Unique ID issued by UMIN | UMIN000002011 |
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Receipt number | R000002449 |
Scientific Title | Efficacy and safety of statin treatment for hypercholesterolemia with chronic liver disease |
Date of disclosure of the study information | 2009/05/27 |
Last modified on | 2012/11/29 22:53:40 |
Efficacy and safety of statin treatment for hypercholesterolemia with chronic liver disease
Efficacy and safety of statin treatment for hypercholesterolemia with chronic liver disease
Efficacy and safety of statin treatment for hypercholesterolemia with chronic liver disease
Efficacy and safety of statin treatment for hypercholesterolemia with chronic liver disease
Japan |
chronic liver disease
Hepato-biliary-pancreatic medicine |
Others
NO
To examine the efficacy and safety of the long-term treatment of pitavastatin for hypercholesterolemia with chronic liver disease through blood examination and diagnostic imaging.
Safety,Efficacy
Exploratory
1.Change in AST, ALT, gammaGTP, ALP(for NAFLD, NASH)
2.Change in HCV RNA(for hepatitis C)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Pitavastatin 1-2mg/day
20 | years-old | <= |
75 | years-old | > |
Male and Female
(1)Hypercholesterolemia
(2)Chronic liver disease(NAFLD/NASH, hepatitis C)
(3)Age 20 to 74
(4)Patients who received sufficient explanation and agreed with written informed consent
(1)Contraindication or relative contraindication of pitavastatin calcium.
-Hypersensitivity for pitavastatin calcium
-Serious hepatic disorder or biliary atresia
-Receiving ciclosporin
-Pregnant women, women suspected of being pregnant, or lactating women
-Patients receiving fibrates who have abnormal laboratory test values about renal function
(2)Women hoping to become pregnant during the study
(3)Drug abuse, alcoholism
(4)Patients judged to be inappropriate by the attending doctor
50
1st name | |
Middle name | |
Last name | Toshifumi Ohkusa |
The Jikei University School of Medicine, Kashiwa Hospital
Division of Gastroenterology and Hepatology
163-1 kashiwashita, Kashiwa, Chiba 277-8567, Japan
1st name | |
Middle name | |
Last name | Toshifumi Ohkusa |
The Jikei University School of Medicine, Kashiwa Hospital
Division of Gastroenterology and Hepatology
163-1 kashiwashita, Kashiwa, Chiba 277-8567, Japan
04-7164-1111
ohkusa@jikei.ac.jp
The Jikei University School of Medicine, Kashiwa Hospital
The Jikei University School of Medicine, Kashiwa Hospital
Self funding
NO
2009 | Year | 05 | Month | 27 | Day |
Unpublished
The cases did not meet only 10 patients, the study was discontinued.
Terminated
2009 | Year | 05 | Month | 13 | Day |
2009 | Year | 06 | Month | 01 | Day |
2011 | Year | 05 | Month | 01 | Day |
2012 | Year | 11 | Month | 29 | Day |
2009 | Year | 05 | Month | 26 | Day |
2012 | Year | 11 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002449
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