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NCT02847624 Clinical Trial

Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD

Polycystic Kidney, Autosomal Dominant Clinical Trial

Official title:
Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD in Japan

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02847624
Other study ID # 15600-003
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 24, 2014
Est. completion date September 20, 2022

Study information
Verified date December 2023
Source Otsuka Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate the safety and effectiveness of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD) in the real world clinical setting in Japan.

Recruitment information / eligibility
Status Completed
Enrollment 1672
Est. completion date September 20, 2022
Est. primary completion date September 20, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - diagnosed ADPKD - total kidney volume of 750 or more Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• tolvaptan

Locations
Country Name City State
Japan Otsuka Pharmaceutical Co., Ltd. Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary total kidney volume 8 years
Secondary liver function 8 years
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