Study to Evaluate the Safety of the Fixed-dose Combination Rosuvastatin/Ezetimibe for Patients With Dyslipidaemia (TREZETE)

Laboratorios Silanes

Status: Completed

Conditions: Dyslipidemias

Treatments: Drug: Rosuvastatin 10 or 20mg /Ezetimibe 10 mg Fixed Dose

Study type: Observational

Funder types: Industry

Identifiers

NCT04862962

SIL-30231-IV-20(1)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age> 18 years of age.
• Diagnosis of dyslipidemia.
• That treatment with the fixed-dose combination of rosuvastatin / ezetimibe is documented.
• Have security questioning on at least two occasions.

Exclusion criteria

• Subjects who has taken any other statins, fibrates, bile acid sequestrants, niacin (> 500 mg) or inhibitors of PCSK9 concomitantly during treatment with rosuvastatin / ezetimibe.

Trial design

120 participants in 1 patient group

Group A: Rosuvastatin /Ezetimibe fixed dose (TREZETE®)

Description:

Rosuvastatin /Ezetimibe fixed dose (TREZETE®) Pharmaceutical Form: Tablets Dosage: 10 mg / 10 mg or 20 mg / 10 mg Administration way: Oral

Treatment:

Drug: Rosuvastatin 10 or 20mg /Ezetimibe 10 mg Fixed Dose