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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: |
NCT01430806 |
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Date of registration:
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07/09/2011 |
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Primary sponsor: |
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Public title:
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Dronaderone to Prevent Recurrent Implantable Cardioverter Defibrillator (ICD) Shocks
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Scientific title:
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Dronedarone for Patients With Recurrent ICD Shocks Due to Ventricular Arrhythmia Resistant to Their Antiarrhythmic Drug Therapy or Ablation |
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Date of first enrolment:
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October 2011 |
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Target sample size:
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20 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01430806 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Recurernt ICD shocks depite other antiarrhythmic drug therapy
Exclusion Criteria:
- CHF NYHA IV OR DECMPENSATED III
- PERMANENT AF
- LIVER DYSFUNCION
- CR CLEARANCE <30
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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DRONEDARONE
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ICD
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ICD SHOCKS
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Intervention(s)
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Drug: Dronedarone
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Drug: Dronedarone arm
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Primary Outcome(s)
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Number of ICD shocks due to VT in the 6 months period after starting Dronedarone
[Time Frame: 1 year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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