Long-term study of Ezefeno added to statin for high cholesterol and diabetes
Tests Ezefeno with a statin in adults with high cholesterol and type 2 diabetes.
Plain-language title generated from the registry record
Registry title: To Assess With Ezefeno Tab. in Patients With Dyslipidemia and T2DM
Key facts
- Where
- Seoul, South KoreaSee the site
Where in South Korea
- Korea University Anam HospitalSeoul, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Korea University Anam Hospital
- Trial code
- NCT06293417
- Record updated
- 27 August 2024
- Original description
The goal of this Randomized controlled trials is to assess in the long term efficacy and safety of ezefeno. The primary endpoint are:Read full original descriptionShow less
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
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
Inclusion: 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: Uncontrolled hyperglycemia(more than 12.0% for Subject treated with anti-diabetic treatment.); AST/ALT more than 3 ULN; Clinical evidence of genetic disorders such as galactose intolerance, Lapp lactose deficiency, and/or glucose-galactose malabsorption; Pregnant or breastfeeding women; Patient with myopathy and rhabdomyolysis.