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To Assess With Ezefeno Tab. in Patients With Dyslipidemia and T2DM (ENSEMBLE)

K

Korea University

Status

Enrolling

Conditions

Dyslipidemias
T2DM (Type 2 Diabetes Mellitus)

Treatments

Drug: Dose escalation of moderate-intensity statin
Drug: Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin

Study type

Interventional

Funder types

Other

Identifiers

NCT06293417
HT-EF-01

Details and patient eligibility

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

Full 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.

Enrollment

3,958 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

3,958 participants in 2 patient groups

Treatment group
Experimental group
Description:
Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin
Treatment:
Drug: Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin
Control group
Active Comparator group
Description:
Dose escalation of moderate-intensity statin
Treatment:
Drug: Dose escalation of moderate-intensity statin

Trial contacts and locations

1

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Central trial contact

SIN-GON KIM

Data sourced from clinicaltrials.gov

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