| Outcome Measures: |
Primary: Percentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to Day 90, N-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., Baseline and Day 90 | Secondary: Number of Participants With Death Due to Any Cause, Death 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., Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)|Number of Participants With Cardiovascular Hospitalization, Hospitalizations 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., 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., 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 Baseline, B-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., 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 Baseline, N-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., 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 Visits, The 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., Baseline, Day 30 and Day 90|Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits, EuroQol 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., 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) | Other: Change From Baseline in Serum Potassium at Specified Visits, Baseline, Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)|Change From Baseline in Systolic Blood Pressure at Specified Visits, Baseline,Day 7,14,30,60,90,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 Diastolic Blood Pressure at Specified Visits, Baseline,Day 7,14,30,60,90,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 Heart Rate at Specified Visits, Baseline,Day 7,14,30,60,90,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)
|
| Locations: |
Birmingham, Alabama, 35294-2041, 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 4Z6, Canada|Ottawa, Ontario, K1Y 4W7, Canada|Toronto, Ontario, M5B 1W8, Canada|Montreal, Quebec, H1T 1C8, Canada|Montreal, Quebec, H2W 1T8, Canada|Montreal, Quebec, H3T 1E2, Canada|Saint-Jean-sur-Richelieu, Quebec, J3A 1C3, Canada|Sherbrooke, Quebec, J1H 5N4, Canada|Quebec, G1V 4G5, Canada|Jindrichuv Hradec, 377 01, Czechia|Ostrava, 728 80, Czechia|Praha 5, 150 30, Czechia|Slany, 274 01, 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, 1834111, Israel|Ashkelon, 7830604, Israel|Hadera, 3810101, Israel|Haifa, 3436212, Israel|Jerusalem, 9103102, Israel|Kfar Saba, 4428164, Israel|Nahariya, 2210001, Israel|Petach Tikva, 4941492, Israel|Rehovot, 7610001, Israel|Tel Aviv, 64239, Israel|Zefat, 1311001, Israel|Zerifin, 7030000, 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-44320, Lithuania|Kaunas, LT-47144, Lithuania|Kaunas, LT-50161, Lithuania|Klaipeda, 92288, Lithuania|Klaipeda, LT-92288, Lithuania|Vilnius, LT-08661, Lithuania|Amsterdam, 1061 AE, Netherlands|Delft, 2625 AD, Netherlands|Groningen, 9700 RB, Netherlands|Groningen, 9728 NT, Netherlands|Hoogeveen, 7909 AA, Netherlands|Nijmegen, 6525 GA, Netherlands|Rotterdam, 3045 PM, Netherlands|Veldhoven, 5504 DB, Netherlands|Zutphen, 7207 AE, Netherlands|Stavanger, 4011, Norway|Bialystok, 15-276, Poland|Bydgoszcz, 85-681, Poland|Gdansk, 80-952, Poland|Katowice, 40-635, Poland|Kielce, 25-736, Poland|Krakow, 31-121, Poland|Szczecin, 70-965, Poland|Warszawa, 04-628, Poland|Wroclaw, 50-981, Poland|Almada, 2801-951, Portugal|Faro, 8000-386, Portugal|Lisboa, 1449-005, Portugal|Lisboa, 1500-650, Portugal|Lisboa, 1649-035, Portugal|Porto, P-4200, 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 82, Sweden|Göteborg, 416 85, Sweden|Stockholm, 118 83, Sweden|Stockholm, 141 86, Sweden|Stockholm, 182 88, Sweden|Umeå, 901 85, Sweden|Örebro, 701 85, 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
|
