At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 52 enrolled
Drug / intervention
OPC-41061 （Tolvaptan)drug
Likely dose
OPC-41061 （Tolvaptan) 30mgfrom 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.
Phase 3 Open-label, Study of OPC-41061 in Subjects With Cardiac-induced Edema (Congestive Heart Failure) - an Investigation of the Safety of Treatment Beyond 7 Days and the Effect of Dose Escalation to 30 mg
In Brief
A Phase 3 clinical trial evaluating OPC-41061 （Tolvaptan) for Cardiac Edema. Completed, enrolled 52 participants across 6 sites.
Detailed Summary
To investigate the plasma drug level, efficacy, and safety of 7-day repeated oral administration of OPC-41061 at 15 mg/day (treatment period 1) and subsequent 7-day repeated administration of OPC-41061 at 15 mg/day or 30 mg/day if diuretic effect is insufficient (treatment period 2) in congestive heart failure (CHF) patients with extracellular volume expansion despite conventional diuretic therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiac Edema
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2007
First PostedOct 2007
Primary CompletionFeb 2009
TodayJul 2026
First PostedOct 16, 2007
Enrollment StartOct 1, 2007
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.7 years ago
Interventions
OPC-41061 （Tolvaptan)drug
15-30mg/day,daily for 14days