Health TrialsbyHealthPanel

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

ConditionsT2DM (Type 2 Diabetes Mellitus)Dyslipidemias
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorKorea University Anam Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin

    Drug

    Treatment group

  • Dose escalation of moderate-intensity statin

    Drug

    Control group

Treatment groups

3,958 Participants
are divided into 2 treatment groups
Group A: Treatment groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

major adverse cardiovascular events and diabetic microvascular events for 48 months

major adverse cardiovascular events and diabetic microvascular events for 48 months

Time frame
48month from baseline

Secondary outcomes

1

proportion of patients achieving Non-HDL-C less than 100mg/dL

proportion of patients achieving Non-HDL-C less than 100mg/dL

Time frame
48month from baseline
2

proportion of patients achieving LDL less than 70mg/dL

proportion of patients achieving LDL less than 70mg/dL

Time frame
48month from baseline
3

change in Non-HDL-C at 48month from baseline

change in Non-HDL-C at 48month from baseline

Time frame
48month from baseline
4

change in LDL at 48month from baseline

change in LDL at 48month from baseline

Time frame
48month from baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Korea University Anam Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now