Clinical Trial: A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]
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) [Extension of Study 156-04-001]
Brief Summary: Investigation into the long-term safety and efficacy of OPC-41061 in repeated oral administrations at doses of 15 mg twice daily in patients with ADPKD who completed the preceding dose-finding study (156-04-001).
Detailed Summary: Investigation into the long-term safety and efficacy of OPC-41061 in repeated oral administrations at doses of 15 mg twice daily in patients with ADPKD who completed the preceding dose-finding study (156-04-001).
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Current Primary Outcome:
- Safety: adverse events, laboratory values, plasma AVP concentration, vital signs, body weight, and ECG [ Time Frame: 156 weeks ]
- Efficacy: combined renal volume (right and left kidneys) and renal function test [ Time Frame: 156 weeks ]
- Pharmacology: urine osmolality [ Time Frame: 156 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Otsuka Pharmaceutical Co., Ltd.
Dates:
Date Received: February 9, 2009
Date Started: April 2006
Date Completion:
Last Updated: April 7, 2011
Last Verified: April 2011
