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]

A Multicenter, Open-label Extension 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]

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 23 Years – 53 Years
• Healthy volunteers: Not accepted

Summary

ADPKD patients who enrolled in Trial 156-04-251 will receive repeated oral administration of tolvaptan twice daily (morning and evening: 45mg/15mg, 60mg/30mg, or 90mg/30mg).

Conditions

• Autosomal Dominant Polycystic Kidney Disease （ADPKD)

Interventions

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

Timeline

• Start date: 2010-11-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2011-01-21
• Last updated: 2019-01-17
• Results posted: 2019-01-17

Locations

7 sites across 1 country: Japan