Status:
COMPLETED
A Study to Investigate the Effectiveness and Safety of Bempedoic Acid in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia in Taiwan
Lead Sponsor:
Daiichi Sankyo
Conditions:
Primary Hypercholesterolemia or Mixed Hyperlipidemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Cardiovascular disease (CVD) is a chronic non-communicable disease among the most common causes of death worldwide. Substantial reductions in risks of CVD can be achieved through the management of mod...
Detailed Description
This is a multicenter, prospective, phase IV, single-arm, interventional study investigating the effectiveness and safety of bempeodoic acid in Taiwanese patients with hypercholesterolemia or mixed dy...
Eligibility Criteria
Inclusion
- At least 18 years of age
- Diagnosed with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia:
- Patients who have been on statin or statin combining with other lipid-lowering therapies\* (both under the maximum tolerated dose of statin) for at least 4 weeks, but unable to reach LDL-C goals† OR
- Patients who are statin-intolerant or contraindicated to statin, alone or have been on other non-statin lipid-lowering therapies\* for at least 4 weeks, but unable to reach LDL-C goals†
- \* Other lipid-lowering therapies: Ezetimibe, Cholesterol and/or bile acid, absorption inhibitors, PCSK9 inhibitors, Omega-3 fatty acids, Fibrates, or Niacin derivatives
- † LDL-C goals are defined as:
- Patients with ASCVD or had conducted coronary revascularization procedures (e.g., PCI or CABG): LDL-C \< 70 mg/dL
- Patients aside from the above population: LDL-C \< 100 mg/dL
- The physician intends to prescribe bempedoic acid per locally approved label (the study intends no intervention in physicians' judgement on the prescription of bempedoic acid)
- Provide written informed consent
Exclusion
- Concurrent participation in an interventional study (simultaneous participation in other non-interventional studies is acceptable)
- With eGFR \< 30 mL/min/1.73 m2, end-stage renal disease (ESRD) on dialysis, severe hepatic impairment (Child-Pugh C), bempedoic acid contraindications (i.e., hypersensitivity to the active substance or any of the excipients, galactose intolerance, pregnancy, breastfeeding, concomitant use with simvastatin \> 40 mg daily)
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06925100
Start Date
April 1 2025
End Date
October 15 2025
Last Update
December 8 2025
Active Locations (3)
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1
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 807
2
Far Eastern Memorial Hospital
New Taipei City, Taiwan, 220
3
Linkou Chang Gung Memorial Hospital
Taoyuan District, Taiwan, 333