Autosomal dominant polycystic kidney disease (ADPKD)
Conditions
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who completed 5-day repeated administration and the follow-up observation in the preceding study (156-04-001) 2) 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
Exclusion criteria: 1) Patients with serum creatinine concentration of 2.5 mg/dL or higher at the screening examination 2) Patients with any of the following complications -Uncontrolled hypertension -Serious cardiovascular disease (eg. heart failure) or hepatic disease (eg. cirrhosis)" 3) 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) -Inability to personally give consent due to a mental disease " 4) Patients with SBP (in sitting position) <90 mm Hg (at screening examination) 5) Patients with history of massive bleeding or bleeding tendency 6) Patients with a history of drug or alcohol abuse within 6 months prior to the screening examination 7) Pregnant women, lactating women, or women who may become or plan to become pregnant 8) Patients who received any investigational drug other than OPC-41061 within 30 days prior to commencement of administration of OPC-41061 9) Any patient who, in the opinion of the principle investigator or subinvestigators, should not participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety 156 weeks: adverse events, pre-treatment adverse events, laboratory values, plasma AVP concentration, vital signs, body weight, and ECG Efficacy 156 weeks: combined renal volume (right and left kidneys) and renal function test Pharmacology 156weeks: urine osmolality | — |
Outcome results
None listed