Heart Failure Clinical Trial

Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure With Reduced Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-REDUCED)

Summary

Objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard therapy for heart failure with reduced ejection fraction (HFrEF).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Worsening chronic heart failure (WCHF) requiring hospitalization (or intravenous diuretic treatment for HF without hospitalization) with initiation of study treatment after clinical stabilization
Left ventricular ejection fraction (LVEF) <45% by echocardiography at randomization

Exclusion Criteria:

Intravenous inotropes at any time after hospitalization

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

456

Study ID:

NCT01951625

Recruitment Status:

Completed

Sponsor:

Bayer

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There are 154 Locations for this study

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Fountain Valley California, 92708, United States

Wilmington Delaware, 19803, United States

Fort Lauderdale Florida, 33308, United States

Jacksonville Florida, 32209, United States

Naples Florida, 34102, United States

Atlanta Georgia, 30342, United States

Macon Georgia, 31201, United States

New Orleans Louisiana, 70112, United States

Detroit Michigan, 48202, United States

Minneapolis Minnesota, 55422, United States

Jackson Mississippi, 39216, United States

Buffalo New York, 14215, United States

Columbus Ohio, 43210, United States

Fairfield Ohio, 45014, United States

Charleston South Carolina, 29425, United States

Germantown Tennessee, 38138, United States

Nashville Tennessee, 37232, United States

Milwaukee Wisconsin, 53215, United States

Darlinghurst New South Wales, 2010, Australia

Hobart Tasmania, 7000, Australia

Prahran Victoria, 3181, Australia

St. Pölten Niederösterreich, 3100, Austria

Linz Oberösterreich, 4020, Austria

Graz Steiermark, 8036, Austria

Salzburg , 5020, Austria

Wien , 1220, Austria

Brugge , 8000, Belgium

Bruxelles - Brussel , 1200, Belgium

Gent , 9000, Belgium

Gilly , 6060, Belgium

HUY , 4500, Belgium

Mechelen , 2800, Belgium

MOL , 2400, Belgium

Roeselare , 8800, Belgium

Sofia , 1202, Bulgaria

Sofia , 1233, Bulgaria

Sofia , 1309, Bulgaria

Sofia , 1527, Bulgaria

Stara Zagora , 6000, Bulgaria

Toronto Ontario, M5B 1, Canada

Montreal Quebec, H1T 1, Canada

Montreal Quebec, H2W 1, Canada

Saint-Jean-sur-Richelieu Quebec, J3A 1, Canada

Sherbrooke Quebec, J1G 2, Canada

Quebec , G1V 4, Canada

Hradec kralove , 500 0, Czechia

Kromeriz , 767 0, Czechia
Fakultni nemocnice Ostrava
Ostrava , 708 5, Czechia

Praha 10 , 10034, Czechia

Praha 2 , 12808, Czechia

Praha 4 , 140 2, Czechia

Praha 6 , 169 0, Czechia

Slany , 274 0, Czechia

Aalborg , 9000, Denmark

Aarhus N , 8200, Denmark

Hellerup , DK-29, Denmark

Viborg , 8800, Denmark

BRON Cedex , 69677, France

La Tronche , 38700, France

Lille Cedex , 59037, France

Paris Cedex 15 , 75908, France

Pessac , 33604, France

Rouen , 76031, France

München Bayern, 80331, Germany

Bad Homburg Hessen, 61348, Germany

Frankfurt Hessen, 60596, Germany

Greifswald Mecklenburg-Vorpommern, 17475, Germany

Hannover Niedersachsen, 30625, Germany

Köln Nordrhein-Westfalen, 50924, Germany

Münster Nordrhein-Westfalen, 48149, Germany

Homburg Saarland, 66424, Germany

Erfurt Thüringen, 99089, Germany

Hamburg , 20246, Germany

Athens , 11527, Greece

Nea Ionia , 14233, Greece

Budapest , 1032, Hungary

Kistarcsa , H-214, Hungary

Szekesfehervar , 8000, Hungary

Afula , 18341, Israel

Ashkelon , 78306, Israel

Hadera , 38101, Israel

Jerusalem , 91031, Israel

Petah Tikva , 49414, Israel

Rehovot , 76100, Israel

Tel Aviv , 64239, Israel

Tiberias , 15280, Israel

Zrifin , 70300, Israel

Bergamo Lombardia, 24127, Italy

Brescia Lombardia, 25123, Italy

Como Lombardia, 22020, Italy

Milano Lombardia, 20017, Italy

Milano Lombardia, 20138, Italy

Milano Lombardia, 20149, Italy

Pavia Lombardia, 27100, Italy

Ancona Marche, 60126, Italy

Arezzo Toscana, 52040, Italy

Verona Veneto, 37045, Italy

Iizuka Fukuoka, 820-8, Japan

Himeji Hyogo, 670-0, Japan

Kanazawa Ishikawa, 920-8, Japan

Sagamihara Kanagawa, 252-5, Japan

Yokohama Kanagawa, 236-0, Japan

Yokosuka Kanagawa, 238-8, Japan

Sendai Miyagi, 981-3, Japan

Naha Okinawa, 902-8, Japan

Takatsuki Osaka, 569-1, Japan

Yao Osaka, 581-0, Japan

Ureshino Saga, 843-0, Japan

Komatsushima Tokushima, 773-8, Japan

Meguro-ku Tokyo, 152-8, Japan

Minato-ku Tokyo, 106-0, Japan

Fukui , 910-8, Japan

Hiroshima , 734-8, Japan

Kumamoto , 862-8, Japan

Nagasaki , 850-8, Japan

Tokushima , 770-8, Japan

Toyama , 930-8, Japan

Seoul , 138-7, Korea, Republic of

Amsterdam , 1105 , Netherlands

Deventer , 7416 , Netherlands

Heerenveen , 8441 , Netherlands

Leeuwarden , 8901 , Netherlands

Veldhoven , 5504 , Netherlands

Bialystok , 15-27, Poland

Krakow , 31-20, Poland

Legnica , 59-22, Poland

Lodz , 92-21, Poland

Olsztyn , 10-01, Poland

Poznan , 61-84, Poland

Warszawa , 02-50, Poland

Singapore , 11922, Singapore

Singapore , 16960, Singapore

Singapore , 30843, Singapore

Singapore , 76882, Singapore

L'Hospitalet de Llobregat Barcelona, 08907, Spain

Santander Cantabria, 39008, Spain

Majadahonda Madrid, 28222, Spain

Barcelona , 08003, Spain

Barcelona , 08023, Spain

Valencia , 46010, Spain

Valencia , 46026, Spain

Helsingborg , 251 8, Sweden

Karlstad , 651 8, Sweden

Linköping , 581 8, Sweden

Malmö , 205 0, Sweden

Stockholm , 118 8, Sweden

Örebro , 701 8, Sweden

Liestal Basel-Landschaft, 4410, Switzerland

Bruderholz , 4101, Switzerland

Lugano , 6900, Switzerland

Zürich , 8091, Switzerland

Kaohsiung , 813, Taiwan

New Taipei City , 220, Taiwan

Taipei , 10016, Taiwan

Taipei , 11217, Taiwan

Chesterfield Derbyshire, S44 5, United Kingdom

Stevenage Hertfordshire, SG1 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

456

Study ID:

NCT01951625

Recruitment Status:

Completed

Sponsor:


Bayer

How clear is this clinincal trial information?

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