CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 157 enrolled
Drug / intervention
OPC 131461 10mg group +4 moredrug
Likely dose
OPC 131461 10mg groupfrom 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.

Search/NCT05615363
NCT05615363Phase 2Completed

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Doseranging Trial of OPC-131461 in Cardiac Edema (Congestive Heart Failure [CHF])

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Nov 14, 2022·Updated Oct 20, 2025

In Brief

A Phase 2 clinical trial evaluating OPC 131461 10mg group, OPC 131461 5mg group, and 3 other interventions for Cardiac Edema (CHF). Completed, enrolled 157 participants across 1 site.

Detailed Summary

To investigate the dose response in respect of weight decrease following repeated oral administration of OPC-131461 at 1, 2, 5, and 10 mg or placebo in patients with CHF with volume overload despite having received diuretics other than vasopressin antagonists

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedNov 14, 2022
Enrollment StartJan 10, 2023
Primary CompletionOct 21, 2024
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 3.6 years ago

Interventions

OPC 131461 10mg groupdrug

OPC-131461 5 mg tablet x 2,once-daily oral administration for 14 days

OPC 131461 5mg groupdrug

OPC-131461 5 mg tablet and placebo tablet,once-daily oral administration for 14 days

OPC 131461 2mg groupdrug

OPC-131461 1 mg tablet x 2,once-daily oral administration for 14 days

OPC 131461 1mg groupdrug

OPC-131461 1 mg tablet and placebo tablet,once-daily oral administration for 14 days

Placebodrug

Placebo tablet,once-daily oral administration for 14 days