Effect of Atorvastatin and Omega 3 Combination Therapy on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes and Combined Dyslipidemia

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
SNUBH
RECRUITING
Seongnam-si
Contact Information
Primary
Soo Lim
limsoo@snu.ac.kr
+82-31-787-7035
Backup
Minji Sohn
rainbowmjs@naver.com
Time Frame
Start Date: 2022-10-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 105
Treatments
Experimental: 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
Active_comparator: Atmeg
Atmeg: 2 capsules daily (1 capsule containes atorvastatin 10 mg and Omega-3 1000 mg)
Active_comparator: ezetimibe/atorvastatin 10/20
1 tablet once daily (atorvastatin 20mg with ezetimibe 10mg)
Related Therapeutic Areas
Sponsors
Collaborators: Korea United Pharm. Inc.
Leads: Seoul National University Bundang Hospital

This content was sourced from clinicaltrials.gov

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