A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Reduced Ejection Fraction
NCT ID: NCT02992288
Last Updated: 2019-04-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
427 participants
INTERVENTIONAL
2017-02-22
2018-05-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Neladenoson bialanate (BAY1067197) (5 mg)
Chronic heart failure with reduced ejection fraction
Neladenoson bialanate (BAY1067197)
5 mg orally once daily for 20 weeks
Neladenoson bialanate (BAY1067197) (10 mg)
Chronic heart failure with reduced ejection fraction
Neladenoson bialanate (BAY1067197)
10 mg orally once daily for 20 weeks
Neladenoson bialanate (BAY1067197) (20 mg)
Chronic heart failure with reduced ejection fraction
Neladenoson bialanate (BAY1067197)
20 mg orally once daily for 20 weeks
Neladenoson bialanate (BAY1067197) (30 mg)
Chronic heart failure with reduced ejection fraction
Neladenoson bialanate (BAY1067197)
30 mg orally once daily for 20 weeks
Neladenoson bialanate (BAY1067197) (40 mg)
Chronic heart failure with reduced ejection fraction
Neladenoson bialanate (BAY1067197)
40 mg orally once daily for 20 weeks
Placebo
Chronic heart failure with reduced ejection fraction
Placebo
Orally once daily for 20 weeks
Interventions
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Neladenoson bialanate (BAY1067197)
5 mg orally once daily for 20 weeks
Neladenoson bialanate (BAY1067197)
10 mg orally once daily for 20 weeks
Neladenoson bialanate (BAY1067197)
20 mg orally once daily for 20 weeks
Neladenoson bialanate (BAY1067197)
30 mg orally once daily for 20 weeks
Neladenoson bialanate (BAY1067197)
40 mg orally once daily for 20 weeks
Placebo
Orally once daily for 20 weeks
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of chronic heart failure (CHF), NYHA ( New York Heart Association ) class II-IV, LVEF ≤ 35% and elevated NT-proBNP
Exclusion Criteria
* Requirement of any intravenous (IV) treatments following 48 hours prior to randomization
* Mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device)
* Any cause of chronic heart failure other than ischemic cardiomyopathy and idiopathic dilated cardiomyopathy
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Southwest Florida Research
Naples, Florida, United States
Henry Ford Health System
Detroit, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
St. Louis Heart & Vascular, PC
St Louis, Missouri, United States
Glacier View Research Institute-Cardiology
Kalispell, Montana, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
St. Elizabeth Youngstown Hospital
Youngstown, Ohio, United States
Tennessee Center for Clinical Trials
Tullahoma, Tennessee, United States
East Texas Cardiology
Houston, Texas, United States
AZ St-Jan Brugge Oostende AV
Bruges, , Belgium
Grand Hôpital de Charleroi
Gilly, , Belgium
AZ Delta
Roeselare, , Belgium
AZ Turnhout
Turnhout, , Belgium
Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik
Pernik, , Bulgaria
Specialized Hospital for Actrive Treatm of Card - Pleven
Pleven, , Bulgaria
NMTH Tzar Boris III
Sofia, , Bulgaria
UMHAT Tsaritsa Joanna-ISUL EAD Sofia
Sofia, , Bulgaria
Multiprofile Hospital for Active Treatment Sveta Sofia
Sofia, , Bulgaria
MHAT Dr Stefan Cherkezov
Veliko Tarnovo, , Bulgaria
Medizinische Hochschule Hannover (MHH)
Hanover, Lower Saxony, Germany
Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)
Bad Oeynhausen, North Rhine-Westphalia, Germany
St.-Johannes-Hospital Dortmund
Dortmund, North Rhine-Westphalia, Germany
Kliniken Maria Hilf GmbH
Mönchengladbach, North Rhine-Westphalia, Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
Charité Campus Virchow-Klinikum (CVK)
Berlin, , Germany
KAT General Hospital of Athens
Kifisia / Athens, Attica, Greece
G. Gennimatas General State Hospital of Athens
Athens, , Greece
Thriassio General Hospital of Elefsina
Elefsina, , Greece
Konstantopoulio General Hospital of Nea Ionia - Agia Olga
Nea Ionia / Athens, , Greece
Hippokration General Hospital of Thessaloniki
Thessaloniki, , Greece
Barzilai Medical Center
Ashkelon, , Israel
Hillel Yaffe Medical Center
Hadera, , Israel
Rambam Health Corporation
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Hadassah University Hospital Mount Scopus
Jerusalem, , Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
Assaf Harofeh Medical Center
Zrifin, , Israel
A.O.U. Policlinico Federico II Napoli
Napoli, Campania, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Rome, Lazio, Italy
ASST Papa Giovanni XXIII
Bergamo, Lombardy, Italy
ASST Spedali Civili di Brescia
Brescia, Lombardy, Italy
IRCCS Centro Cardiologico Fondazione Monzino
Milan, Lombardy, Italy
AUSL 8 Arezzo
Arezzo, Tuscany, Italy
Gunma University Hospital
Maebashi, Gunma, Japan
National Hospital Organization Takasaki General Medical C
Takasaki, Gunma, Japan
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki, Hyōgo, Japan
National hospital Organization Mito Medical Center
Higashiibaraki, Ibaraki, Japan
R.I.A.C Naha City Hospital
Naha, Okinawa, Japan
Kishiwada Tokushukai Hospital
Kishiwada, Osaka, Japan
Takatsuki Red Cross Hospital
Takatsuki, Osaka, Japan
Minamino Cardiovascular Hospital
Hachiōji, Tokyo, Japan
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Hiroshima University Hospital
Hiroshima, , Japan
Okayama Rosai Hospital
Okayama, , Japan
Osaka General Medical Center
Osaka, , Japan
Toyama Prefectural Central Hospital
Toyama, , Japan
Onze Lieve Vrouwe Gasthuis
Amsterdam, , Netherlands
Ziekenhuis Rijnstate
Arnhem, , Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
KLIMED Marek Klimkiewicz
Bialystok, , Poland
CLINICAL MEDICAL RESEARCH Sp. z o. o.
Katowice, , Poland
Szpital Specjalistyczny im. J. Dietla
Krakow, , Poland
Nzoz Salus
Lodz, , Poland
Szpital Kliniczny Przemienienia Panskiego
Poznan, , Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, , Poland
IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ
Wroclaw, , Poland
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
Hospital Universitario "Virgen de la Arrixaca"
El Palmar, Murcia, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Clínico Universitario San Carlos
Madrid, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
Countries
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References
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Voors AA, Bax JJ, Hernandez AF, Wirtz AB, Pap AF, Ferreira AC, Senni M, van der Laan M, Butler J; PANTHEON Investigators. Safety and efficacy of the partial adenosine A1 receptor agonist neladenoson bialanate in patients with chronic heart failure with reduced ejection fraction: a phase IIb, randomized, double-blind, placebo-controlled trial. Eur J Heart Fail. 2019 Nov;21(11):1426-1433. doi: 10.1002/ejhf.1591. Epub 2019 Sep 16.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
Other Identifiers
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2016-003839-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15128
Identifier Type: -
Identifier Source: org_study_id
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