Status:
NOT_YET_RECRUITING
A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
Lead Sponsor:
Daiichi Sankyo
Conditions:
Primary Hypercholesterolaemia
Mixed Dyslipidemia
Eligibility:
All Genders
18+ years
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 conduct...
Detailed Description
The primary objective of this study is to describe patient characteristics and evaluate adverse drug reactions (ADRs) that occurred since initiation of bempedoic acid/FDC with ezetimibe and adverse ev...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 30 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
2560 Patients enrolled
Trial Details
Trial ID
NCT07206472
Start Date
January 30 2026
End Date
March 1 2029
Last Update
December 24 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.