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.

View Eligibility Criteria

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 Left ventricular ejection fraction (LVEF) Blood potassium 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

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

1066

Study ID:

NCT01807221

Recruitment Status:

Completed

Sponsor:

Bayer

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There are 166 Locations for this study

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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

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

1066

Study ID:

NCT01807221

Recruitment Status:

Completed

Sponsor:


Bayer

How clear is this clinincal trial information?

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