Laboratorio Silanes, S.A. de C.V.
Mexico City, 11000, Mexico
NCT Number: NCT04862962
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.
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Notify Me18 year and older
All sexes
Observational
Mexico City, 11000, Mexico
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral Tablets 10 mg/10 mg or 20 mg/10 mg
Other names: (TREZETE®)
Time frame: 2 months
Describe the frequency and intensity of adverse events presented.
Time frame: Baseline, 2 months
Evaluate the average difference in lipid profile values between at least 2 measurements.
Time frame: 2 months
To assess adherence to treatment with rosuvastatin / ezetimibe fixed-dose combination by pill count.
Time frame: 2 months
To assess the proportion of subjects who achieved a significant reduction in LDL cholesterol at each concentration of treatment.
Time frame: 2 months
To identify the percentage of patients who met the established goals according to cardiovascular risk determined by the European Society of Cardiology (ESC) and / or American Heart Association (AHA) / American College of Cardiology (ACC) recommendations.
Laboratorios Silanes S.A. de C.V.
Industry
Retrospective Study to Evaluate the Safety of the Fixed-dose Combination Rosuvastatin / Ezetimibe as a Treatment for Patients With Dyslipidaemia in Usual Medical Practice.
Acronym: TREZETE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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