Phase 4
Completed N=30
Concentrations of Amiodarone in Fat Tissue During Chronic Treatment
Source: ClinicalTrials.gov NCT00313443 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2009
Primary outcomePrimary: Relationship Between Amiodarone Concentration in Fat Tissue and Cumulated Dose. — 0.20 Correlation coefficient R
Summary
The objective of this study is to determine if concentrations of amiodarone in fat tissue increases constantly over time during chronic treatment with this drug, and if blood concentrations reflect accurately the concentrations in fat tissue or not. This is because excessive concentrations of this drug in tissues can produce adverse effects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relationship Between Amiodarone Concentration in Fat Tissue and Cumulated Dose. |
0.20 | — |
| PRIMARY Relationship Between Amiodarone Concentrations in Fat Tissue and in Plasma. |
0.68 | — |
| PRIMARY Relationship Between Amiodarone Concentrations in Fat Tissue and Developing Adverse Effects. |
1.01 | — |
| SECONDARY Pain and Complications (if Any) Caused by Fat Tissue Needle Aspirations |
2 | — |
| SECONDARY Presence of Any Adverse Effect Attributable to Amiodarone. |
11 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00313443). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.