A Proof-of-concept Trial for OPC 131461 in Patients Hospitalized for Worsening Heart Failure
brief 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).
official title
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