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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 October 2017 |
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Main ID: |
NCT00313443 |
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Date of registration:
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10/04/2006 |
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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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Concentrations of Amiodarone in Fat Tissue During Chronic Treatment
ATACA |
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Scientific title:
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Study of Concentrations of Amiodarone in Fat Tissue Obtained by Needle Aspiration in Patients on Chronic Treatment |
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Date of first enrolment:
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April 2006 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00313443 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Jean-Francois Bergmann, 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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Hopital Lariboisiere, Internal Medicine "A" Service, Paris |
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Name:
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Carmelo Lafuente-Lafuente, 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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Hopital Lariboisière, Internal Medicine "A" Service, Paris |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult patients taking amiodarone for more than 3 months (any dose, any indication)
Exclusion Criteria:
- Impossibility to perform needle aspiration of abdominal wall (local infection, skin
disease)
- Coagulation disorders, INR > 3.0 if warfarin treatment
- Patient unable to give informed consent
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Arrhythmia
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Atrial Flutter
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Atrial Fibrillation
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Intervention(s)
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Procedure: Fat tissue needle aspiration
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Primary Outcome(s)
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Relationship Between Amiodarone Concentration in Fat Tissue and Cumulated Dose.
[Time Frame: One single measure]
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Relationship Between Amiodarone Concentrations in Fat Tissue and Developing Adverse Effects.
[Time Frame: Cumulated time on amiodarone (varies in each patient)]
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Relationship Between Amiodarone Concentrations in Fat Tissue and in Plasma.
[Time Frame: One single measure, taken just before daily administration]
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Secondary Outcome(s)
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Presence of Any Adverse Effect Attributable to Amiodarone.
[Time Frame: Cumulated time on amiodarone (varies in each patient)]
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Pain and Complications (if Any) Caused by Fat Tissue Needle Aspirations
[Time Frame: 24 hours after needle aspiration]
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Secondary ID(s)
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ATACA-URT04/06
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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