NCT06293417

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,958 (estimated)
• Sponsor: Korea University Anam Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• T2DM (Type 2 Diabetes Mellitus)
• Dyslipidemias

Interventions

Type	Name	Description
DRUG	Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin	Treatment group
DRUG	Dose escalation of moderate-intensity statin	Control group

Timeline

• Start date: 2024-03-01
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2024-03-05
• Last updated: 2024-08-27

Locations

1 site across 1 country: South Korea