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]

Phase 3 Completed 135 enrolled Otsuka Pharmaceutical Co., Ltd.

NaSingle-groupOpen-labelTreatment

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).

Timeline

Start: 2010-11
Primary completion: 2014-08
Completion: 2014-08

Publications

Muto S, Okada T, Yasuda M, Tsubouchi H, Nakajima K, Horie S. Long-term safety profile of tolvaptan in autosomal dominant polycystic kidney disease patients: TEMPO Extension Japan Trial. Drug Healthc Patient Saf. 2017 Oct 25;9:93-104. doi: 10.2147/DHPS.S142825. eCollection 2017.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tolvaptan	Small molecule	15 mg	Oral
Subject	Tolvaptan	Small molecule	30 mg	Oral
Subject	Tolvaptan	Small molecule	45 mg	Oral
Subject	Tolvaptan	Small molecule	60 mg	Oral
Subject	Tolvaptan	Small molecule	90 mg	Oral

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]

Summary

Timeline

Publications

Drugs

Indications