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]

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Autosomal Dominant Polycystic Kidney Disease

Interventions

Type	Name	Description
DRUG	OPC-41061	Repeated oral administration at doses of 15 mg twice daily (morning and evening)

Timeline

• Start date: 2009-11-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2009-12-01
• Last updated: 2018-09-11
• Results posted: 2018-07-27

Locations

1 site across 1 country: Japan