrzanow, Poland | |
| Site 20 | |
| Gdansk, Poland | |
| Site 25 | |
| Gdynia, Poland | |
| Site 19 | |
| Katowice, Poland | |
| Site 18 | |
| Krakow, Poland | |
| Site 24 | |
| Szczecin, Poland | |
| Site 17 | |
| Tarnow, Poland | |
| Site 23 | |
| Walbrzych, Poland | |
| Site 21 | |
| Zakopane, Poland | |
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
| Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00126074 History of Changes |
| Other Study ID Numbers: | S219.3.118, 2004-000346-21 |
| Study First Received: | August 1, 2005 |
| Last Updated: | March 24, 2006 |
| Health Authority: | Bulgaria: Bulgarian Drug Agency Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Italy: The Italian Medicines Agency Poland: Ministry of Health Spain: Spanish Agency of Medicines United States: Food and Drug Administration |
Keywords provided by Solvay Pharmaceuticals:
|
Atrial fibrillation, atrial flutter, anti-arrhythmic agents, conversion to normal sinus rhythm |
Additional relevant MeSH terms:
|
Atrial Fibrillation Atrial Flutter Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Tedisamil |
Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Cardiotonic Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013