At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 162 enrolled
Drug / intervention
OPC-41061 +1 moredrug
Likely dose
OPC-41061 7.5 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 Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Investigate the Efficacy of OPC-41061 Administered at a Dose of 7.5 mg in Patients With Hepatic Edema
In Brief
A Phase 3 clinical trial evaluating OPC-41061 and Placebo for Cirrhosis. Completed, enrolled 162 participants across 8 sites.
Detailed Summary
OPC-41061 at 7.5 mg/day or placebo will be orally administered once daily for 7 days to cirrhosis patients with ascites despite having received treatment with conventional diuretics and the change in body weight from baseline at the time of the final administration will be compared between the two groups.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCirrhosis
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2009
First PostedJan 2010
Primary CompletionFeb 2012
TodayJul 2026
First PostedJan 15, 2010
Enrollment StartDec 1, 2009
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 16.5 years ago
Interventions
OPC-41061drug
Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
Placebodrug
Once-daily oral administration of placebo after breakfast for 7 days