Phase IIb Safety and Efficacy Study of Different Oral Doses 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 Chronic Kidney Disease Alone

Completed · Phase 2 · Has a placebo group

Conditions studied: Heart Failure

In brief

To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic kidney disease or kidney disease alone. These treatment doses were compared to eplerenone, another marketed drug approved to treat heart failure.

Key facts

Study ID

NCT01807221

Run by

Bayer

People needed

1066

Starts

2013-06-17

Expected to finish

2014-12-09

Last updated by the study team

2021-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women aged 18 years and older. The lower age limit may be higher if legally required in the participating country
• Women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active
• Subjects with worsening chronic heart failure requiring emergency presentation to hospital and treatment with intravenous diuretics at hospital
• Subjects with clinical diagnosis of chronic heart failure (CHF) either ischemic or non ischemic, New York Heart Association (NYHA) functional class II-IV
• Subjects with type 2 diabetes mellitus and / or
• Subjects with 30 mL/min/1.73m\^2 </= eGFR </= 60 mL/min/1.73m\^2 (MDRD, Modification of Diet in Renal Disease Study Group) at screening
• Left ventricular ejection fraction (LVEF) </= 40%
• Blood potassium </= 5.0 mmol/L at screening
• Systolic blood pressure >/= 90 mmHg without signs and symptoms of hypotension at the screening visit

You may not qualify if…

• Acute de-novo heart failure or acute inflammatory heart disease, e.g. acute myocarditis
• Acute coronary syndrome (ACS) in last 30 days prior to screening
• Cardiogenic shock
• Valvular heart disease requiring surgical intervention during the course of the study
• Stroke or transient ischemic cerebral attack in the last 3 months prior to the screening visit
• Concomitant treatment with any mineralocorticoid receptor antagonist (MRA), renin inhibitor, or potassium-sparing diuretic

Where it is running

• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — Jacksonville, Florida, United States
• Study site — Macon, Georgia, United States
• Study site — Baltimore, Maryland, United States
• Study site — Detroit, Michigan, United States
• Study site — Detroit, Michigan, United States
• Study site — Newark, New Jersey, United States
• Study site — Fairfield, Ohio, United States
• Study site — Darlinghurst, New South Wales, Australia
• Study site — Adelaide, South Australia, Australia
• Study site — Concord, Australia
• Study site — Prahran, Australia
• Study site — Krems, Lower Austria, Austria
• Study site — Graz, Styria, Austria
• Study site — Graz, Styria, Austria
• Study site — Innsbruck, Tyrol, Austria
• Study site — Linz, Upper Austria, Austria
• Study site — Salzburg, Austria
• Study site — Vienna, Austria
• Study site — Burgas, Bulgaria
• Study site — Pazardzhik, Bulgaria
• Study site — Rousse, Bulgaria
• Study site — Sofia, Bulgaria
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.