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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00035451 |
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Date of registration:
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03/05/2002 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.
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Scientific title:
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Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation. |
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Date of first enrolment:
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February 2001 |
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Target sample size:
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658 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00035451 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Belgium
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France
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Germany
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Hungary
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Italy
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Netherlands
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Poland
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Russian Federation
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Spain
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Contacts
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Name:
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Paloma Cuenca, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Procter and Gamble |
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Documented (12-lead ECG) history of symptomatic atrial fibrillation occurring between
48 hours and 6 months before screening
- Require the procedure of cardioversion (electric shock to correct abnormal rhythm)
- In the investigator's opinion, is likely to maintain sinus rhythm after
cardioversion.
- Be anticoagulated according to the recommendations of the Study Group on Atrial
Fibrillation of the European Society of Cardiology guidelines.
Exclusion criteria:
- Previously unsuccessful electrical cardioversions
- Failed to respond to any Class III antiarrhythmic drugs
- Qualifying arrhythmia due to acute reversible illness, acute myocardial infarction,
and/or cardiac or thoracic surgery within one month prior to randomization
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Atrial Fibrillation
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Intervention(s)
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Drug: Sotalol
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Drug: Placebo
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Drug: Azimilide Dihydrochloride
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Primary Outcome(s)
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To prolong the time to first symptomatic or asymptomatic AFIB, etc event
[Time Frame: 6 month]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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