Unique ID issued by UMIN | UMIN000025175 |
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Receipt number | R000028928 |
Scientific Title | Compared effects of ezetimibe and omega-3-acid ethyl esters on lipid metabolism in type 2 diabetic patients with hypercholesterolemia |
Date of disclosure of the study information | 2016/12/07 |
Last modified on | 2018/12/31 11:34:08 |
Compared effects of ezetimibe and omega-3-acid ethyl esters on lipid metabolism in type 2 diabetic patients with hypercholesterolemia
Ezetimibe and omega-3-acid ethyl esters study
Compared effects of ezetimibe and omega-3-acid ethyl esters on lipid metabolism in type 2 diabetic patients with hypercholesterolemia
Ezetimibe and omega-3-acid ethyl esters study
Japan |
High-risk Hypercholesterolemia
Medicine in general | Endocrinology and Metabolism |
Others
NO
To compare the effect of ezetimibe and omega-3-acid ethyl esters on lipid metabolism, glucometabolism, renal function, endothelial function and inflammation markers in high-risk patients with type 2 diabetic hypercholesterolemia
Efficacy
Confirmatory
Pragmatic
Phase IV
Change of non HDL-Cholesterol between two arms at week 12.
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.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Current statin + Ezetimibe 10 mg/day
Current strong statin + omega-3 acid ethyl esters 2 g/day
20 | years-old | < |
Not applicable |
Male and Female
1. LDL-C>=120mg\ or nonHDL-C>=150mg/dL
2. Type 2 diabetes mellitus
3. Using statin
4. Adult (Age>=20years old)
5. No alternation of lipid lowering/oral diabetic agents within 12 weeks.
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
70
1st name | |
Middle name | |
Last name | Sho-ichi Yamagishi |
Kurume University School of Medicine
Department of Pathophysiology and Therapeutics of Diabetic Vascular Complications
Asahimachi 67, Kurume, Fukuoka
0942-35-3311
shoichi@med.kurume-u.ac.jp
1st name | |
Middle name | |
Last name | Yosuke Nakayama |
Kurume University School of Medicine
Division of Nephrology, Department of Medicine, Kurume University School of Medicine
Asahimachi 67, Kurume, Fukuoka
0942-35-3311
nakayama_yosuke@med.kurume-u.ac.jp
Kurume University School of Medicine
Bayer Yakuhin Ltd.
Profit organization
NO
久留米大学病院(福岡県)
益子医院(福岡県)
永江内科(福岡県)
松尾医院(福岡県)
星子医院(福岡県)
よしやま内科(福岡県)
植田医院(福岡県)
田中内科(福岡県)
二宮医院(福岡県)
津末医院(福岡県)
峯﨑胃腸科内科(福岡県)
2016 | Year | 12 | Month | 07 | Day |
Unpublished
Completed
2015 | Year | 03 | Month | 06 | Day |
2015 | Year | 03 | Month | 06 | Day |
2019 | Year | 03 | Month | 31 | Day |
2016 | Year | 12 | Month | 07 | Day |
2018 | Year | 12 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028928
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