At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 40 enrolled
Drug / intervention
OPC-41061 +1 moredrug
Likely dose
OPC-41061 3.75 mgfrom 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 Multi-center, Double-blind, Parallel-arm Study to Investigate Pharmacodynamics and Pharmacokinetics of OPC-41061 in Patients With Hepatic Edema
In Brief
A Phase 3 clinical trial evaluating OPC-41061 for Cirrhosis. Completed, enrolled 40 participants across 1 site.
Detailed Summary
OPC-41061 at 3.75 mg/day or 7.5 mg/day will be orally administered once daily for 7 days to cirrhosis patients with ascites despite having received treatment with conventional diuretics and pharmacodynamics, pharmacokinetics, efficacy, and safety will be investigated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCirrhosis
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2010
First PostedMay 2010
Primary CompletionOct 2011
Study CompletionDec 2011
TodayJul 2026
First PostedMay 3, 2010
Enrollment StartFeb 1, 2010
Primary CompletionOct 1, 2011
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 16.2 years ago
Interventions
OPC-41061drug
Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
OPC-41061drug
Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days