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Clinical Trials in South Korea / NCT06293417
Recruiting Not applicable

To Assess With Ezefeno Tab. in Patients With Dyslipidemia and T2DM

NCT06293417 · tracked via the Priya Life Science South Korea tracker
Sponsor
Korea University Anam Hospital
Phase
Not applicable
Started
2024-03-01
Last updated
2024-08-27

Condition(s) studied

T2DM (Type 2 Diabetes Mellitus)Dyslipidemias

Investigational drug(s) / intervention(s)

Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statinDose escalation of moderate-intensity statin

Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin: Treatment group

Dose escalation of moderate-intensity statin: Control group

Study summary

The goal of this Randomized controlled trials is to assess in the long term efficacy and safety of ezefeno. The primary endpoint are:

* major adverse cardiovascular events within 48 months of the trial duration
* microvascular events within 48 months of the trial duration

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients with type 2 diabetes diagnosed by American Diabetes Association 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: * Pregnant or breastfeeding women * 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

Primary outcome measure(s)

  • major adverse cardiovascular events and diabetic microvascular events for 48 months — 48month from baseline
    major adverse cardiovascular events and diabetic microvascular events for 48 months

Trial sites (1)

FacilityCityRegionStatus
Korea University Anam Hospital Seoul South Korea Recruiting

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Other trials for the same condition

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Clinical Comparison of Low-dose Rosuvastatin Plus Ezetimibe Combination Therapy and High-dose Rosuvastatin Monotherapy in Patients With Minimal to Intermediate Coronary Artery Disease Without Percutaneous Coronary Intervention Recruiting
Exploring Approaches With Lower Targets of Blood Pressure and Lipid for Improving Renal Outcome in Advanced Chronic Kidney Disease Recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06293417 on ClinicalTrials.gov ↗ ← All trials in South Korea