Actively Recruiting
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
Led by Korea University Anam Hospital · Updated on 2024-08-27
3958
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term efficacy and safety of a combined therapy using Ezefeno tablets in patients who have dyslipidemia and type 2 diabetes mellitus (T2DM). The study focuses on patients who do not achieve adequate control of non-HDL cholesterol levels despite moderate-intensity statin treatment. This randomized, open-label, multicenter trial aims to assess major adverse cardiovascular events and diabetic microvascular events over 48 months. Participants will be randomly assigned to one of two groups: a treatment group receiving a combination of ezetimibe/fenofibrate (Ezefeno) with moderate-intensity statins, or a control group undergoing dose escalation of moderate-intensity statins alone. The trial will last for 48 months, during which the effects of these treatment strategies on cholesterol levels and cardiovascular outcomes will be monitored. During the study, participants will undergo regular assessments to measure major cardiovascular and microvascular events. Researchers will also track changes in lipid profiles, including non-HDL cholesterol, LDL, HDL-C, triglycerides, and cholesterol ratios. Safety and adherence will be monitored throughout the trial duration. The study spans from baseline through 48 months, with ongoing monitoring to evaluate both efficacy and safety outcomes.
CONDITIONS
Brief Title
To Assess With Ezefeno Tab. in Patients With Dyslipidemia and T2DM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with type 2 diabetes diagnosed by American Diabetes Association criteria
- Age 2 19 years
- Non-HDL-C 2 100 mg/dL and triglycerides between 200 and 500 mg/dL while on moderate-intensity statins
- Presence of cardiovascular risk factors
You will not qualify if you...
- Pregnant or breastfeeding women
- Uncontrolled hyperglycemia with HbA1c over 12.0% despite anti-diabetic treatment
- History of myopathy or rhabdomyolysis
- Elevated liver enzymes (AST/ALT more than 3 times the upper limit of normal)
- Genetic disorders such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 48 months from baseline
Participants receive either combined therapy with Ezefeno Tab. and moderate-intensity statin or dose escalation of moderate-intensity statin to manage dyslipidemia and type 2 diabetes.
Trial Site Locations
Total: 1 location
1
Korea University Anam Hospital
Seoul, South Korea
Actively Recruiting
Research Team
S
SIN-GON KIM
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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