A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
Recruiting · NCT07206472 · Observational (researchers observe without assigning treatment) · Lead sponsor: Daiichi Sankyo
View the official record on ClinicalTrials.gov →Interventions studied
Combination of bempedoic acid and ezetimibe
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
23 locations listed.
- 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
- The University of Hong Kong, Queen Mary Hospital - Hong Kong, Hong Kong
- CMEP Centro Multidisciplinar de Ensino Especializado e Pesquisa LTDA - Joinville, Brazil
- Galileo Medical Research Ltda. - Juiz de Fora, Brazil
- Hospital Parana - Parana Medical Research Center - Maringá, Brazil
- Hospital Maternidade e Pronto Socorro Santa Lucia - Pocos de Calda, Brazil
- Hospital Moinhos de Vento (HMV) - Porto Alegre, Brazil
- Fundacao Bahiana de Infectologia - Salvador, Brazil
- Hospital da Mater Dei Salvador - Salvador, Brazil
- Hospital E Maternidade Dr. Cristavao da Gama (HMCG) - Santo André, Brazil
- BP - A Beneficencia Portuguesa de Sao Paulo - São Paulo, Brazil
- Hospital Alemao Oswaldo Cruz (HAOC) - São Paulo, Brazil
- Instituto Conceive Ltda - São Paulo, Brazil
- Cardial Servicos Medicos Especializados - São Paulo, Brazil
- Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - InCor HCFMUSP - São Paulo, Brazil
- Universidade de Sao Paulo (USP) - Hospital das Clinicas da Faculdade de Medicina - São Paulo, Brazil
- Instituto de Molestias Cardiovasculares Tatui - Tatuí, Brazil