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Clinical Trials in Brazil / NCT07206472
Recruiting Observational

A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia

NCT07206472 · tracked via the Priya Life Science Brazil tracker
Phase
Observational
Started
2026-03-03
Last updated
2026-07-31

Condition(s) studied

Primary HypercholesterolaemiaMixed Dyslipidemia

Investigational drug(s) / intervention(s)

Combination of bempedoic acid and ezetimibe

Combination of bempedoic acid and ezetimibe: No drug was administered in this observational study.

Study summary

There is limited efficacy and safety data of bempedoic acid or its fixed dose combination (FDC) with ezetimibe in Asian and Latin American patients. This non-interventional study (NIS) will be conducted to characterize the risks and benefits of bempedoic acid or FDC with ezetimibe in a real-world clinical setting in adult patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Patients can be enrolled, when they fulfil the following inclusion criteria: * Written informed consent to participate. * At least 18 years of age. * Patients suffering from documented primary hypercholesterolemia or mixed dyslipidaemia treated or intended to be treated with bempedoic acid/ FDC with ezetimibe at the discretion of the physician are appropriate for participation in the observation. * For patients who are treated with bempedoic acid/FDC with ezetimibe prior to signed informed consent, initiation of bempedoic acid/FDC with ezetimibe must be within a maximum of three months prior to inclusion. * No contraindications exist according to the SmPC of bempedoic acid/FDC with ezetimibe. * No concurrent participation in an interventional study (simultaneous participation in other non-interventional study is possible) * Life expectancy \> 1 year. No explicit exclusion criteria exist to avoid selection bias and to allow for documentation of routine clinical practice.

Primary outcome measure(s)

Trial sites (23)

FacilityCityRegionStatus
Hospital Mater Dei Contorno Belo Horizonte Brazil Recruiting
Hospital Felício Rocho Belo Horizonte Brazil Recruiting
Hospital Vera Cruz Belo Horizonte Brazil Recruiting
Clinica Procardio Ltda. Blumenau Brazil Recruiting
Universidade de Caxias do Sul (UCS) Caixias Do Sul Brazil Recruiting
Hospital e Maternidade Angelina Caron Campina Grande do Sul Brazil Recruiting
Pontificia Universidade Catolica do Parana-(PUCPR) Curitiba Brazil Recruiting
CMEP Centro Multidisciplinar de Ensino Especializado e Pesquisa LTDA Joinville Brazil Recruiting
Galileo Medical Research Ltda. Juiz de Fora Brazil Recruiting
Hospital Parana - Parana Medical Research Center Maringá Brazil Recruiting
Hospital Maternidade e Pronto Socorro Santa Lucia Pocos de Calda Brazil Recruiting
Hospital Moinhos de Vento (HMV) Porto Alegre Brazil Recruiting
Fundacao Bahiana de Infectologia Salvador Brazil Recruiting
Hospital da Mater Dei Salvador Salvador Brazil Recruiting
Hospital E Maternidade Dr. Cristavao da Gama (HMCG) Santo André Brazil Recruiting
BP - A Beneficencia Portuguesa de Sao Paulo São Paulo Brazil Recruiting
Hospital Alemao Oswaldo Cruz (HAOC) São Paulo Brazil Recruiting
Instituto Conceive Ltda São Paulo Brazil Recruiting
Cardial Servicos Medicos Especializados São Paulo Brazil Recruiting
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - InCor HCFMUSP São Paulo Brazil Recruiting
Universidade de Sao Paulo (USP) - Hospital das Clinicas da Faculdade de Medicina São Paulo Brazil Recruiting
Instituto de Molestias Cardiovasculares Tatui Tatuí Brazil Recruiting
The University of Hong Kong, Queen Mary Hospital Hong Kong Hong Kong Recruiting

More Daiichi Sankyo trials in Brazil

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07206472 on ClinicalTrials.gov ↗ ← All trials in Brazil