Unique ID issued by UMIN | UMIN000003975 |
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Receipt number | R000004717 |
Scientific Title | Randomized Controlled Trial of Olmesartan Medoxomil Administration in the Prevention of Hepatic Fibrosis in the selected Patients with Cirrhosis |
Date of disclosure of the study information | 2010/08/01 |
Last modified on | 2010/07/17 22:28:58 |
Randomized Controlled Trial of Olmesartan Medoxomil Administration in the Prevention of Hepatic Fibrosis in the selected Patients with Cirrhosis
Efficacy of Olmesartan in the Prevention of Hepatic Fibrosis
Randomized Controlled Trial of Olmesartan Medoxomil Administration in the Prevention of Hepatic Fibrosis in the selected Patients with Cirrhosis
Efficacy of Olmesartan in the Prevention of Hepatic Fibrosis
Japan |
Liver Cirrhosis, Child A or B
Hepato-biliary-pancreatic medicine |
Others
NO
The aim of this study is to evaluate the long-term effects of olmesartan, an angiotensin type 1 (AT1) receptor blocker, on hemodynamic and on liver fibrosis.
Safety
Confirmatory
Phase II
The primary endpoint is the rate of patients showing reduction in HVPG of more than 20% of baseline values after a year.
The secondary endpoint is the rate of patients showing reduction in blood markers of hepatic fibrosis
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
No treatment
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Medicine |
Olmesartan Medoxomil
Control
20 | years-old | <= |
75 | years-old | >= |
Male and Female
(1) age between 18 and 75 years; (2) proven liver cirrhosis with a diagnosis based on histology or unequivocal clinical, sonographic, and laboratory findings; (3) alcoholic etiology of cirrhosis had to have refused taking alcohol for >=3 months before the start of the study; (4) Child-Pugh score >=9; and (5) absent or small esophageal varices.
(1) mean arterial pressure <60 mmHg; (2) ARB intolerance; (3) current treatment with ARB, angiotensin-converting enzyme inhibitors, or beta-blockers; (4) hypertrophic cardiomyopathy or renal arterial stenosis; (5) serum creatinine >1.6 mg/dL; (6) hyperkalemia defined as plasma potassium >5.5 meq/L; (7) hepatocellular carcinoma; and (8) portal thrombosis. Current treatment with diuretics was allowed and not changed during the study period.
44
1st name | |
Middle name | |
Last name | Hisashi Hidaka |
Kitasato University East Hospital
Department of Gastroenterology, Internal Medicine
2-1-1 Asamizodai, Minami-ku, Sagamihara, Kanagawa
042-748-9111
1st name | |
Middle name | |
Last name | Hisashi Hidaka |
Kitasato University East Hospital
Department of Gastroenterology, Internal Medicine
2-1-1 Asamizodai, Minami-ku, Sagamihara, Kanagawa
Kitasato University
Kitasato University
Self funding
NO
北里大学東病院
2010 | Year | 08 | Month | 01 | Day |
Unpublished
Completed
2007 | Year | 12 | Month | 01 | Day |
2008 | Year | 01 | Month | 01 | Day |
2010 | Year | 06 | Month | 01 | Day |
2010 | Year | 08 | Month | 01 | Day |
2010 | Year | 07 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004717
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