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:
NCT00126022
First received: August 1, 2005
Last updated: March 28, 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 |
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: NCT00126022
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Hide Study LocationsLocations
| United States, Tennessee | |
| Site 82 | |
| Tullahoma, Tennessee, United States | |
| Argentina | |
| Site 2 | |
| Buenos Aires, Argentina | |
| Site 3 | |
| Buenos Aires, Argentina | |
| Site 5 | |
| Munro, Argentina | |
| Site 4 | |
| Tucuman, Argentina | |
| Czech Republic | |
| Site 8 | |
| Brno, Czech Republic | |
| Site 11 | |
| Jindrichuv Hradec, Czech Republic | |
| Site 9 | |
| Ostrava-Poruba, Czech Republic | |
| Site 10 | |
| Plzen, Czech Republic | |
| Site 6 | |
| Prague, Czech Republic | |
| Site 14 | |
| Prague, Czech Republic | |
| Site 7 | |
| Prague, Czech Republic | |
| Site 12 | |
| Slany, Czech Republic | |
| Site 13 | |
| Usti nad Orlici, Czech Republic | |
| Former Serbia and Montenegro | |
| Site 53 | |
| Belgrade, Former Serbia and Montenegro | |
| Site 57 | |
| Belgrade, Former Serbia and Montenegro | |
| Site 52 | |
| Belgrade, Former Serbia and Montenegro | |
| Site 54 | |
| Belgrade, Former Serbia and Montenegro | |
| Site 58 | |
| Belgrade, Former Serbia and Montenegro | |
| Site 56 | |
| Niska Banja, Former Serbia and Montenegro | |
| Site 55 | |
| Sremska Kamenica, Former Serbia and Montenegro | |
| Germany | |
| Site 15 | |
| Bad Nauheim, Germany | |
| Site 17 | |
| Gottingen, Germany | |
| Site 16 | |
| Halle, Germany | |
| Israel | |
| Site 18 | |
| Haifa, Israel | |
| Site 19 | |
| Jerusalem, Israel | |
| Site 22 | |
| Jerusalem, Israel | |
| Site 23 | |
| Jerusalem, Israel | |
| Site 21 | |
| Tel-Aviv, Israel | |
| Site 20 | |
| Tel-Aviv, Israel | |
| Poland | |
| Site 26 | |
| Bydgoszcz, Poland | |
| Site 32 | |
| Bydgoszcz, Poland | |
| Site 30 | |
| Lodz, Poland | |
| Site 29 | |
| Lublin, Poland | |
| Site 36 | |
| Lublin, Poland | |
| Site 31 | |
| Medyczna, Poland | |
| Site 33 | |
| Szczecin, Poland | |
| Site 25 | |
| Warszawa, Poland | |
| Site 27 | |
| Warszawa, Poland | |
| Site 28 | |
| Warszawa, Poland | |
| Site 24 | |
| Warszawa, Poland | |
| Site 34 | |
| Wroclaw, Poland | |
| Site 35 | |
| Wroclaw, Poland | |
| Romania | |
| Site 38 | |
| Brasov, Romania | |
| Site 40 | |
| Bucharest, Romania | |
| Site 39 | |
| Bucharest, Romania | |
| Site 37 | |
| Tg. Mures, Romania | |
| Russian Federation | |
| Site 48 | |
| Moscow, Russian Federation | |
| Site 49 | |
| Moscow, Russian Federation | |
| Site 43 | |
| Moscow, Russian Federation | |
| Site 51 | |
| Moscow, Russian Federation | |
| Site 44 | |
| Moscow, Russian Federation | |
| Site 45 | |
| Moscow, Russian Federation | |
| Site 42 | |
| Moscow, Russian Federation | |
| Site 47 | |
| Moscow, Russian Federation | |
| Site 46 | |
| Moscow, Russian Federation | |
| Site 41 | |
| Moscow, Russian Federation | |
| Site 50 | |
| St. Petersburg, Russian Federation | |
| Slovakia | |
| Site 60 | |
| Banska Bystrica, Slovakia | |
| Site 64 | |
| Bratislava, Slovakia | |
| Site 61 | |
| Kosice, Slovakia | |
| Site 62 | |
| Lucenec, Slovakia | |
| Site 59 | |
| Nitra, Slovakia | |
| Site 65 | |
| Nove Zamky, Slovakia | |
| Site 63 | |
| Presov, Slovakia | |
| South Africa | |
| Site 66 | |
| Cape Town, South Africa | |
| Site 67 | |
| Cape Town, South Africa | |
| Ukraine | |
| Site 68 | |
| Dnepropetrovsk, Ukraine | |
| Site 69 | |
| Dnepropetrovsk, Ukraine | |
| Site 71 | |
| Donetsk, Ukraine | |
| Site 72 | |
| Donetsk, Ukraine | |
| Site 75 | |
| Kharkiv, Ukraine | |
| Site 73 | |
| Kiev, Ukraine | |
| Site 70 | |
| Kiev, Ukraine | |
| Site 76 | |
| Kiev, Ukraine | |
| Site 77 | |
| Kiev, Ukraine | |
| Site 74 | |
| Lviv, Ukraine | |
| Site 80 | |
| Odessa, Ukraine | |
| Site 79 | |
| Zaporizhya, Ukraine | |
| Site 78 | |
| Zaporozhye, Ukraine | |
| United Kingdom | |
| Site 81 | |
| London, United Kingdom | |
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
| Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00126022 History of Changes |
| Other Study ID Numbers: | S219.3.116, 2004-000460-27 |
| Study First Received: | August 1, 2005 |
| Last Updated: | March 28, 2006 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Canada: Health Canada Czech Republic: State Institute for Drug Control Germany: Federal Institute for Drugs and Medical Devices Israel: Israeli Health Ministry Pharmaceutical Administration Poland: Ministry of Health Romania: State Institute for Drug Control Russia: Pharmacological Committee, Ministry of Health Serbia and Montenegro: Agency for Drugs and Medicinal Devices Slovakia: State Institute for Drug Control South Africa: Medicines Control Council United Kingdom: Medicines and Healthcare Products Regulatory Agency Ukraine: State Pharmacological Center - Ministry of Health 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 16, 2013