Study Description
This is a multicenter, randomized, placebo- and active-controlled, parallel-group,
24-week trial to investigate the efficacy, safety, and tolerability of XXB750 in
participants with HFrEF/HFmrEF. Eligible participants will be randomized to receive either subcutaneous (s.c.) XXB750 or
placebo; or sacubitril/valsartan for 16 weeks, and then followed-up for 8 weeks
Interventions
Placebo
Sacubitril/valsartan
XXB750 High Dose
XXB750 Low dose
XXB750 Medium Dose
Eligibility Criteria
Inclusion Criteria:
- Current symptom(s) of HF NYHA class II-III and LVEF < 50%
- Elevated NT-proBNP levels at screening.
- Receiving standard of care background HF therapy.
Exclusion Criteria:
- Current acute decompensated HF or hospitalization for HF within 3 months prior to
screening.
- Current symptomatic hypotension (for example dizziness/presyncope).
- K+ > 5.4 mmol/L at screening
- eGFR < 30 mL/min/1.73m2 at screening
Other protocol-specific criteria may apply.
Study Location
Novartis Investigative Site
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Pleven,5800,Bulgaria
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Sofia,1233,Bulgaria
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Plovdiv,4002,Bulgaria
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Blagoevgrad,270 0,Bulgaria
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Sofia,1510,Bulgaria
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Kyustendil,2500,Bulgaria
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Sofia,1709,Bulgaria
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Varna,9010,Bulgaria
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Stara Zagora,6000,Bulgaria
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Gabrovo,5300,Bulgaria
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Jinan,250012,China
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Guangzhou,Guangdong,510515,China
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Tianjin,Tianjin,300121,China
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Chengdu,Sichuan,610041,China
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Luoyang,Henan,471002,China
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Beijing,100730,China
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Hvidovre,2650,Denmark
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Roskilde,4000,Denmark
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Herlev,Dk 2730,Denmark
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Montpellier,34295,France
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Rouen,76031,France
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Toulouse 4,31054,France
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Kiel,24105,Germany
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Dresden,01307,Germany
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Berlin,13347,Germany
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Gladbeck,45968,Germany
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Koeln,51065,Germany
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Dresden,Sachsen,01099,Germany
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Ludwigshafen,67063,Germany
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Ludwigshafen,67067,Germany
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Essen,Nordrhein Westfalen,45355,Germany
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Frankfurt,60590,Germany
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Coburg,96450,Germany
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Stuttgart,70376,Germany
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Papenburg,26871,Germany
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Schwaebisch Hall,74523,Germany
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Frankfurt,60594,Germany
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Leipzig,04289,Germany
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Berlin,10787,Germany
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Messina,ME,98125,Italy
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Roma,RM,00161,Italy
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Milano,MI,20138,Italy
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Ancona,AN,60128,Italy
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Brescia,BS,25123,Italy
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Pordenone,PN,33170,Italy
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Reggio Emilia,RE,42123,Italy
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Bergamo,BG,24127,Italy
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Trieste,TS,34149,Italy
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Roma,RM,00133,Italy
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Cona,FE,44100,Italy
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Pisa,PI,56126,Italy
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Itabashi-ku,Tokyo,173-8610,Japan
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Koriyama,Fukushima,963-8501,Japan
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Maebashi city,Gunma,371 8511,Japan
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Sagamihara,Kanagawa,252-0375,Japan
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Hachioji-city,Tokyo,192-0918,Japan
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Kawaguchi-city,Saitama,333-0842,Japan
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Kawasaki-city,Kanagawa,216-8511,Japan
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Matsumoto,Nagano,390-8621,Japan
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Groningen,Netherlands
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Leeuwarden,8934 ad,Netherlands
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Lisboa,1500 650,Portugal
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Vila Nova De Gaia,4434 502,Portugal
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Lisboa,1495 005,Portugal
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Kosice,040 01,Slovakia
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Nitra,949 01,Slovakia
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Bardejov,085 01,Slovakia
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Presov,080 01,Slovakia
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Nove Zamky,940 01,Slovakia
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Martin,036 01,Slovakia
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Svidnik,089 01,Slovakia
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Utrera,Andalucia,41710,Spain
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Madrid,28041,Spain
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Valencia,Comunidad Valenciana,46010,Spain
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Alicante,03700,Spain
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Madrid,28222,Spain
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Valencia,46026,Spain
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El Palmar,Murcia,30120,Spain
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Las Palmas de Gran Canaria,35010,Spain
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Malaga,Andalucia,29010,Spain
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Santiago De Compostela,Galicia,15706,Spain
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Madrid,28034,Spain
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Huelva,Andalucia,21005,Spain
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Madrid,28040,Spain
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Sevilla,Andalucia,41014,Spain
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Taichung,40447,Taiwan
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Tainan,71004,Taiwan
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Taipei,11217,Taiwan
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Kaohsiung,80756,Taiwan
SEC Clinical Research Research
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Dothan,Alabama,36305,United States
NexGen Research
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Lima,Ohio,45805,United States
Baylor University Medical Center Facility
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Dallas,Texas,75246,United States
Jacksonville Ctr for Clin Rea Main Centre
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Jacksonville,Florida,32216,United States
Washington Univ School of Medicine
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Saint Louis,Missouri,63110,United States
Fairview Health Services St Johns
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Saint Paul,Minnesota,55103,United States
St Johns Center Research
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Ponte Vedra,Florida,32801,United States
Cardiology Partners Clinical Research Institute
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Wellington,Florida,33449,United States
John Peter Smith Hospital
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Fort Worth,Texas,76104,United States
Grace Research .
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Marshall,Texas,75670,United States
St Louis Heart and Vascular .
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Saint Louis,Missouri,63136,United States
Clinical Research of Rock Hill
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Rock Hill,South Carolina,29732,United States
Laurelton Heart Specialist PC Research
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Rosedale,New York,11422,United States
Grace Research Llc .
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Shreveport,Louisiana,71101,United States
Tennessee Center For Clinical Trials .
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Tullahoma,Tennessee,37388,United States
Cypress Heart and Vascular Center
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Cypress,Texas,77429,United States
Memorial Care Health System Memorialcare Long Beach
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Long Beach,California,90806,United States
American Clinical Trials
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Acworth,Georgia,30101,United States
Heart Center Research Llc .
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Huntsville,Alabama,35801,United States
The Research Group Lewis Hargett Circle
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Lexington,Kentucky,40503,United States
Dominion Medical Associates
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Richmond,Virginia,23219,United States
Prisma Health Research
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Columbia,South Carolina,29203,United States
Miami Clinical Research .
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Miami,Florida,33155,United States
Anderson Medical Research Main Center
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Fort Washington,Maryland,20744,United States
Heart Clinic of Hammond .
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Hammond,Louisiana,70403,United States
Troy Internal Medicine Research .
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Troy,Michigan,48098,United States
Ormond Beach Clinical Research
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Ormond Beach,Florida,32174,United States
East Coast Inst for Research LLC
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Saint Augustine,Florida,32086,United States
Revival Research Institute .
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Troy,Michigan,48084,United States
Nature Coast Clinical Research LLC
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Inverness,Florida,34452,United States
Aultman Hospital
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Canton,Ohio,44710,United States
Inpatient Research Clinical LLC
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Miami Lakes,Florida,33014,United States
Universal Research Group LLC Suite 202
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Tacoma,Washington,98405,United States
Pima Heart And Vascular Clin Rch Research
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Tucson,Arizona,85704,United States
East Coast Institute for Research East Coast Inst for Res ECIR
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Jacksonville,Florida,32223,United States
Worldwide Contacts
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