drugset / Trial / NCT02331680

A Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration

NCT02331680

Phase 2 Completed 124 enrolled Otsuka Pharmaceutical Co., Ltd.
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a study to investigate the efficacy and safety of OPC-41061 by 24-week oral administration of OPC-41061 at 15-mg or 30-mg or placebo in patients with chronic renal failure who are undergoing hemodialysis or hemodiafiltration and who have daily urine volume of at least 500 mL/day.

Timeline

Start
2014-12
Primary completion
2016-05
Completion
2016-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Tolvaptan Small molecule 15 mg Oral
Subject Tolvaptan Small molecule 30 mg Oral