Atmeg (Atorvastatin and Omega-3 Combination) and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia
NCT ID: NCT05365438
Last Updated: 2024-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
105 participants
INTERVENTIONAL
2022-10-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Atmeg with Omethyl Cutielet
Atmeg: 2 capsules daily (1 capsule containes atorvastatin 10 mg and Omega-3 1000 mg) Omethyl Cutielet: Omega-3 2000mg (920mg as EPA ethyl ester, 760mg as DHA ethyl ester) once daily
Omega 3-Atorvastatin
Atmeg 2 capsules with 1 pack of Omethyl cutielet
Atmeg
Atmeg: 2 capsules daily (1 capsule containes atorvastatin 10 mg and Omega-3 1000 mg)
Omega 3-Atorvastatin
Atmeg 2 capsules
ezetimibe/atorvastatin 10/20
1 tablet once daily (atorvastatin 20mg with ezetimibe 10mg)
Atorvastatin-Ezetimibe
ezetimibe/atorvastatin 10/20 mg
Interventions
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Omega 3-Atorvastatin
Atmeg 2 capsules with 1 pack of Omethyl cutielet
Omega 3-Atorvastatin
Atmeg 2 capsules
Atorvastatin-Ezetimibe
ezetimibe/atorvastatin 10/20 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
80 Years
ALL
No
Sponsors
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Korea United Pharm. Inc.
INDUSTRY
Seoul National University Bundang Hospital
OTHER
Responsible Party
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Soo Lim
Professor
Locations
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SNUBH
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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B-2111-720-004
Identifier Type: -
Identifier Source: org_study_id
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