Clinical Trial: A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]
Brief 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.
Detailed Summary:
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Current Primary Outcome:
- combined renal volume (right and left kidneys) and renal function test [ Time Frame: Every 12 or 48 weeks ]
- adverse events [ Time Frame: Every 4, 12, or 24 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Otsuka Pharmaceutical Co., Ltd.
Dates:
Date Received: November 27, 2009
Date Started: November 2009
Date Completion:
Last Updated: October 16, 2015
Last Verified: October 2015
