NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	High-risk Hypercholesterolemia
Date of first enrollment	2015/03/06
Target sample size	70
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Current statin + Ezetimibe 10 mg/day Current strong statin + omega-3 acid ethyl esters 2 g/day

Outcome(s)

Primary Outcome	Change of non HDL-Cholesterol between two arms at week 12.
Secondary Outcome	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.

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	Not applicable
Gender	Male and Female
Include criteria
Exclude 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