NCT07206472 A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
| NCT ID | NCT07206472 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Daiichi Sankyo |
| Condition | Primary Hypercholesterolaemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,120 participants |
| Start Date | 2026-03-03 |
| Primary Completion | 2028-11-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,120 participants in total. It began in 2026-03-03 with a primary completion date of 2028-11-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Global Team Lead
STUDY DIRECTOR
Daiichi Sankyo
Frequently Asked Questions
Who can join the NCT07206472 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Primary Hypercholesterolaemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07206472 currently recruiting?
Yes, NCT07206472 is actively recruiting participants. Contact the research team at CTRinfo_us@daiichisankyo.com for enrollment information.
Where is the NCT07206472 trial being conducted?
This trial is being conducted at Belo Horizonte, Brazil, Belo Horizonte, Brazil, Belo Horizonte, Brazil, Blumenau, Brazil and 11 additional locations.
Who is sponsoring the NCT07206472 clinical trial?
NCT07206472 is sponsored by Daiichi Sankyo. The principal investigator is Global Team Lead at Daiichi Sankyo. The trial plans to enroll 2,120 participants.