A Randomized, Double-blind, Double-dummy, Multi-center Study to Assess Safety and Efficacy of BAY94-8862 in Japanese Subjects With Emergency Presentation at the Hospital Because of Worsening Chronic Heart Failure With Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Moderate Chronic Kidney Disease Alone Versus Eplerenone

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222262

Enrollment

Registered

2013-10-28

Start date

2013-11-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Interventions

Experimental: BAY94-8862 (2.5 mg) 2.5 mg BAY94-8862 tablet and placebo capsule once daily in the morning, with possible up-titration to 5 mg once daily at Visit 6 (Day 30), and sham up-titration at Vi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Subjects with worsening chronic heart failure requiring emergency presentation to hospital and treatment with intravenous (IV) diuretics at hospital - Subjects with either type 2 DM or moderate CKD

Exclusion criteria

Exclusion criteria: - Acute de-novo heart failure or acute inflammatory heart disease, e.g. acute myocarditis - Acute coronary syndrome (ACS) (elevated cardiac troponins which are not caused by an ACS are not an exclusion criterion) in the last 30 days prior to the screening visit - Cardiogenic shock - Valvular heart disease requiring surgical intervention during the course of the study - Subjects with left ventricular assistance device or waiting for heart transplantation - Stroke or transient ischemic cerebral attack in the last 3 months prior to the screening visit - Addisons disease

Design outcomes

Primary

Measure	Time frame
The percentage of subjects with a relative decrease in N-terminal prohormone B-type natriuretic peptide of more than 30% from baseline to Visit 10	—

Secondary

Measure	Time frame
Change in serum potassium	—

Countries

Japan

Contacts

Public Contactcontact Dedicated

Bayer Yakuhin, Ltd.

byl_ct_contact@bayer.com+81-6-6133-6363

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026