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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00126022
First Posted: August 2, 2005
Last Update Posted: January 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Solvay Pharmaceuticals
August 1, 2005
August 2, 2005
January 16, 2015
December 2004
March 2006   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00126022 on ClinicalTrials.gov Archive Site
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Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Female Subjects
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
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.
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Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Atrial Fibrillation
  • Atrial Flutter
Drug: Tedisamil sesquifumarate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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March 2006
March 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Czech Republic,   Former Serbia and Montenegro,   Germany,   Israel,   Poland,   Romania,   Russian Federation,   Slovakia,   South Africa,   Ukraine,   United Kingdom,   United States
 
 
NCT00126022
S219.3.116
2004-000460-27
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Solvay Pharmaceuticals
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Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
Solvay Pharmaceuticals
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP