check_circleStudy Completed
Heart Failure
Bayer Identifier:
14564
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
Trial purpose
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.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
1066Trial Dates
June 2013 - December 2014Phase
Phase 2Could I Receive a placebo
YesProducts
Finerenone (BAY94-8862)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Espoo, 02740, Finland | |
Completed | Helsinki, 00099, Finland | |
Completed | Turku, 20520, Finland | |
Withdrawn | Jyväskylä, 40620, Finland | |
Completed | Rovaniemi, 96101, Finland | |
Completed | Rouen, 76031, France | |
Completed | TOULOUSE, 31403, France | |
Completed | Paris cedex 13, 75013, France | |
Completed | Bron, 69677, France | |
Withdrawn | CRETEIL, 94000, France | |
Completed | PARIS cedex 10, 75475, France | |
Completed | Vandoeuvre les Nancy, 54500, France | |
Completed | Hannover, 30625, Germany | |
Completed | Berlin, 13353, Germany | |
Completed | Homburg, 66421, Germany | |
Completed | Mönchengladbach, 41063, Germany | |
Completed | Erfurt, 99089, Germany | |
Completed | Vilnius, LT-08661, Lithuania | |
Completed | Kaunas, LT-50161, Lithuania | |
Completed | Kaunas, LT-44320, Lithuania | |
Completed | Kaunas, LT-47144, Lithuania | |
Completed | Klaipeda, LT-92288, Lithuania | |
Completed | Klaipeda, 92288, Lithuania | |
Completed | Chaidari, 12462, Greece | |
Completed | Athens, 11526, Greece | |
Completed | Athens, 11527, Greece | |
Completed | Göttingen, 37099, Germany | |
Withdrawn | Bochum, 44789, Germany | |
Completed | Copenhagen Ø, 2100, Denmark | |
Completed | Hellerup, 2900, Denmark | |
Completed | København NV, 2400, Denmark | |
Completed | Hvidovre, 2650, Denmark | |
Completed | Herlev, 2730, Denmark | |
Completed | Svendborg, 5700, Denmark | |
Withdrawn | Odense, 5000, Denmark | |
Completed | Køge, 4600, Denmark | |
Completed | Viborg, 8800, Denmark | |
Completed | Bergamo, 24127, Italy | |
Completed | Monza Brianza, 20900, Italy | |
Completed | Milano, 20149, Italy | |
Completed | Foggia, 71100, Italy | |
Completed | Roma, 00163, Italy | |
Completed | Arezzo, 52044, Italy | |
Completed | Würzburg, 97078, Germany | |
Completed | Bad Oeynhausen, 32545, Germany | |
Completed | Stavanger, 4011, Norway | |
Withdrawn | Haugesund, 5504, Norway | |
Withdrawn | Tønsberg, 3116, Norway | |
Completed | Wien, 1100, Austria | |
Withdrawn | Wien, 1160, Austria | |
Completed | Salzburg, 5020, Austria | |
Completed | Krems an der Donau, 3500, Austria | |
Completed | Linz, 4010, Austria | |
Completed | El Palmar, 30120, Spain | |
Completed | Göteborg, 416 85, Sweden | |
Completed | Stockholm, 118 83, Sweden | |
Completed | Stockholm, 141 86, Sweden | |
Completed | Stockholm, 182 88, Sweden | |
Completed | Örebro, 701 85, Sweden | |
Completed | Falun, 791 82, Sweden | |
Completed | Umeå, 901 85, Sweden | |
Completed | Pisa, 56124, Italy | |
Completed | Graz, 8020, Austria | |
Completed | Graz, 8036, Austria | |
Withdrawn | Bodø, 8092, Norway | |
Withdrawn | Tromsø, 9038, Norway | |
Completed | Perugia, 06129, Italy | |
Completed | Detroit, 48201, United States | |
Completed | Detroit, 48202, United States | |
Completed | Innsbruck, 6020, Austria | |
Completed | Valencia, 46010, Spain | |
Completed | Valencia, 46026, Spain | |
Completed | Madrid, 28041, Spain | |
Completed | Barcelona, 08035, Spain | |
Completed | Toronto, M5B 1W8, Canada | |
Withdrawn | Victoria, V8R 4R2, Canada | |
Withdrawn | Vancouver, V5Z 1M9, Canada | |
Completed | Sherbrooke, J1H 5N4, Canada | |
Completed | Ottawa, K1Y 4W7, Canada | |
Withdrawn | St-Charles-Borromee, J6E 6J2, Canada | |
Completed | Montreal, H3T 1E2, Canada | |
Completed | Montreal, H1T 1C8, Canada | |
Withdrawn | Cambridge, N1R 6V6, Canada | |
Completed | Saint-Jean-sur-Richelieu, J3A 1C3, Canada | |
Withdrawn | Hamilton, L8L 2X2, Canada | |
Completed | Calgary, T2N 4Z6, Canada | |
Completed | Esbjerg, 6700, Denmark | |
Completed | Barcelona, 08003, Spain | |
Completed | Seoul, 05505, Korea, Republic Of | |
Completed | Seoul, 03080, Korea, Republic Of | |
Completed | Wonju, 26426, Korea, Republic Of | |
Completed | Petoria, South Africa | |
Completed | Tongaat, 4400, South Africa | |
Completed | Merebank, 4052, South Africa | |
Completed | Somerset West, 7130, South Africa | |
Completed | Worcester, 6850, South Africa | |
Completed | Pinelands, 7405, South Africa | |
Completed | Isipingo Rail, 4110, South Africa | |
Completed | Kuils River, 7580, South Africa | |
Completed | Cape Town, 7500, South Africa | |
Completed | Somerset West, 7130, South Africa | |
Completed | Zefat, 1311001, Israel | |
Completed | Ashkelon, 7830604, Israel | |
Completed | Petach Tikva, 4941492, Israel | |
Completed | Rehovot, 7610001, Israel | |
Completed | Hadera, 3810101, Israel | |
Completed | Tel Aviv, 64239, Israel | |
Completed | Afula, 1834111, Israel | |
Completed | Jerusalem, 9103102, Israel | |
Completed | Haifa, 3436212, Israel | |
Completed | Nahariya, 2210001, Israel | |
Completed | Kfar Saba, 4428164, Israel | |
Completed | Zerifin, 7030000, Israel | |
Withdrawn | Atlanta, 30308, United States | |
Withdrawn | San Francisco, 94143, United States | |
Completed | Macon, 31201, United States | |
Completed | Olot, 17800, Spain | |
Withdrawn | Liberec, 46063, Czechia | |
Withdrawn | Plzen - Bory, 305 99, Czechia | |
Completed | Praha 5, 150 30, Czechia | |
Withdrawn | New Orleans, 70112, United States | |
Completed | Majadahonda, 28222, Spain | |
Completed | Szekesfehervar, 8000, Hungary | |
Completed | Budapest, 1027, Hungary | |
Completed | Budapest, 1097, Hungary | |
Completed | Budapest, 1085, Hungary | |
Completed | Nagykanizsa, 8800, Hungary | |
Completed | Stade, 21682, Germany | |
Withdrawn | Philadelphia, 19107, United States | |
Withdrawn | Petoskey, 49770-2297, United States | |
Withdrawn | Valasske Mezirici, 757 42, Czechia | |
Completed | Ostrava, 728 80, Czechia | |
Completed | Jindrichuv Hradec, 377 01, Czechia | |
Completed | Baltimore, 21201, United States | |
Completed | Wroclaw, 50-981, Poland | |
Completed | Krakow, 31-121, Poland | |
Completed | Bydgoszcz, 85-681, Poland | |
Completed | Szczecin, 70-965, Poland | |
Completed | Gdansk, 80-952, Poland | |
Completed | Newark, 07103, United States | |
Completed | La Jolla, 92037, United States | |
Completed | GRONINGEN, 9700 RB, Netherlands | |
Completed | NIJMEGEN, 6525 GA, Netherlands | |
Completed | GRONINGEN, 9728 NT, Netherlands | |
Completed | VELDHOVEN, 5504 DB, Netherlands | |
Completed | AMSTERDAM, 1061 AE, Netherlands | |
Completed | ROTTERDAM, 3045 PM, Netherlands | |
Completed | DELFT, 2625 AD, Netherlands | |
Completed | HOOGEVEEN, 7909 AA, Netherlands | |
Completed | Prahran, 3004, Australia | |
Withdrawn | Herston, 4029, Australia | |
Completed | Adelaide, 5042, Australia | |
Completed | Concord, 2139, Australia | |
Withdrawn | Geelong, 3220, Australia | |
Completed | Porto, P-4200, Portugal | |
Completed | Lisboa, 1500-650, Portugal | |
Completed | Almada, 2801-951, Portugal | |
Completed | Lisboa, 1449-005, Portugal | |
Completed | Lisboa, 1649-035, Portugal | |
Completed | Faro, 8000-386, Portugal | |
Completed | Taipei, 11217, Taiwan | |
Completed | Taipei, 100, Taiwan | |
Completed | Taipei, Taiwan | |
Completed | Taizung, 402, Taiwan | |
Completed | Jacksonville, 32209, United States | |
Withdrawn | New Orleans, 70121, United States | |
Completed | Los Angeles, 90033, United States | |
Withdrawn | Hickory, 28601, United States | |
Completed | Warszawa, 04-628, Poland | |
Completed | Katowice, 40-635, Poland | |
Withdrawn | Warszawa, 02-005, Poland | |
Completed | Kielce, 25-736, Poland | |
Completed | Bialystok, 15-276, Poland | |
Completed | ZUTPHEN, 7207 AE, Netherlands | |
Completed | Ruse, 7002, Bulgaria | |
Completed | Varna, 9010, Bulgaria | |
Completed | Pazardzhik, 4400, Bulgaria | |
Completed | Sofia, 1309, Bulgaria | |
Completed | Sofia, 1431, Bulgaria | |
Completed | Sofia, 1233, Bulgaria | |
Completed | Quebec, G1V 4G5, Canada | |
Completed | DARLINGHURST, 2010, Australia | |
Completed | Burgas, 8018, Bulgaria | |
Completed | Nea Ionia / Athens, 14233, Greece | |
Completed | Larissa, 41100, Greece | |
Completed | Birmingham, 35294-2041, United States | |
Completed | Slany, 274 01, Czechia | |
Withdrawn | Brno, 63600, Czechia | |
Completed | NICE, 06200, France | |
Completed | Frankfurt, 60389, Germany | |
Withdrawn | Seoul, 06591, Korea, Republic Of | |
Completed | Seoul, 03722, Korea, Republic Of | |
Completed | New Taipei City, 220, Taiwan | |
Completed | Ankara, 06100, Turkey | |
Withdrawn | Mainz, 55131, Germany | |
Completed | Ankara, 06500, Turkey | |
Withdrawn | Izmir, 35100, Turkey | |
Completed | Izmir, 35100, Turkey | |
Completed | Ankara, Turkey | |
Completed | Antalya, 07003, Turkey | |
Completed | Fairfield, 45014, United States | |
Completed | Glostrup, 2600, Denmark | |
Completed | Montreal, H2W 1T8, Canada | |
Withdrawn | Ft. Lauderdale, 33308, United States | |
Completed | Limburg, 65549, Germany |
Primary Outcome
- Percentage of participants with a relative decrease in NT-proBNP of more than 30% from baseline to Day 90N-terminal pro-B type natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute and chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.date_rangeTime Frame:Baseline and Day 90
Secondary Outcome
- Number of Participants With Death due to any CauseDeath due to any cause include cardiovascular (CV) death and Non-CV death. Non-CV death was classified by 2 subcategories: non-malignant causes and malignant causes.date_rangeTime Frame:Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
- Number of Participants With Cardiovascular HospitalizationHospitalizations were defined as any unplanned admission to hospital, i.e. completion of hospital admission procedures and one overnight [i.e. date change] stay or until the death of subject occurred. Hospitalizations and deaths were classified by 2 primary categories: CV and non-CV. The pre-specified subcategories for CV hospitalizations were as follows: 1. Worsening heart failure, 2.Acute myocardial infarction, 3. Arrhythmia, 4.Transient ischemic attack and stroke, 5. Other CV hospitalizations.date_rangeTime Frame:Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
- Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF)Emergency presentations for WCHF were defined as newly developing signs and symptoms of WCHF after start of treatment with study drug, requiring an additional emergency presentation to hospital and IV treatment with diuretics and/or positive inotropic agents.date_rangeTime Frame:Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
- Ratio of BNP at specified visits to BNP at baselineB-type natriuretic peptide (BNP) levels in the blood are used for screening, diagnosis of acute chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.date_rangeTime Frame:Day 30, Day 60, Day 90, Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)
- Ratio of NT-proBNP at specified visits to NT-proBNP at baselineN-terminal pro-B type natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.date_rangeTime Frame:Day 30, Day 60, Day 90, Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)
- Change from Baseline in KCCQ questionnaire scores at specified visitsThe Kansas City Cardiomyopathy Questionnaire (KCCQ) was the leading health related quality of life measure for subjects with CHF. KCCQ was a 23 item questionnaire that independently measures the impact of subjects HF, or its treatment, on 7 distinct domains: self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Results from the total symptom summary score are presented. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. In the below table, categorical data represents change from baseline data at respective time points.date_rangeTime Frame:Baseline, Day 30 and Day 90
- Change from Baseline in EQ-5D-3L questionnaire scores at specified visitsEuroQol Group 5-Dimension, 3-Level (EQ-5D-3L): participant rated questionnaire to assess health-related quality of life. It consists of EQ-5D descriptive system and EQ-5D Visual Analog Scale (VAS). EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1), some problems (2), and extreme problems (3). For this population, the possible EQ-5D-3L index scores ranges from -0.11 (that is, 3 for all 5 dimensions) to 1.0 (that is, 1 for all 5 dimensions), where higher scores indicate a better health state.date_rangeTime Frame:Baseline, Day 30, Day 90, Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
6