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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04862962
Recruitment Status : Completed
First Posted : April 28, 2021
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
Laboratorios Silanes S.A. de C.V.

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Dyslipidemias Drug: Rosuvastatin 10 or 20mg /Ezetimibe 10 mg Fixed Dose

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 Design
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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official 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.
Actual Study Start Date : September 30, 2021
Actual Primary Completion Date : January 15, 2022
Actual Study Completion Date : February 15, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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 Name: (TREZETE®)


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04862962


Locations
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Mexico
Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico, 11000
Sponsors and Collaborators
Laboratorios Silanes S.A. de C.V.
Investigators
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Principal Investigator: Joel Rodriguez Saldaña, M.D Resultados Médicos, desarrollo e Investigación
Principal Investigator: Francisco G Padilla Padilla, M.D Independent
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
More Information
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Publications:

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Responsible Party: Laboratorios Silanes S.A. de C.V.
ClinicalTrials.gov Identifier: NCT04862962    
Other Study ID Numbers: SIL-30231-IV-20(1)
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laboratorios Silanes S.A. de C.V.:
Dyslipidemias
Combine therapy
Lower Cholesterol
Lipids
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Ezetimibe
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors