Randomized Controlled Trial of Olmesartan Medoxomil Administration in the Prevention of Hepatic Fibrosis in the selected Patients with Cirrhosis

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003975

Enrollment

Registered

2010-08-01

Start date

2008-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis, Child A or B

Interventions

Olmesartan Medoxomil Control

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (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.

Exclusion criteria

Exclusion criteria: (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.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the rate of patients showing reduction in HVPG of more than 20% of baseline values after a year.	—

Secondary

Measure	Time frame
The secondary endpoint is the rate of patients showing reduction in blood markers of hepatic fibrosis	—

Countries

Japan

Contacts

Public ContactHisashi Hidaka

Kitasato University East Hospital Department of Gastroenterology, Internal Medicine

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026