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 - Full Text View

Purpose

To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it is 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 will be compared to eplerenone, another marketed drug approved to treat heart failure.

Condition	Intervention	Phase
Heart Failure	Drug: BAY94-8862 Drug: Placebo Drug: Inspra (eplerenone)	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-blind, Double-dummy, Multi-center Study to Assess Safety and Efficacy of Different Oral Doses of BAY94-8862 in 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 Chronic Kidney Disease Alone Versus Eplerenone

Resource links provided by NLM:

MedlinePlus related topics: Chronic Kidney Disease Diabetes Diabetes Type 2 Heart Failure Potassium

Drug Information available for: Eplerenone

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Relative decrease in N-terminal prohormone B-type natriuretic peptide (NT-proBNP) [ Time Frame: From baseline to 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in serum potassium [ Time Frame: From baseline to 90 days ] [ Designated as safety issue: Yes ]
Change in blood pressure [ Time Frame: From baseline to 90 days ] [ Designated as safety issue: Yes ]
Change in heart rate [ Time Frame: From baseline to 90 days ] [ Designated as safety issue: Yes ]
Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 120 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1060
Study Start Date:	June 2013
Estimated Study Completion Date:	January 2015
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: BAY94-8862 [2.5 mg] + Placebo Oral - 2.5mg once daily (OD) for 30 days. Potential up-titration to 5mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.	Drug: BAY94-8862 Drug: Placebo
Experimental: BAY94-8862 [5 mg] + Placebo Oral - 5mg OD for 30 days. Potential up-titration to 10 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.	Drug: BAY94-8862 Drug: Placebo
Experimental: BAY94-8862 [7.5 mg] + Placebo Oral - 7.5mg OD for 30 days. Potential up-titration to 15 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.	Drug: BAY94-8862 Drug: Placebo
Experimental: BAY94-8862 [10 mg] + Placebo Oral - 10mg OD for 30 days. Potential up-titration to 20 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.	Drug: BAY94-8862 Drug: Placebo
Experimental: BAY94-8862 [15 mg] + Placebo Oral - 15mg OD for 30 days. Potential up-titration to 20 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.	Drug: BAY94-8862 Drug: Placebo
Active Comparator: Eplerenone [25 mg] + Placebo Oral - 25mg every other day (EOD). Potential up-titration to 25mg OD after 30 days and 50mg OD after 60 days.Placebo OD for 90 days.	Drug: Placebo Drug: Inspra (eplerenone)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men aged 18 years and older or postmenopausal women
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/1.73m2 </= eGFR </= 60 mL/min/1.73m2 (MDRD, Modification of Diet in Renal Disease Study Group) at screening
Left ventricular ejection fraction (LVEF) </= 40%
Serum potassium </= 5.0 mmol/L at screening
Systolic blood pressure >/= 90 mmHg without signs and symptoms of hypotension at the screening visit

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01807221

Contacts

Contact: Bayer Clinical Trials Contact		clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4')	(+)1-888-84 22937

Show 91 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bayer
ClinicalTrials.gov Identifier:	NCT01807221 History of Changes
Other Study ID Numbers:	14564, 2012-002627-15
Study First Received:	March 7, 2013
Last Updated:	June 7, 2013
Health Authority:	Austria: Austrian Medicines and Medical Devices Agency Australia: Department of Health and Ageing Therapeutic Goods Administration Canada: Health Canada Czech Republic: State Institute for Drug Control Denmark: Danish Health and Medicines Authority Finland: Finnish Medicines Agency France: Agence Nationale de Sécurité du Médicament et des produits de santé Germany: Federal Institute for Drugs and Medical Devices Greece: National Organization of Medicines Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines Israel: Ministry of Health Italy: The Italian Medicines Agency Lithuania: State Medicine Control Agency - Ministry of Health Netherlands: Medicines Evaluation Board (MEB) Norway: Norwegian Medicines Agency Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Portugal: INFARMED - National Authority of Medicines and Health Products South Africa: Medicines Control Council South Korea: Korea Food and Drug Administration (KFDA) Spain: Agencia Española de Medicamentos y Productos Sanitarios Sweden: Medical Products Agency United States: Food and Drug Administration Taiwan : Food and Drug Administration

Keywords provided by Bayer:

Heart Decompensation

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Failure
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Ventricular Dysfunction, Left
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases

Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency
Ventricular Dysfunction
Eplerenone
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013

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 (ARTS-HF)