Analysis on individual difference in pharmacokinetics of tolvaptan and its metabolites, and investigation on predictive parameters of tolvaptan response and adverse effects in Japanese patiens

Analysis on individual difference in pharmacokinetics of tolvaptan and its metabolites, and investigation on predictive parameters of tolvaptan response and adverse effects in Japanese patiens - Analysis on individual difference in pharmacokinetics of tolvaptan and its metabolites, and investigation on predictive parameters of tolvaptan response and adverse effects in Japanese patiens

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000033065

Enrollment

200

Registered

2018-06-21

Start date

2017-06-08

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

heart failures, cirrhosis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients treated with tolvaptan for heart failures or cirrhosis 2. Patients receiving written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients discontinuing tolvaptan 2. Patients who are judged by physicians as inappropriate for study enrollment

Design outcomes

Primary

Measure	Time frame
Plasma concentrations of tolvaptan and its metabolites just before dosing on the 7th day after starting medication or later.	—

Countries

Japan

Contacts

Public ContactTakafumi Naito

Hamamatsu University School of Medicine Department of Hospital pharmacy

pharmacyham-adm@umin.ac.jp053-435-2763

Outcome results