At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 45 enrolled
Drug / intervention
OPC-61815 injectiondrug
Likely dose
OPC-61815 injection 8 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, Open-label, Uncontrolled Clinical Trial to Confirm the Tolerability of OPC-61815 in Patients With Congestive Heart Failure Who Have Difficulty With or Are Incapable of Oral Intake
In Brief
A Phase 3 clinical trial evaluating OPC-61815 injection for Congestive Heart Failure. Completed, enrolled 45 participants across 1 site.
Detailed Summary
To confirm the tolerability of intravenous administration of OPC-61815 at 8 or 16 mg once daily for a maximum of 5 days to CHF patients with volume overload despite having received diuretics (injection) other than vasopressin antagonists and who have difficulty with or are incapable of oral intake.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongestive Heart Failure
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedMay 2019
Enrollment StartJun 2019
Primary CompletionJun 2020
TodayJul 2026
First PostedMay 23, 2019
Enrollment StartJun 17, 2019
Primary CompletionJun 30, 2020
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 7.1 years ago
Interventions
OPC-61815 injectiondrug
Intravenous administration of OPC-61815 at 8 mg or 16 mg once daily for a maximum of 5 days. Starting with 8mg, increase the dose to 16mg on Day 2 or Day 3, according to the dose escalation criteria.