NCT06293417Recruiting
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
Source: ClinicalTrials.gov · Last updated 27 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 3958 (estimated)
- First submitted
- 19 Feb 2024
- Start date
- 1 Mar 2024
- Primary completion date
- 1 Feb 2027
- Lead sponsor
- Korea University Anam Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT06293417
What you commit to
- Study type: Interventional
- Planned participants: 3958
- From 1 Mar 2024 to the primary completion date, 1 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Uncontrolled hyperglycemia(more than 12.0% for Subject treated with anti-diabetic treatment.)
Lab values
- AST/ALT more than 3 ULN
- Clinical evidence of genetic disorders such as galactose intolerance, Lapp lactose deficiency, and/or glucose-galactose malabsorption
Other
- Pregnant or breastfeeding women
- Patient with myopathy and rhabdomyolysis
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
Related publications
- Study Design and Protocol for a Randomized Controlled Trial to Assess Long-Term Efficacy and Safety of a Triple Combination of Ezetimibe, Fenofibrate, and Moderate-Intensity Statin in Patients with Type 2 Diabetes and Modifiable Cardiovascular Risk Factors (ENSEMBLE).Endocrinol Metab (Seoul) · 2024 · PMID 39174014
This page is information, not medical advice. Discuss any trial with your doctor.