NCT06795399

A Proof-of-concept Trial for OPC 131461 in Patients Hospitalized for Worsening Heart Failure

A Phase 2, Randomized, Double-blind, Placebo-controlled, Proof of Concept Trial for OPC-131461 in Patients Hospitalized for Worsening Heart Failure With Laboratory Evidence of Incomplete Decongestion Following Urgent Decongestive Therapy

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to compare relative changes in blood N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels after 30 days of treatment in participants with worsening heart failure (WHF), who are treated with either OPC-131461 or placebo.

Detailed description

Each participant in this trial is expected to participate in the following periods of the trial: * Screening/qualification period: up to 48 hours (2 days) * Double-blind treatment period: 30 days * Safety follow-up period: 7 days * Vital status follow-up period: 6 months Eligible participants will be randomized to receive the study drug (1 of 2 dose levels \[5 milligrams (mg) or 10 mg\] of OPC-131461 tablets or placebo) in a 1:1:1 ratio. Overall, the trial duration is expected to be approximately 210 days (7 months).

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	OPC-131461	OPC-131461 will be administered as oral tablets.
DRUG	Placebo	OPC-131461 matched placebo will be administered as oral tablets.

Timeline

• Start date: 2025-04-30
• Primary completion: 2025-05-25
• Completion: 2025-05-25
• First posted: 2025-01-28
• Last updated: 2026-04-17

Regulatory

• FDA-regulated drug study