check_circleStudy Completed

Heart failure

Bayer Identifier:

16815

ClinicalTrials.gov Identifier:

NCT01955694

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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
November 2013 - February 2015
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Sendai, 983-8520, Japan
Completed
Higashiibaraki, 311-3193, Japan
Withdrawn
Kamogawa, 296-0041, Japan
Completed
Sayama, 350-1305, Japan
Completed
Shinjuku-ku, 162-8666, Japan
Completed
Kawasaki, 211-8533, Japan
Completed
Yokohama, 245-8575, Japan
Completed
Hiratsuka, 254-8502, Japan
Completed
Kofu, 400-8506, Japan
Completed
Shizuoka, 420-8630, Japan
Completed
Toyota, 471-8513, Japan
Completed
Seto, 489-8642, Japan
Completed
Kusatsu, 525-8585, Japan
Completed
Kyoto, 607-8062, Japan
Completed
Osaka, 558-8558, Japan
Completed
Amagasaki, 660-8550, Japan
Completed
Okayama, 700-8607, Japan
Completed
Fukuoka, 810-0001, Japan
Completed
Chikushino, 818-8516, Japan
Completed
Kagoshima, 892-0853, Japan
Completed
Urasoe, 901-2132, Japan
Completed
Naha, 902-8511, Japan
Completed
Kamogawa, 296-8602, Japan
Withdrawn
Sayama, 350-1305, Japan
Completed
Shinjuku-ku, 162-8655, Japan
Completed
Kobe, 650-0047, Japan
Completed
Matsuyama, 790-0067, Japan
Completed
Naha, 900-0005, Japan
Completed
Kobe, 654-0155, Japan
Completed
Funabashi, 273-8588, Japan
Completed
Uji, 611-0041, Japan

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 10
    date_rangeTime Frame:
    From baseline to 90 days
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Change in serum potassium
    date_rangeTime Frame:
    From baseline to 90 days
    enhanced_encryption
    Safety Issue:
    Yes

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

Additional Information

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