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

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.
 
ClinicalTrials.gov Identifier: NCT00126022
Recruitment Status : Completed
First Posted : August 2, 2005
Last Update Posted : January 16, 2015
Sponsor:
Information provided by:
Solvay Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Atrial Flutter Drug: Tedisamil sesquifumarate Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : December 2004
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00126022


Locations
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Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
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Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
More Information
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ClinicalTrials.gov Identifier: NCT00126022    
Other Study ID Numbers: S219.3.116
2004-000460-27
First Posted: August 2, 2005    Key Record Dates
Last Update Posted: January 16, 2015
Last Verified: March 2006
Keywords provided by Solvay Pharmaceuticals:
Atrial fibrillation
atrial flutter
anti-arrhythmic agents
conversion to normal sinus rhythm
Additional relevant MeSH terms:
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Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
 Tedisamil
Anti-Arrhythmia Agents
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs