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Completed

NCT Number: NCT04862962

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Laboratorio Silanes, S.A. de C.V.

Mexico City, 11000, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rosuvastatin 10 or 20mg /Ezetimibe 10 mg Fixed Dose

Drug

Oral Tablets 10 mg/10 mg or 20 mg/10 mg

Other names: (TREZETE®)

Primary outcomes

  1. Adverse events presented

    Time frame: 2 months

    Describe the frequency and intensity of adverse events presented.

  2. Average difference in lipid profile values

    Time frame: Baseline, 2 months

    Evaluate the average difference in lipid profile values between at least 2 measurements.

Secondary outcomes

  1. Adherence to treatment

    Time frame: 2 months

    To assess adherence to treatment with rosuvastatin / ezetimibe fixed-dose combination by pill count.

  2. Significant reduction in LDL cholesterol

    Time frame: 2 months

    To assess the proportion of subjects who achieved a significant reduction in LDL cholesterol at each concentration of treatment.

  3. Percentage of patients who met established goals according to cardiovascular risk

    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.

Sponsors and collaborators

Lead sponsor

Laboratorios Silanes S.A. de C.V.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 28, 2021
Registry last updated
Mar 2, 2022

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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