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Recruiting NCT06293417

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

No phase Interventional T2DM (Type 2 Diabetes Mellitus) Dyslipidemias

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin, Dose escalation of moderate-intensity statin.
Who it may be relevant to
Registry conditions: T2DM (Type 2 Diabetes Mellitus), Dyslipidemias. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

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.

Interventions

  • Drug Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin
    Treatment group
  • Drug Dose escalation of moderate-intensity statin
    Control group

Primary outcome measures

  • major adverse cardiovascular events and diabetic microvascular events for 48 months [Time frame: 48month from baseline]
Secondary outcome measures (8)
  • proportion of patients achieving Non-HDL-C less than 100mg/dL [Time frame: 48month from baseline]
  • proportion of patients achieving LDL less than 70mg/dL [Time frame: 48month from baseline]
  • change in Non-HDL-C at 48month from baseline [Time frame: 48month from baseline]
  • change in LDL at 48month from baseline [Time frame: 48month from baseline]
  • change in HDL-C at 48month from baseline [Time frame: 48month from baseline]
  • change in TG at 48month from baseline [Time frame: 48month from baseline]
  • change in LDL-C/HDL-C ratio at 48month from baseline [Time frame: 48month from baseline]
  • change in TC/HDL-C ratio at 48month from baseline [Time frame: 48month from baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Korea University Anam Hospital — Seoul

Publications

  • Kim NH, Lee J, Chon S, Yu JM, Jeong IK, Lim S, Kim WJ, Song K, Cho HC, Yu HM, Kim KA, Kim SS, Lee SH, Kim CH, Kwak SH, Lee YH, Chung CH, Lee S, Jin HY, Lee JH, Koh G, Kim SY, Kim J, Lee JH, Kim TN, Jeon HJ, Lee JH, Jeon JH, Yoo HJ, Kim HK, Park HK, Nam-Goong IS, Hong S, Ahn CW, Yu JH, Park JH, Park KG, Park CH, Joung KH, Ryu OH, Park KY, Hong EG, Cha BS, Won KC, Chung YS, Kim SG. Study Design and PMID 39174014

Identifiers

NCT: NCT06293417 · HT-EF-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗