search
Back to results

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 26
  • Site 27
  • Site 5
  • Site 2
  • Site 3
  • Site 4
  • Site 6
  • Site 7
  • Site 8
  • Site 11
  • Site 12
  • Site 14
  • Site 15
  • Site 9
  • Site 13
  • Site 10
  • Site 16
  • Site 22
  • Site 20
  • Site 25
  • Site 19
  • Site 18
  • Site 24
  • Site 17
  • Site 23
  • Site 21

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 1, 2005
Last Updated
January 15, 2015
Sponsor
Solvay Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00126074
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 or Flutter
Study Type
Interventional

2. Study Status

Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
October 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 26
City
Honolulu
State/Province
Hawaii
Country
United States
Facility Name
Site 27
City
Tullahoma
State/Province
Tennessee
Country
United States
Facility Name
Site 5
City
Pleven
Country
Bulgaria
Facility Name
Site 2
City
Sofia
Country
Bulgaria
Facility Name
Site 3
City
Sofia
Country
Bulgaria
Facility Name
Site 4
City
Sofia
Country
Bulgaria
Facility Name
Site 6
City
Sofia
Country
Bulgaria
Facility Name
Site 7
City
Sofia
Country
Bulgaria
Facility Name
Site 8
City
Mannheim
Country
Germany
Facility Name
Site 11
City
Budapest
Country
Hungary
Facility Name
Site 12
City
Budapest
Country
Hungary
Facility Name
Site 14
City
Budapest
Country
Hungary
Facility Name
Site 15
City
Budapest
Country
Hungary
Facility Name
Site 9
City
Budapest
Country
Hungary
Facility Name
Site 13
City
Kecskemet
Country
Hungary
Facility Name
Site 10
City
Korhaz
Country
Hungary
Facility Name
Site 16
City
Piacenza
Country
Italy
Facility Name
Site 22
City
Chrzanow
Country
Poland
Facility Name
Site 20
City
Gdansk
Country
Poland
Facility Name
Site 25
City
Gdynia
Country
Poland
Facility Name
Site 19
City
Katowice
Country
Poland
Facility Name
Site 18
City
Krakow
Country
Poland
Facility Name
Site 24
City
Szczecin
Country
Poland
Facility Name
Site 17
City
Tarnow
Country
Poland
Facility Name
Site 23
City
Walbrzych
Country
Poland
Facility Name
Site 21
City
Zakopane
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs