Actively Recruiting

Phase Not Applicable
Age: 19Years +
All Genders
NCT06293417

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

Led by Korea University Anam Hospital · Updated on 2024-08-27

3958

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with type 2 diabetes diagnosed by American Diabetes Association criteria
  • Age 19 years or older
  • Non-HDL-C at least 100 mg/dL and triglycerides between 200 and 500 mg/dL while on moderate-intensity statins
  • Presence of cardiovascular risk factors
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Uncontrolled hyperglycemia with HbA1c over 12.0% despite anti-diabetic treatment
  • History of myopathy or rhabdomyolysis
  • Liver enzymes (AST/ALT) more than 3 times the upper limit of normal
  • Clinical evidence of genetic disorders such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Korea University Anam Hospital

Seoul, South Korea

Actively Recruiting

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Research Team

S

SIN-GON KIM

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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