A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Treatments: Tolvaptan

Criteria

Inclusion Criteria:

• Patients who completed 5-day repeated administrations and the follow-up observation in the preceding study (156-04-001)

• Patients in whom the safety of repeated administration was confirmed based on the investigator's reports from the preceding study (156-04-001)

Exclusion Criteria:

• Patients with serum creatinine concentration of 2.5 mg/dL or higher at the screening examination

• Patients with any of the following complications

• Uncontrolled hypertension

• Serious cardiovascular disease (eg. heart failure) or hepatic disease (eg. cirrhosis)"

• Patients with any of the following complications or history thereof

• Clinically significant drug allergies (anaphylaxis) or hypersensitivity (especially, hypersensitivity to benzazepine derivatives or suspected hypersensitivity thereto)

• Inability to personally give consent due to a mental disease "

• Patients with SBP (in sitting position) <90 mm Hg (at screening examination)

• Patients with history of massive bleeding or bleeding tendency

• Patients with a history of drug or alcohol abuse within 6 months prior to the screening examination

• Pregnant women, lactating women, or women who may become or plan to become pregnant

• Patients who received any investigational drug other than OPC-41061 within 30 days prior to commencement of administration of OPC-41061

• Any patient who, in the opinion of the principle investigator or attending investigators, should not participate in the study