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

Recruitingn/aAges 18 Years - anyAllDaiichi Sankyo
NCT07206472 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Combination of bempedoic acid and ezetimibe
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Where

38 sites
Hospital Mater Dei Contorno
Belo Horizonte, Brazil
Hospital Felício Rocho
Belo Horizonte, Brazil
Hospital Vera Cruz
Belo Horizonte, Brazil
Clinica Procardio Ltda.
Blumenau, Brazil
Universidade de Caxias do Sul (UCS)
Caixias Do Sul, Brazil
Hospital e Maternidade Angelina Caron
Campina Grande do Sul, Brazil
Pontificia Universidade Catolica do Parana-(PUCPR)
Curitiba, Brazil
CMEP Centro Multidisciplinar de Ensino Especializado e Pesquisa LTDA
Joinville, Brazil

…and 30 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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