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:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Sendai, Japan, 983-8520 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Higashiibaraki, Japan, 311-3193 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sayama, Japan, 350-1305 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shinjuku-ku, Japan, 162-8666 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kawasaki, Japan, 211-8533 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yokohama, Japan, 245-8575 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hiratsuka, Japan, 254-8502 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kofu, Japan, 400-8506 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shizuoka, Japan, 420-8630 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toyota, Japan, 471-8513 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seto, Japan, 489-8642 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kusatsu, Japan, 525-8585 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kyoto, Japan, 607-8062 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka, Japan, 558-8558 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Amagasaki, Japan, 660-8550 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Okayama, Japan, 700-8607 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fukuoka, Japan, 810-0001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chikushino, Japan, 818-8516 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kagoshima, Japan, 892-0853 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Urasoe, Japan, 901-2132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Naha, Japan, 902-8511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kamogawa, Japan, 296-8602 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shinjuku-ku, Japan, 162-8655 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kobe, Japan, 650-0047 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Matsuyama, Japan, 790-0067 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Naha, Japan, 900-0005 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kobe, Japan, 654-0155 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Funabashi, Japan, 273-8588 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Uji, Japan, 611-0041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
6
Primary Outcome
- The percentage of subjects with a relative decrease in N-terminal prohormone B-type natriuretic peptide of more than 30% from baseline to Visit 10Timeframe: From baseline to 90 days
Secondary Outcome
- Change in serum potassiumTimeframe: From baseline to 90 days
Additional Information
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