At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 104 enrolled
Drug / intervention
OPC-41061 7.5mg +3 moredrug
Likely dose
OPC-41061 7.5mgfrom 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 Dose-defining Study of OPC-41061 in Treatment of Hepatic Edema
In Brief
A Phase 2 clinical trial evaluating OPC-41061 7.5mg, OPC-41061 placebo, and 2 other interventions for Cirrhosis. Completed, enrolled 104 participants across 7 sites.
Detailed Summary
To investigate the dose response for changes from baseline in body weight as a primary endpoint and to investigate improvement in ascites, abdominal circumference, lower-limb edema, and pleural effusion as secondary endpoints in seven-day repeated oral administration of OPC-41061 at 7.5, 15, and 30 mg/day or placebo in cirrhosis patients with ascites despite taking conventional diuretics.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCirrhosis
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2007
Enrollment StartJun 2007
Primary CompletionJan 2009
TodayJul 2026
First PostedMay 28, 2007
Enrollment StartJun 1, 2007
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 19.1 years ago
Interventions
OPC-41061 7.5mgdrug
7.5mg, 1 tablet a day
OPC-41061 placebodrug
placebo, 1 tablet a day
OPC-41061 15mgdrug
15mg, 1 tablet a day
OPC-41601 30mgdrug
30mg, 1 tablet a day