drugset / Trial / NCT01022424

A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]

NCT01022424

Phase 3 Completed 13 enrolled Otsuka Pharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

ADPKD patients who were enrolled in Study 156-05-002 will receive repeated oral administration of OPC-41061 at doses of 15 mg twice daily (morning and evening). Administration will be continued until the time of manufacturing and distribution approval of OPC-41061 for ADPKD in Japan.

Timeline

Start
2009-11
Primary completion
2014-07
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Tolvaptan Small molecule 15 mg Oral