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 Diseas

• Status: Completed
• Trial end date: 2015-02-20

Summary

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.

• Phase: Phase 2

Details

• Lead Sponsor: Bayer
• Treatments: Eplerenone; Spironolactone