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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Republic of Korea
Korea University Anam Hospital
RECRUITING
Seoul
Contact Information
Primary
SIN-GON KIM
k50367@korea.ac.kr
8229205890
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2027-02-01
Participants
Target number of participants: 3958
Treatments
Experimental: Treatment group
Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin
Active_comparator: Control group
Dose escalation of moderate-intensity statin
Related Therapeutic Areas
Sponsors
Leads: Korea University Anam Hospital