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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00232310 |
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Date of registration:
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03/10/2005 |
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Primary sponsor: |
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Public title:
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Double Blind Placebo COntrolled Dose Ranging studY of the eFficacy and safEty of SSR149744c 300 or 600 mg for the Conversion of Atrial Fibrillation / fluttEr
CORYFEE |
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Scientific title:
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Double Blind Placebo Controlled Dose Ranging Study of the Efficacy and Safety of SSR149744C 300 or 600 mg for the Conversion of Atrial Fibrillation / Flutter |
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Date of first enrolment:
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October 2005 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00232310 |
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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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Countries of recruitment
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Canada
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Czech Republic
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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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Portugal
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United States
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Contacts
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Name:
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ICD 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-Aventis |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- AF/AFL for >72 hours and documented by 2 12-lead ECGs separated by at least 72 hours
and indication for electrical cardioversion of the current AF/AFL episode as judged
by the investigator.
Exclusion Criteria:
MAIN CRITERIA (non-exhaustive list):
- Women of childbearing potential without adequate birthcontrol, Pregnant Women,
Breastfeeding women, conditions which increase the risk of severe antiarrhythmic drug
side effects, permanent pacemaker, permanent AF/AFL, contraindication to
anticoagulant, severe left ventricular dysfunction, 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: CELIVARONE (SSR149744C)
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Primary Outcome(s)
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The primary efficacy endpoint is the rate of conversion to sinus rhythm documented by ECG just before the planned electrical cardioversion on D3 i.e. after 48 hours following the first study drug administration.
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Secondary Outcome(s)
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The secondary efficacy endpoint will be the mean ventricular rate during AF/AFL on the 12-lead ECG performed just before the planned electrical cardioversion on D3 i.e. after 48 hours following the first study drug administration.
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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