NCT05615363

A Dose-ranging Trial of OPC-131461 in Cardiac Edema (Congestive Heart Failure [CHF])

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cardiac Edema (CHF)

Interventions

Type	Name	Description
DRUG	OPC 131461 10mg group	OPC-131461 5 mg tablet x 2，once-daily oral administration for 14 days
DRUG	OPC 131461 5mg group	OPC-131461 5 mg tablet and placebo tablet，once-daily oral administration for 14 days
DRUG	OPC 131461 2mg group	OPC-131461 1 mg tablet x 2，once-daily oral administration for 14 days
DRUG	OPC 131461 1mg group	OPC-131461 1 mg tablet and placebo tablet，once-daily oral administration for 14 days
DRUG	Placebo	Placebo tablet，once-daily oral administration for 14 days

Timeline

• Start date: 2023-01-10
• Primary completion: 2024-10-21
• Completion: 2024-10-21
• First posted: 2022-11-14
• Last updated: 2025-10-20
• Results posted: 2025-10-20

Locations

1 site across 1 country: Japan