Primary HypercholesterolemiaMILOS-SpainNCT05798390
Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe in Routine Clinical Practice in Patients With Primary Hypercholesterolemia Or Mixed Dyslipidemia
An observational study of Primary Hypercholesterolemia and Mixed Dyslipidemia, run by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Hypercholesterolemia, Mixed Dyslipidemia
- What is being tested?
- Bempedoic acid and/or its fixed dose combination with ezetimibe
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of 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 no reimbursement conditions (Part 1) or under reimbursed conditions (Part 2) at enrollment and who are unable to reach their LDL-C goals with the maximum tolerated dose of statins or patients who are determined by their treating physician to be statin intolerant.
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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
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.
Read the detailed description
This non-interventional study will be conducted in order to further understand the potential risks and benefits of bempedoic acid/fixed dose combination (FDC) with ezetimibe in a real-world clinical setting in adult patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia and to gain insight into the effectiveness (managing plasma levels of LDL-C) as well as safety (clinical events associated with the treatment modalities). No study medication will be provided as part of this protocol to the patients. Medications will be as prescribed by the treating physician in line with clinical practice.
- Conditions
- Primary Hypercholesterolemia, Mixed Dyslipidemia
- Being tested
- Bempedoic acid and/or its fixed dose combination with ezetimibe
- Keywords
- Primary Hypercholesterolemia, Mixed Dyslipidemia, Bempedoic acid and/or its fixed-dose combination with ezetimibe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bempedoic acid and/or its fixed dose combination with ezetimibeDrug
This is a non-interventional study. No study medication will be provided as part of this protocol to the patients. Medications will be as prescribed by the treating physician in line with clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Bempedoic acid and/or fixed-dose combination with ezetimibe | Participants with primary hypercholesterolemia or mixed dyslipidemia who received bempedoic acid and/or its fixed-dose combination with ezetimibe. Receives: Drug: Bempedoic acid and/or its fixed dose combination with ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary of Patient Characteristics in Participants With Primary Hypercholesterolaemia or Mixed Dyslipidaemia Following Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe
Measured: Baseline up to 12 months
Secondary outcomes (17)
Mean Change From Baseline in Systematic Coronary Risk Estimation (SCORE) System Following Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe
Measured: Baseline up to 12 months
Mean Change From Baseline in Second Manifestations of Arterial Disease (SMART) Score Following Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe
Measured: Baseline up to 12 months
Mean Change From Baseline in Framingham Risk Score Following Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe
Measured: Baseline up to 12 months
Mean Change From Baseline in Low-density Lipoprotein Cholesterol Levels
Measured: Baseline up to 12 months
Mean Change From Baseline in Atherosclerotic Cardiovascular Disease-Modifying Cholesterol Fragments Levels
Measured: Baseline up to 12 months
Mean Change From Baseline in Inflammatory Marker hsCRP Levels
Measured: Baseline up to 12 months
Mean Change From Baseline In Uric Acid Levels
Measured: Baseline up to 12 months
Number of Participants With Relevant Cardiovascular (CV) Events
Measured: Baseline up to 12 months
Number of Participants With Adverse Effects and Adverse Drug Reactions Associated With Bempedoic Acid/FDC Ezetimibe
Measured: Baseline up to 12 months
Types of Practitioners Caring for Patients Treated With Bempedoic acid/ FDC with Ezetimibe
Measured: Baseline up to 12 months
Number of Participants Who Reported Use of Lipid-modifying Treatments Prior To Or Concomitantly To Receiving Bempedoic Acid/FDC With Ezetimibe
Measured: Baseline up to 12 months
Mean Treatment Duration, By Therapy
Measured: Baseline up to 12 months
Mean Dosage of Bempedoic Acid/FDC Treatment
Measured: Baseline up to 12 months
Mean Length of Prescription Intervals of Bempedoic Acid/FDC Treatment
Measured: Baseline up to 12 months
Number of Participants Who Permanently Discontinued or Switched From Bempedoic Acid/FDC Treatment
Measured: Baseline up to 12 months
Healthcare Resource Use In Participants Who Were Treated With Bempedoic Acid/FDC With Ezetimibe Treatment
Measured: Baseline up to 12 months
Mean Change From Baseline In EuroQol (EQ-5D-5L) and PAM-13
Measured: Baseline up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Why it stopped: Due to patient availability
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798390
- Sponsor's protocol ID
- DSE-BMP-01-22-EU
- Acronym
- MILOS-Spain
- Status last verified
- Nov 2023
- First submitted
- 10 Mar 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05798390
- Acronym / sponsor ID
- MILOS-Spain / DSE-BMP-01-22-EU
- Conditions
- Primary Hypercholesterolemia, Mixed Dyslipidemia
- Keywords
- Primary Hypercholesterolemia, Mixed Dyslipidemia, Bempedoic acid and/or its fixed-dose combination with ezetimibe
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to patient availability
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This non-interventional study will be conducted in order to further understand the potential risks and benefits of bempedoic acid/fixed dose combination (FDC) with ezetimibe in a real-world clinical setting in adult patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia and to gain insight into the effectiveness (managing plasma levels of LDL-C) as well as safety (clinical events associated with the treatment modalities). No study medication will be provided as part of this protocol to the patients. Medications will be as prescribed by the treating physician in line with clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bempedoic acid and/or fixed-dose combination with ezetimibe | – | Drug: Bempedoic acid and/or its fixed dose combination with ezetimibeParticipants with primary hypercholesterolemia or mixed dyslipidemia who received bempedoic acid and/or its fixed-dose combination with ezetimibe. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of 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 no reimbursement conditions (Part 1) or under reimbursed conditions (Part 2) at enrollment and who are unable to reach their LDL-C goals with the maximum tolerated dose of statins or patients who are determined by their treating physician to be statin intolerant.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bempedoic acid and/or its fixed dose combination with ezetimibeThis is a non-interventional study. No study medication will be provided as part of this protocol to the patients. Medications will be as prescribed by the treating physician in line with clinical practice. | Drug | Bempedoic acid and/or fixed-dose combination with ezetimibe |
Primary outcome
Summary of Patient Characteristics in Participants With Primary Hypercholesterolaemia or Mixed Dyslipidaemia Following Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe
Time frame: Baseline up to 12 months
17 secondary outcomes
Mean Change From Baseline in Systematic Coronary Risk Estimation (SCORE) System Following Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe
Time frame: Baseline up to 12 months
Mean Change From Baseline in Second Manifestations of Arterial Disease (SMART) Score Following Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe
Time frame: Baseline up to 12 months
Mean Change From Baseline in Framingham Risk Score Following Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe
Time frame: Baseline up to 12 months
Mean Change From Baseline in Low-density Lipoprotein Cholesterol Levels
Time frame: Baseline up to 12 months
Mean Change From Baseline in Atherosclerotic Cardiovascular Disease-Modifying Cholesterol Fragments Levels
Time frame: Baseline up to 12 months
Mean Change From Baseline in Inflammatory Marker hsCRP Levels
Time frame: Baseline up to 12 months
Mean Change From Baseline In Uric Acid Levels
Time frame: Baseline up to 12 months
Number of Participants With Relevant Cardiovascular (CV) Events
Time frame: Baseline up to 12 months
Number of Participants With Adverse Effects and Adverse Drug Reactions Associated With Bempedoic Acid/FDC Ezetimibe
Time frame: Baseline up to 12 months
Types of Practitioners Caring for Patients Treated With Bempedoic acid/ FDC with Ezetimibe
Time frame: Baseline up to 12 months
Number of Participants Who Reported Use of Lipid-modifying Treatments Prior To Or Concomitantly To Receiving Bempedoic Acid/FDC With Ezetimibe
Time frame: Baseline up to 12 months
Mean Treatment Duration, By Therapy
Time frame: Baseline up to 12 months
Mean Dosage of Bempedoic Acid/FDC Treatment
Time frame: Baseline up to 12 months
Mean Length of Prescription Intervals of Bempedoic Acid/FDC Treatment
Time frame: Baseline up to 12 months
Number of Participants Who Permanently Discontinued or Switched From Bempedoic Acid/FDC Treatment
Time frame: Baseline up to 12 months
Healthcare Resource Use In Participants Who Were Treated With Bempedoic Acid/FDC With Ezetimibe Treatment
Time frame: Baseline up to 12 months
Mean Change From Baseline In EuroQol (EQ-5D-5L) and PAM-13
Time frame: Baseline up to 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Leader study director
Daiichi Sankyo
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Hypercholesterolemia and Mixed Dyslipidemia, run by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summary of Patient Characteristics in Participants With Primary Hypercholesterolaemia or Mixed Dyslipidaemia Following Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe (time frame: Baseline up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.