Trial Condition(s):

Heart Failure

Phase IIb safety and efficacy study of BAY94-8862 in subjects with worsening chronic heart failure and left ventricular systolic dysfunction and either type 2 diabetes mellitus with or without chronic kidney disease or moderate chronic kidney disease alone (ARTS-HF Japan)

Bayer Identifier:

16815

ClinicalTrials.gov Identifier:

NCT01955694

EudraCT Number:

Not Available

Study Completed

Trial Purpose

This study will be conducted in subjects with clinical diagnosis of worsening chronic heart failure and either type 2 diabetes mellitus (DM) with or without chronic kidney disease (CKD) or moderate CKD alone treated with evidence-based therapy for heart failure (HF) for at least 3 months prior to emergency presentation to hospital using a multi-center, randomized, adaptive, double-blind, double-dummy, comparator-controlled, parallel-group design.
Primary objective of the study is to investigate efficacy [percentage of subjects with a relative decrease in N-terminal prohormone B-type natriuretic peptide (NT-proBNP) of more than 30% from baseline to Visit 10 (Day 90)] and safety of different oral doses of BAY94-8862 given once daily.

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
- 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
 - Addison’s disease

Trial Summary

Enrollment Goal
72
Trial Dates
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Phase
2
Could I receive a placebo?
Yes
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Sendai, Japan, 983-8520

Status
Completed
 
Locations

Investigative Site

Higashiibaraki, Japan, 311-3193

Status
Completed
 
Locations

Investigative Site

Sayama, Japan, 350-1305

Status
Completed
 
Locations

Investigative Site

Shinjuku-ku, Japan, 162-8666

Status
Completed
 
Locations

Investigative Site

Kawasaki, Japan, 211-8533

Status
Completed
 
Locations

Investigative Site

Yokohama, Japan, 245-8575

Status
Completed
 
Locations

Investigative Site

Hiratsuka, Japan, 254-8502

Status
Completed
 
Locations

Investigative Site

Kofu, Japan, 400-8506

Status
Completed
 
Locations

Investigative Site

Shizuoka, Japan, 420-8630

Status
Completed
 
Locations

Investigative Site

Toyota, Japan, 471-8513

Status
Completed
 
Locations

Investigative Site

Seto, Japan, 489-8642

Status
Completed
 
Locations

Investigative Site

Kusatsu, Japan, 525-8585

Status
Completed
 
Locations

Investigative Site

Kyoto, Japan, 607-8062

Status
Completed
 
Locations

Investigative Site

Osaka, Japan, 558-8558

Status
Completed
 
Locations

Investigative Site

Amagasaki, Japan, 660-8550

Status
Completed
 
Locations

Investigative Site

Okayama, Japan, 700-8607

Status
Completed
 
Locations

Investigative Site

Fukuoka, Japan, 810-0001

Status
Completed
 
Locations

Investigative Site

Chikushino, Japan, 818-8516

Status
Completed
 
Locations

Investigative Site

Kagoshima, Japan, 892-0853

Status
Completed
 
Locations

Investigative Site

Urasoe, Japan, 901-2132

Status
Completed
 
Locations

Investigative Site

Naha, Japan, 902-8511

Status
Completed
 
Locations

Investigative Site

Kamogawa, Japan, 296-8602

Status
Completed
 
Locations

Investigative Site

Shinjuku-ku, Japan, 162-8655

Status
Completed
 
Locations

Investigative Site

Kobe, Japan, 650-0047

Status
Completed
 
Locations

Investigative Site

Matsuyama, Japan, 790-0067

Status
Completed
 
Locations

Investigative Site

Naha, Japan, 900-0005

Status
Completed
 
Locations

Investigative Site

Kobe, Japan, 654-0155

Status
Completed
 
Locations

Investigative Site

Funabashi, Japan, 273-8588

Status
Completed
 
Locations

Investigative Site

Uji, Japan, 611-0041

Status
Completed
 

Trial Design