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

Primary Purpose

Atrial Fibrillation, Atrial Flutter

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tedisamil sesquifumarate
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, atrial flutter, anti-arrhythmic agents, conversion to normal sinus rhythm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Site 82
  • Site 2
  • Site 3
  • Site 5
  • Site 4
  • Site 8
  • Site 11
  • Site 9
  • Site 10
  • Site 14
  • Site 6
  • Site 7
  • Site 12
  • Site 13
  • Site 52
  • Site 53
  • Site 54
  • Site 57
  • Site 58
  • Site 56
  • Site 55
  • Site 15
  • Site 17
  • Site 16
  • Site 18
  • Site 19
  • Site 22
  • Site 23
  • Site 20
  • Site 21
  • Site 26
  • Site 32
  • Site 30
  • Site 29
  • Site 36
  • Site 31
  • Site 33
  • Site 24
  • Site 25
  • Site 27
  • Site 28
  • Site 34
  • Site 35
  • Site 38
  • Site 39
  • Site 40
  • Site 37
  • Site 41
  • Site 42
  • Site 43
  • Site 44
  • Site 45
  • Site 46
  • Site 47
  • Site 48
  • Site 49
  • Site 51
  • Site 50
  • Site 60
  • Site 64
  • Site 61
  • Site 62
  • Site 59
  • Site 65
  • Site 63
  • Site 66
  • Site 67
  • Site 68
  • Site 69
  • Site 71
  • Site 72
  • Site 75
  • Site 70
  • Site 73
  • Site 76
  • Site 77
  • Site 74
  • Site 80
  • Site 79
  • Site 78
  • Site 81

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 1, 2005
Last Updated
January 15, 2015
Sponsor
Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00126022
Brief Title
Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Female Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Atrial Flutter
Keywords
Atrial fibrillation, atrial flutter, anti-arrhythmic agents, conversion to normal sinus rhythm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tedisamil sesquifumarate

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 82
City
Tullahoma
State/Province
Tennessee
Country
United States
Facility Name
Site 2
City
Buenos Aires
Country
Argentina
Facility Name
Site 3
City
Buenos Aires
Country
Argentina
Facility Name
Site 5
City
Munro
Country
Argentina
Facility Name
Site 4
City
Tucuman
Country
Argentina
Facility Name
Site 8
City
Brno
Country
Czech Republic
Facility Name
Site 11
City
Jindrichuv Hradec
Country
Czech Republic
Facility Name
Site 9
City
Ostrava-Poruba
Country
Czech Republic
Facility Name
Site 10
City
Plzen
Country
Czech Republic
Facility Name
Site 14
City
Prague
Country
Czech Republic
Facility Name
Site 6
City
Prague
Country
Czech Republic
Facility Name
Site 7
City
Prague
Country
Czech Republic
Facility Name
Site 12
City
Slany
Country
Czech Republic
Facility Name
Site 13
City
Usti nad Orlici
Country
Czech Republic
Facility Name
Site 52
City
Belgrade
Country
Former Serbia and Montenegro
Facility Name
Site 53
City
Belgrade
Country
Former Serbia and Montenegro
Facility Name
Site 54
City
Belgrade
Country
Former Serbia and Montenegro
Facility Name
Site 57
City
Belgrade
Country
Former Serbia and Montenegro
Facility Name
Site 58
City
Belgrade
Country
Former Serbia and Montenegro
Facility Name
Site 56
City
Niska Banja
Country
Former Serbia and Montenegro
Facility Name
Site 55
City
Sremska Kamenica
Country
Former Serbia and Montenegro
Facility Name
Site 15
City
Bad Nauheim
Country
Germany
Facility Name
Site 17
City
Gottingen
Country
Germany
Facility Name
Site 16
City
Halle
Country
Germany
Facility Name
Site 18
City
Haifa
Country
Israel
Facility Name
Site 19
City
Jerusalem
Country
Israel
Facility Name
Site 22
City
Jerusalem
Country
Israel
Facility Name
Site 23
City
Jerusalem
Country
Israel
Facility Name
Site 20
City
Tel-Aviv
Country
Israel
Facility Name
Site 21
City
Tel-Aviv
Country
Israel
Facility Name
Site 26
City
Bydgoszcz
Country
Poland
Facility Name
Site 32
City
Bydgoszcz
Country
Poland
Facility Name
Site 30
City
Lodz
Country
Poland
Facility Name
Site 29
City
Lublin
Country
Poland
Facility Name
Site 36
City
Lublin
Country
Poland
Facility Name
Site 31
City
Medyczna
Country
Poland
Facility Name
Site 33
City
Szczecin
Country
Poland
Facility Name
Site 24
City
Warszawa
Country
Poland
Facility Name
Site 25
City
Warszawa
Country
Poland
Facility Name
Site 27
City
Warszawa
Country
Poland
Facility Name
Site 28
City
Warszawa
Country
Poland
Facility Name
Site 34
City
Wroclaw
Country
Poland
Facility Name
Site 35
City
Wroclaw
Country
Poland
Facility Name
Site 38
City
Brasov
Country
Romania
Facility Name
Site 39
City
Bucharest
Country
Romania
Facility Name
Site 40
City
Bucharest
Country
Romania
Facility Name
Site 37
City
Tg. Mures
Country
Romania
Facility Name
Site 41
City
Moscow
Country
Russian Federation
Facility Name
Site 42
City
Moscow
Country
Russian Federation
Facility Name
Site 43
City
Moscow
Country
Russian Federation
Facility Name
Site 44
City
Moscow
Country
Russian Federation
Facility Name
Site 45
City
Moscow
Country
Russian Federation
Facility Name
Site 46
City
Moscow
Country
Russian Federation
Facility Name
Site 47
City
Moscow
Country
Russian Federation
Facility Name
Site 48
City
Moscow
Country
Russian Federation
Facility Name
Site 49
City
Moscow
Country
Russian Federation
Facility Name
Site 51
City
Moscow
Country
Russian Federation
Facility Name
Site 50
City
St. Petersburg
Country
Russian Federation
Facility Name
Site 60
City
Banska Bystrica
Country
Slovakia
Facility Name
Site 64
City
Bratislava
Country
Slovakia
Facility Name
Site 61
City
Kosice
Country
Slovakia
Facility Name
Site 62
City
Lucenec
Country
Slovakia
Facility Name
Site 59
City
Nitra
Country
Slovakia
Facility Name
Site 65
City
Nove Zamky
Country
Slovakia
Facility Name
Site 63
City
Presov
Country
Slovakia
Facility Name
Site 66
City
Cape Town
Country
South Africa
Facility Name
Site 67
City
Cape Town
Country
South Africa
Facility Name
Site 68
City
Dnepropetrovsk
Country
Ukraine
Facility Name
Site 69
City
Dnepropetrovsk
Country
Ukraine
Facility Name
Site 71
City
Donetsk
Country
Ukraine
Facility Name
Site 72
City
Donetsk
Country
Ukraine
Facility Name
Site 75
City
Kharkiv
Country
Ukraine
Facility Name
Site 70
City
Kiev
Country
Ukraine
Facility Name
Site 73
City
Kiev
Country
Ukraine
Facility Name
Site 76
City
Kiev
Country
Ukraine
Facility Name
Site 77
City
Kiev
Country
Ukraine
Facility Name
Site 74
City
Lviv
Country
Ukraine
Facility Name
Site 80
City
Odessa
Country
Ukraine
Facility Name
Site 79
City
Zaporizhya
Country
Ukraine
Facility Name
Site 78
City
Zaporozhye
Country
Ukraine
Facility Name
Site 81
City
London
Country
United Kingdom

12. IPD Sharing Statement

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

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