At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 124 enrolled
Drug / intervention
OPC-41061 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Multicenter, Placebo-controlled, Double-blind, Randomized, Parallel-group Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration
In Brief
A Phase 2 clinical trial evaluating OPC-41061 and Placebo for Chronic Renal Failure. Completed, enrolled 124 participants across 4 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Renal Failure
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartDec 2014
First PostedJan 2015
Primary CompletionMay 2016
TodayJul 2026
First PostedJan 6, 2015
Enrollment StartDec 1, 2014
Primary CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 11.5 years ago
Interventions
OPC-41061drug
OPC-41061drug
Placebodrug