Unique ID issued by UMIN | UMIN000008075 |
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Receipt number | R000009495 |
Scientific Title | Efficacy of rosuvastatin for the treatment of Non-alcoholic fatty liver disease with hyperlipidemia |
Date of disclosure of the study information | 2012/06/01 |
Last modified on | 2016/12/05 09:40:57 |
Efficacy of rosuvastatin for the treatment of Non-alcoholic fatty liver disease with hyperlipidemia
effect of rosvastatin in patients with NAFLD
Efficacy of rosuvastatin for the treatment of Non-alcoholic fatty liver disease with hyperlipidemia
effect of rosvastatin in patients with NAFLD
Japan |
Non-alcoholic fatty liver disease with hypercholesterolemia
Hepato-biliary-pancreatic medicine |
Others
NO
To investigate the effect of rosuvastatin on liver transaminase and lipid profile in Non-alcoholic fatty liver disease patients with hypercholesterolemia
Efficacy
Confirmatory
Pragmatic
Not applicable
Percent change of liver transaminases composition in 6 months
1) Percent change of lipid profile in 6 months
2) Low-density lipoprotein cholesterol goal achievement ratio recommended by the Japan Atherosclerosis Society(JAS) in 6 months
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
rosvastatin 5mg/day
20 | years-old | <= |
80 | years-old | > |
Male and Female
1) Diagnosed as fatty liver by abdominal ultrasonography within 6 months before it registers
2) Patients with hyperlipidemia
(Patient who are not treated:LDL-C level of more than 140 mg/dl)
3) No limitations on gender or hospitalization status
4) Patients giving written consent after being provided with sufficient explanation about participation in this clinical trial
1) Patients with hypersensitivity to HMG-CoA reductase inhibitor (statin)
2) Uncontrolled diabetes
3) Viral or autoimmune liver disease
4) Patients with severe liver dysfunction(ALT or AST > 100 IU/L or total bilirubin > 2.5 mg/dL or ALB < 3.5g/dl or PT < 70% or PLT < 100,000/ul)
5) Patients with renal dysfunction (the serum creatinine more than 2.0 mg/dL or Ccr<30mL/min/1.73mm)
6) Patients on treatment with cyclosporine
7) Pregnant and potential pregnancy
8) Patients with hypothyroidism, hereditary myopathy (muscular dystrophy) or family history of hereditary myopathy, and drug-induced myopathy
9) Patients with drug abuse or alcoholism
10) Patients who are ineligible for any other reason in the opinion of the investigator
25
1st name | |
Middle name | |
Last name | Kenichi Ikejima |
Juntendo University School of Medicine
Department of Gastroenterology
2-1-1, Hongo, Bunkyo-ku, Tokyo
81338133111
ikejima@juntendo.ac.jp
1st name | |
Middle name | |
Last name | Kyoko Fukuhara |
Juntendo University School of Medicine
Department of Gastroenterology
2-1-1, Hongo, Bunkyo-ku, Tokyo
81338133111
kyokof@juntendo.ac.jp
Juntendo University School of Medicine
none
Self funding
NO
順天堂大学医学部附属順天堂医院
2012 | Year | 06 | Month | 01 | Day |
Unpublished
Open public recruiting
2012 | Year | 06 | Month | 01 | Day |
2012 | Year | 06 | Month | 01 | Day |
2012 | Year | 06 | Month | 01 | Day |
2016 | Year | 12 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009495
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