Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Female Subjects
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ClinicalTrials.gov Identifier: NCT00126022 |
Recruitment Status
:
Completed
First Posted
: August 2, 2005
Last Update Posted
: January 16, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atrial Fibrillation Atrial Flutter | Drug: Tedisamil sesquifumarate | Phase 3 |
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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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

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

Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00126022 History of Changes |
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:
Atrial Fibrillation Atrial Flutter Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
Tedisamil Anti-Arrhythmia Agents Cardiotonic Agents Protective Agents Physiological Effects of Drugs |