Heart Failure Clinical Trial
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
Summary
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.
Eligibility Criteria
Inclusion Criteria:
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
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
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There are 166 Locations for this study
Birmingham Alabama, 35294, United States
La Jolla California, 92037, United States
Los Angeles California, 90033, United States
Jacksonville Florida, 32209, United States
Macon Georgia, 31201, United States
Baltimore Maryland, 21201, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Newark New Jersey, 07103, United States
Fairfield Ohio, 45014, United States
Darlinghurst New South Wales, 2010, Australia
Adelaide South Australia, 5042, Australia
Concord , 2139, Australia
Prahran , 3004, Australia
Krems an der Donau Niederösterreich, 3500, Austria
Linz Oberösterreich, 4010, Austria
Graz Steiermark, 8020, Austria
Graz Steiermark, 8036, Austria
Innsbruck Tirol, 6020, Austria
Salzburg , 5020, Austria
Wien , 1100, Austria
Burgas , 8018, Bulgaria
Pazardzhik , 4400, Bulgaria
Ruse , 7002, Bulgaria
Sofia , 1233, Bulgaria
Sofia , 1309, Bulgaria
Sofia , 1431, Bulgaria
Varna , 9010, Bulgaria
Calgary Alberta, T2N 4, Canada
Ottawa Ontario, K1Y 4, Canada
Toronto Ontario, M5B 1, Canada
Montreal Quebec, H1T 1, Canada
Montreal Quebec, H2W 1, Canada
Montreal Quebec, H3T 1, Canada
Saint-Jean-sur-Richelieu Quebec, J3A 1, Canada
Sherbrooke Quebec, J1H 5, Canada
Quebec , G1V 4, Canada
Jindrichuv Hradec , 377 0, Czechia
Ostrava , 728 8, Czechia
Praha 5 , 150 3, Czechia
Slany , 274 0, Czechia
Copenhagen Ø , 2100, Denmark
Esbjerg , 6700, Denmark
Glostrup , 2600, Denmark
Hellerup , 2900, Denmark
Herlev , 2730, Denmark
Hvidovre , 2650, Denmark
København NV , 2400, Denmark
Køge , 4600, Denmark
Svendborg , 5700, Denmark
Viborg , 8800, Denmark
Espoo , 02740, Finland
Helsinki , 00099, Finland
Rovaniemi , 96101, Finland
Turku , 20520, Finland
Bron , 69677, France
Nice , 06200, France
PARIS cedex 10 , 75475, France
Paris cedex 13 , 75013, France
Rouen , 76031, France
Toulouse , 31403, France
Vandoeuvre les Nancy , 54500, France
Würzburg Bayern, 97078, Germany
Frankfurt Hessen, 60389, Germany
Limburg Hessen, 65549, Germany
Göttingen Niedersachsen, 37099, Germany
Hannover Niedersachsen, 30625, Germany
Stade Niedersachsen, 21682, Germany
Bad Oeynhausen Nordrhein-Westfalen, 32545, Germany
Mönchengladbach Nordrhein-Westfalen, 41063, Germany
Homburg Saarland, 66421, Germany
Erfurt Thüringen, 99089, Germany
Berlin , 13353, Germany
Athens , 11526, Greece
Athens , 11527, Greece
Chaidari , 12462, Greece
Larissa , 41100, Greece
Nea Ionia / Athens , 14233, Greece
Budapest , 1027, Hungary
Budapest , 1085, Hungary
Budapest , 1097, Hungary
Nagykanizsa , 8800, Hungary
Szekesfehervar , 8000, Hungary
Afula , 18341, Israel
Ashkelon , 78306, Israel
Hadera , 38101, Israel
Haifa , 34362, Israel
Jerusalem , 91031, Israel
Kfar Saba , 44281, Israel
Nahariya , 22100, Israel
Petach Tikva , 49414, Israel
Rehovot , 76100, Israel
Tel Aviv , 64239, Israel
Zefat , 13110, Israel
Zerifin , 70300, Israel
Roma Lazio, 00163, Italy
Bergamo Lombardia, 24127, Italy
Milano Lombardia, 20149, Italy
Monza Brianza Lombardia, 20900, Italy
Foggia Puglia, 71100, Italy
Arezzo Toscana, 52040, Italy
Pisa Toscana, 56124, Italy
Perugia Umbria, 06129, Italy
Wonju Gang''weondo, 26426, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Kaunas , LT-44, Lithuania
Kaunas , LT-47, Lithuania
Kaunas , LT-50, Lithuania
Klaipeda , 92288, Lithuania
Klaipeda , LT-92, Lithuania
Vilnius , LT-08, Lithuania
Amsterdam , 1061 , Netherlands
Delft , 2625 , Netherlands
Groningen , 9700 , Netherlands
Groningen , 9728 , Netherlands
Hoogeveen , 7909 , Netherlands
Nijmegen , 6525 , Netherlands
Rotterdam , 3045 , Netherlands
Veldhoven , 5504 , Netherlands
Zutphen , 7207 , Netherlands
Stavanger , 4011, Norway
Bialystok , 15-27, Poland
Bydgoszcz , 85-68, Poland
Gdansk , 80-95, Poland
Katowice , 40-63, Poland
Kielce , 25-73, Poland
Krakow , 31-12, Poland
Szczecin , 70-96, Poland
Warszawa , 04-62, Poland
Wroclaw , 50-98, Poland
Almada , 2801-, Portugal
Faro , 8000-, Portugal
Lisboa , 1449-, Portugal
Lisboa , 1500-, Portugal
Lisboa , 1649-, Portugal
Porto , P-420, Portugal
Petoria Gauteng, , South Africa
Isipingo Rail Kwazulu-Natal, 4110, South Africa
Merebank Kwazulu-Natal, 4052, South Africa
Tongaat Kwazulu-Natal, 4400, South Africa
Cape Town Western Cape, 7500, South Africa
Kuils River Western Cape, 7580, South Africa
Pinelands Western Cape, 7405, South Africa
Somerset West Western Cape, 7130, South Africa
Worcester Western Cape, 6850, South Africa
Olot Girona, 17800, Spain
Majadahonda Madrid, 28222, Spain
El Palmar Murcia, 30120, Spain
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Madrid , 28041, Spain
Valencia , 46010, Spain
Valencia , 46026, Spain
Falun , 791 8, Sweden
Göteborg , 416 8, Sweden
Stockholm , 118 8, Sweden
Stockholm , 141 8, Sweden
Stockholm , 182 8, Sweden
Umeå , 901 8, Sweden
Örebro , 701 8, Sweden
New Taipei City , 220, Taiwan
Taipei , 10002, Taiwan
Taipei , 11217, Taiwan
Taipei , , Taiwan
Taizung , 402, Taiwan
Ankara , 06100, Turkey
Ankara , 06500, Turkey
Ankara , , Turkey
Antalya , 07003, Turkey
Izmir , 35100, Turkey
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