To Assess With Ezefeno Tab. in Patients With Dyslipidemia and T2DM
NCT ID: NCT06293417
Last Updated: 2024-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
3958 participants
INTERVENTIONAL
2024-03-01
2027-02-01
Brief Summary
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* major adverse cardiovascular events within 48 months of the trial duration
* microvascular events within 48 months of the trial duration
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment group
Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin
Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin
Treatment group
Control group
Dose escalation of moderate-intensity statin
Dose escalation of moderate-intensity statin
Control group
Interventions
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Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin
Treatment group
Dose escalation of moderate-intensity statin
Control group
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 19 years
* Non-HDL-C ≥100 mg/dL, TG ≥200, \<500 mg/dL on moderate-intensity statins
* with cardiovascular risk factor
Exclusion Criteria
* Uncontrolled hyperglycemia(more than 12.0% for Subject treated with anti-diabetic treatment.)
* Patient with myopathy and rhabdomyolysis
* AST/ALT more than 3 ULN
* Clinical evidence of genetic disorders such as galactose intolerance, Lapp lactose deficiency, and/or glucose-galactose malabsorption
19 Years
ALL
No
Sponsors
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Korea University Anam Hospital
OTHER
Responsible Party
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Sin Gon Kim
professor
Principal Investigators
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SIN-GON KIM
Role: PRINCIPAL_INVESTIGATOR
Korea University Anam Hospital
Locations
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Korea University Anam Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Sin Gon Kim, MD
Role: primary
Other Identifiers
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HT-EF-01
Identifier Type: -
Identifier Source: org_study_id
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