Overview

Open-label Dose-finding Trial of OPC-41061 in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis

Status:
Completed
Trial end date:
2014-08-01
Target enrollment:
Participant gender:
Summary
To investigate the efficacy, pharmacokinetics, pharmacodynamics, and safety of OPC-41061 in patients with chronic renal failure who are undergoing peritoneal dialysis, using daily urine volume, body weight, and edematous conditions as parameters and conducting dose escalation every 2 days until reaching the dose that achieves urine volume increase and then performing 5-day repeated administration at the fixed dose, the final dose used in the dose escalation period.
Phase:
Phase 2
Details
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Treatments:
Tolvaptan