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

February 28, 2022 updated by: Laboratorios Silanes S.A. de C.V.

Retrospective Study to Evaluate the Safety of the Fixed-dose Combination Rosuvastatin / Ezetimibe as a Treatment for Patients With Dyslipidaemia in Usual Medical Practice.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 11000
        • Laboratorio Silanes, S.A. de C.V.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects over 18 years of age (gender indistinct) with dyslipidemia who, at the discretion of thetreating physician have been candidates for treatment with the fixed-dose combination of rosuvastatin-ezetimibe.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group A: Rosuvastatin /Ezetimibe fixed dose (TREZETE®)
Rosuvastatin /Ezetimibe fixed dose (TREZETE®) Pharmaceutical Form: Tablets Dosage: 10 mg / 10 mg or 20 mg / 10 mg Administration way: Oral
Drug: Rosuvastatin 10 or 20mg /Ezetimibe 10 mg Fixed Dose
Oral Tablets 10 mg/10 mg or 20 mg/10 mg
Other Names:
  • (TREZETE®)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse events presented
Time Frame: 2 months
Describe the frequency and intensity of adverse events presented.
2 months
Average difference in lipid profile values
Time Frame: Baseline, 2 months
Evaluate the average difference in lipid profile values between at least 2 measurements.
Baseline, 2 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adherence to treatment
Time Frame: 2 months
To assess adherence to treatment with rosuvastatin / ezetimibe fixed-dose combination by pill count.
2 months
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.
2 months
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.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laboratorios Silanes S.A. de C.V.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Francisco G Padilla Padilla, M.D, Independent
  • Principal Investigator: Joel Rodriguez Saldaña, M.D, Resultados Médicos, desarrollo e Investigación
  • Principal Investigator: Ernesto G Cardona Muñoz, M.D, Independent
  • Principal Investigator: David Cardona Müller, M.D, Independent
  • Principal Investigator: Marcos Ibarra Flores, M.D, Cardiólogos Certificados S.C
  • Principal Investigator: José A Estrada Suarez, M.D, Independent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SIL-30231-IV-20(1)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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