Pharmacokinetics of Tolvaptan:Influence of portal hypertension

Pharmacokinetics of Tolvaptan:Influence of portal hypertension - Pharmacokinetics of Tolvaptan:Influence of portal hypertension

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000017284

Enrollment

Registered

2015-04-26

Start date

2015-04-26

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

Decompensated cirrhosis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with ascites due to cirrhosis, poorly reacted by following conventional diuretics. 1)more than 40mg furosemide + more than 25mg spironolactone or 2)more than 20mg furosemide + more than 50mg spironolactone

Exclusion criteria

Exclusion criteria: (1)Hepatic encephalopathy (2)Hepatocellular carcinoma vascular invasion is observed in hepatic vein trunk, portal vein trunk,or inferior vena cava (3)NYHA Class 3 or more of heart disease (4)anuria, urinary tract stenosis, stones, or tumors urinary excretion. (5)Patients with cerebrovascular disease within 30 days. (6)Patients with following laboratory values can be seen:Hb<8.0g/dl,T-bil> 4.0mg/dl,Cre>2.0mg/dl,serum Na>147mEq/l,serum K>5.5mEq/l

Design outcomes

Primary

Measure	Time frame
the relationship between the pharmacokinetics of Tolvaptan and portal hypertension.	—

Secondary

Measure	Time frame
the relationship between the diuretic effect and the pharmacokinetics of Tolvaptan.	—

Countries

Japan

Contacts

Public ContactEri Sagawa

Juntendo University Nerima Hospital Department of Gastroenterology

earai@juntendo.ac.jp03-5923-3111

Outcome results