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Clinical Trial Summary

Retrospective, analytical, longitudinal, multicenter study to evaluate the safety of the fixed-dose combination of rosuvastatin / ezetimibe as treatment for patients with dyslipidemia in routine medical practice.


Clinical Trial Description

To assess the safety of the fixed-dose combination of rosuvastatin / ezetimibe in subjects older than 18 years of age (gender indistinct) with dyslipidemia who at the discretion have been candidates for treatment with the combination. For the safety analysis, all the research subjects who have taken rosuvastatin / ezetimibe will be considered. The information recorded by the treating physicians in the file will be reviewed and within the case report format (CRF) of all adverse events that occur in the study. The terms originally used in the case report format by the investigators to identify adverse events (AE) will be coded in the analysis stage of Results using the current MEdDRA dictionary. The incidence of AE will be synthesized such as the frequency count and percentage of research subjects with events adverse by organ / system. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04862962
Study type Observational
Source Laboratorios Silanes S.A. de C.V.
Contact Jorge A González, PhD
Phone 5254883785
Email [email protected]
Status Not yet recruiting
Phase
Start date May 2021
Completion date July 2021

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