NCT05365438 Atmeg (Atorvastatin and Omega-3 Combination) and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia
| NCT ID | NCT05365438 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Seoul National University Bundang Hospital |
| Condition | Dyslipidemias |
| Study Type | INTERVENTIONAL |
| Enrollment | 105 participants |
| Start Date | 2022-10-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 105 participants in total. It began in 2022-10-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a randomized controlled study to assess the effect of atorvastatin and omega 3 combination therapy compared with atorvastatin and ezetimibe combination therapy in Korean T2DM patients with asymptomatic atherosclerosis.
Eligibility Criteria
Inclusion Criteria: * Type 2 diabetes under treatment with HbA1c 6.0-10.0% at screening visit * Male or female of 20 years or over * Mixed dyslipidemia under moderate-intensity statin: triglyceride ≥200 mg/dL, HDL-cholesterol ≤50 mg/dL, LDL-cholesterol ≥100 mg/dL * moderate-intensity statin: atorvastatin 10-20mg, rosuvastatin 5mg, simvastatin 20-40mg, pravastatin 40-80mg, lovastatin 40mg, fluvastatin XL 80mg, fluvastatin 40mg bid, pitavastatin 2-4mg * Identified carotid artery plaque: carotid intima-media thickness (cIMT) ≥ 1.0 mm * Asymptomatic patients without history of angina, myocardial infarction, or cerebral infarction * Creatinine ≤1.8 mg/dL Exclusion Criteria: * Dyslipidemia which requires other therapy: triglyceride ≥500 mg/dL or LDL-cholesterol ≥190 mg/dL * Uncontrolled hypertension: SBP \>180 mmHg or DBP \>110 mmHg * Severe renal dysfunction: eGFR \<30 mL/min/1.73m2 * AST/ALT \>120/120 or chronic liver disease * Pregnant or childbearing woman who does not have enough contraception * Changes of medication related to chronic diseases (diabetes, hypertension, dyslipidemia, etc.) within 3 months * Usage of dyslipidemia therapy other than statin
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05365438 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 80 Years, studying Dyslipidemias. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05365438 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05365438 currently recruiting?
Yes, NCT05365438 is actively recruiting participants. Contact the research team at limsoo@snu.ac.kr for enrollment information.
Where is the NCT05365438 trial being conducted?
This trial is being conducted at Seongnam-si, South Korea.
Who is sponsoring the NCT05365438 clinical trial?
NCT05365438 is sponsored by Seoul National University Bundang Hospital. The trial plans to enroll 105 participants.