NCT05798390Withdrawn
Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe in Routine Clinical Practice in Patients With Primary Hypercholesterolemia Or Mixed Dyslipidemia
Non-Interventional Study On The Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe in Routine Clinical Practice in Patients With Primary Hypercholesterolemia Or Mixed Dyslipidemia
Source: ClinicalTrials.gov · Last updated 6 Dec 2023
Reason given: Due to patient availability
Brief summary (registry, in English)
Cardiovascular disease (CVD), especially its management and associated costs, remains a major concern globally. There is a direct correlation between circulating levels of low-density lipoprotein cholesterol (LDL-C) and the incidence of CVD. This study will assess bempedoic acid/FDC in a real-world clinical setting in adult patients in Spain with hypercholesterolaemia or mixed dyslipidemia.
- Status (registry)
- Withdrawn
- Study type
- Observational
- Enrollment
- 0 (actual)
- First submitted
- 10 Mar 2023
- Start date
- 1 Sept 2023
- Primary completion date
- 1 Apr 2026
- Lead sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT05798390
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- As this is a non-interventional study, no explicit exclusion criteria exist in order to avoid selection bias and to allow for documentation of routine clinical practice.
Who the study is looking for
- Written informed consent to participate
- At least 18 years of age
- Participants suffering from documented primary hypercholesterolemia or mixed dyslipidemia
- Part 1: For participants treated to a maximum of 6 months or intended to be treated with bempedoic acid/FDC under usual clinical practice conditions and as long as the decision of the physician to start treatment is prior to the inclusion of the participant in the study at the discretion of the physician under no reimbursement conditions at enrollment
- Part 2: For participants treated or intended to be treated with bempedoic acid/FDC under usual clinical practice conditions and as long as the decision of the physician to start treatment is prior to the inclusion of the patient in the study under reimbursed conditions at enrollment
- No contraindications exist according to the SmPC of bempedoic acid/ FDC
- No concurrent participation in an interventional study (Simultaneous participation in other non-interventional studies is possible)
- Life expectancy > 1 -year
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.