A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]

PHASE3CompletedINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

November 30, 2010

Primary Completion Date

August 31, 2014

Study Completion Date

August 31, 2014

Conditions
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Interventions
DRUG

tolvaptan

Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg.

Trial Locations (7)

Unknown

Chubu Region

Chugoku Region

Hokkaido Region

Kanto Region

Kinki Region

Kyushu Region

Tohoku Region

All Listed Sponsors
lead

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

NCT01280721 - A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan] | Biotech Hunter | Biotech Hunter