Compared effects of ezetimibe and omega-3-acid ethyl esters on lipid metabolism in type 2 diabetic patients with hypercholesterolemia

Phase 4

• Conditions: High-risk Hypercholesterolemia

• Registration Number: JPRN-UMIN000025175
• Lead Sponsor: Kurume University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-07
• Study Completion: 2019-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

1.Currently treated with EPA or study drugs 2.Treated with insulin 3.Hypersensitivity with study drugs 4.Severe liver dysfunction (AST or ALT >=100 IU) 5.History of cerebro/cardiovascular disease 6.Secondary hyperlipidemia 7.Pregnant, brestfeeding or risk of pregnant woman 8.Familial hypercholesterolemia 9.Patients inappropriate for the trial judged by investigators

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of non HDL-Cholesterol between two arms at week 12.

Secondary Outcome Measures

Name	Time	Method
Change in all measurments (TC, HLD-C, LDL-C, RLP-C, sLDL-C, MDA-LDL, TG, ApoB-48, ApoB-100, Campesterol, Sitosterol, Lathosterol, AGEs, FBS, HOMA-IR, BUN, Creatinin, Urinary albumin, Urinary creatinin, hsCRP, Adiponectin, ICAM-1, VCAM-1, RAGE, ADMA) at week 12.