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RECRUITINGNANCT06293417

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

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 tri...

Lead sponsor: Korea University Anam Hospital•1 locations•View source on ClinicalTrials.gov

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Contacts

SIN-GON KIM

CONTACT

8229205890 k50367@korea.ac.kr

Sponsors

Lead Sponsor

Korea University Anam Hospital

A prospective, randomized, open-label, parallel, multicenter, active-drug-controlled clinical trial to assess the long-term efficacy and safety of Combined Therapy with Ezefeno Tab. in patients with dyslipidemia who do not achieve adequate control of Non-HDL-C levels even with Moderate-intensity monotherapy.

Age

19 - No limit years

Sex

ALL

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: August 27, 2024Terms

Trial snapshot

StatusRECRUITING

PhaseNA

Enrollment3,958

Start dateMar 2024

Last updatedAug 27, 2024

Condition

T2DM (Type 2 Diabetes Mellitus)Dyslipidemias

Locations shown

Korea University Anam Hospital

Seoul

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 27, 2024Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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