At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 110 enrolled
Drug / intervention
OPC-41061(Tolvaptan)drug
Likely dose
OPC-41061(Tolvaptan) 15mgfrom 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 Double-blind, Placebo-controlled Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)
In Brief
A Phase 3 clinical trial evaluating OPC-41061(Tolvaptan) for Edema, Cardiac. Completed, enrolled 110 participants across 8 sites.
Detailed Summary
To evaluate the efficacy and safety of 7-day repeated oral administration of OPC-41061 15 mg or placebo in congestive heart failure (CHF) patients with extracellular volume expansion despite the use of a conventional diuretic.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEdema, Cardiac
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2007
First PostedApr 2007
Primary CompletionOct 2008
TodayJul 2026
First PostedApr 19, 2007
Enrollment StartApr 1, 2007
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 19.2 years ago
Interventions
OPC-41061(Tolvaptan)drug
0, 15mg of OPC-41061 per day for 7days p.o. administration