To Assess With Ezefeno Tab. in Patients With Dyslipidemia and T2DM
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
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
Treatments tested in this trial
- Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin
- Dose escalation of moderate-intensity statin
Treatment groups
3,958 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov