Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Female Subjects

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00126022
First received: August 1, 2005
Last updated: March 28, 2006
Last verified: March 2006
  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:


Further study details as provided by Solvay Pharmaceuticals:

Study Start Date: December 2004
  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

  Hide Study Locations
Locations
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 April 16, 2014