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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: |
NCT00259428 |
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Date of registration:
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25/11/2005 |
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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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EURopean Trial In Atrial Fibrillation(AF) or Flutter (AFL) Patients Receiving Dronedarone for the maIntenance of Sinus Rhythm (EURIDIS)
EURIDIS |
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Scientific title:
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EURopean Trial In Atrial Fibrillation or Flutter Patients Receiving Dronedarone for the maIntenance of Sinus Rhythm (EURIDIS) |
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Date of first enrolment:
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November 2001 |
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Target sample size:
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615 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00259428 |
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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: 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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Czech Republic
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Denmark
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Finland
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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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Spain
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United Kingdom
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Contacts
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Name:
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ICD Clinical study director (CSD) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients of either sex aged 21 years or more, in sinus rhythm for at least 1 hour at
the time of randomization and with at least one ECG-documented AF/AFL episode in the
last 3 months.
Exclusion Criteria:
- MAIN CRITERIA (non-exhaustive list, see protocol for details):
Women of childbearing potential without adequate birth control, Pregnant women,
Breastfeeding women, Congestive heart failure NYHA class III or IV, Conditions which
increase the risk of severe antiarrhythmic drug side effects, Severe associated
conditions.
Age minimum:
21 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Atrial Fibrillation
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Atrial Flutter
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Intervention(s)
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Drug: Dronedarone (SR33589)
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Drug: placebo
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Primary Outcome(s)
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The primary endpoint of the study is the time from randomisation to first documented AF/AFL recurrence
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Secondary Outcome(s)
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- mean ventricular rate during AF/AFL at first recorded AF/AFL recurrence (12-lead ECG or TTEM)
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- AF/AFL related symptoms collected at the time of ECG/TTEM recording,
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- time from presumed study drug near steady state defined as D5 midnight to first documented AF/AFL recurrence as indicated by ECG/TTEM recording.
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Secondary ID(s)
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SR33589B
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EFC3153
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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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