Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction

February 19, 2019 updated by: Novartis Pharmaceuticals

A Multicenter Study to Evaluate Safety and Tolerability in Patients With Chronic Heart Failure and Reduced Ejection Fraction From PARADIGM-HF Receiving Open Label LCZ696

The purpose of this study was to collect safety and tolerability data on LCZ696 in eligible PARADIGM-HF patients who received open-label investigational drug. The parent PARADIGM-HF (NCT01035255) trial was terminated early due to compelling efficacy of LCZ696 in patients with heart failure with reduced ejection fraction (HFrEF) after the final pre-specified interim analysis in March 2014.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1980

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina, X5016KET
        • Novartis Investigative Site
      • Cordoba, Argentina, 5000
        • Novartis Investigative Site
      • Cordoba, Argentina, X5000AAX
        • Novartis Investigative Site
      • Corrientes, Argentina, W3400CLH
        • Novartis Investigative Site
      • Formosa, Argentina, P3600
        • Novartis Investigative Site
      • Formosa, Argentina, P3634XAR
        • Novartis Investigative Site
      • Mendoza, Argentina, M5500CHC
        • Novartis Investigative Site
      • San Luis, Argentina, D5702JRS
        • Novartis Investigative Site
      • Santa Fe, Argentina, S3000FWO
        • Novartis Investigative Site
      • Santa Fe, Argentina, S3000EOZ
        • Novartis Investigative Site
      • Santiago del Estero, Argentina, G4200AQK
        • Novartis Investigative Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1221ADC
        • Novartis Investigative Site
      • Ciudad Autonoma de Bs As, Buenos Aires, Argentina, C1119ACN
        • Novartis Investigative Site
      • Mar del Plata, Buenos Aires, Argentina, B7600FZN
        • Novartis Investigative Site
      • Quilmes, Buenos Aires, Argentina, B1878DVB
        • Novartis Investigative Site
    • Capital Federal
      • Caba, Capital Federal, Argentina, C1179AAB
        • Novartis Investigative Site
    • Jujuy
      • San Salvador de Jujuy, Jujuy, Argentina, Y4600ABF
        • Novartis Investigative Site
    • Provincia De Salta
      • Ciudad de Salta, Provincia De Salta, Argentina, A4406BPF
        • Novartis Investigative Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000AII
        • Novartis Investigative Site
      • Rosario, Santa Fe, Argentina, 2000
        • Novartis Investigative Site
      • Rosario, Santa Fe, Argentina, S2000QID
        • Novartis Investigative Site
  • Belgium
      • Brasschaat, Belgium, 2930
        • Novartis Investigative Site
      • Gent, Belgium, 9000
        • Novartis Investigative Site
      • La Louviere, Belgium, 7100
        • Novartis Investigative Site
      • Leuven, Belgium, 3000
        • Novartis Investigative Site
      • Ronse, Belgium, 9600
        • Novartis Investigative Site
  • Brazil
    • BA
      • Salvador, BA, Brazil, 41810-010
        • Novartis Investigative Site
    • DF
      • Brasilia, DF, Brazil, 70390-903
        • Novartis Investigative Site
    • GO
      • Goiania, GO, Brazil, 74605 050
        • Novartis Investigative Site
      • Goiania, GO, Brazil, 74223-130
        • Novartis Investigative Site
      • Goiania, GO, Brazil, 74823-470
        • Novartis Investigative Site
    • MA
      • Sao Luis, MA, Brazil, 65020-070
        • Novartis Investigative Site
    • MG
      • Belo Horizonte, MG, Brazil, 30150-221
        • Novartis Investigative Site
      • Belo Horizonte, MG, Brazil, 20180-090
        • Novartis Investigative Site
    • Mg-cep
      • Uberlandia, Mg-cep, Brazil, 38411-186
        • Novartis Investigative Site
    • PA
      • Belem, PA, Brazil, 66087-660
        • Novartis Investigative Site
    • PE
      • Recife, PE, Brazil, 52051-380
        • Novartis Investigative Site
    • RJ
      • Rio de Janeiro, RJ, Brazil, 22280-020
        • Novartis Investigative Site
    • RS
      • Porto Alegre, RS, Brazil, 90880-480
        • Novartis Investigative Site
    • SP
      • Marilia, SP, Brazil, 17515-000
        • Novartis Investigative Site
      • Ribeirao Preto, SP, Brazil, 14055-370
        • Novartis Investigative Site
      • Santo Andre, SP, Brazil, 09190-615
        • Novartis Investigative Site
      • Sao Jose do Rio Preto, SP, Brazil, 15015-750
        • Novartis Investigative Site
      • Sao Paulo, SP, Brazil, 05403-000
        • Novartis Investigative Site
      • Sao Paulo, SP, Brazil, 01323 000
        • Novartis Investigative Site
      • Votuporanga, SP, Brazil, 15500-003
        • Novartis Investigative Site
  • Bulgaria
      • Haskovo, Bulgaria, 6300
        • Novartis Investigative Site
      • Pleven, Bulgaria, 5800
        • Novartis Investigative Site
      • Plovdiv, Bulgaria, 4000
        • Novartis Investigative Site
      • Shumen, Bulgaria, 9700
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1527
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1309
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1431
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1233
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1606
        • Novartis Investigative Site
      • Varna, Bulgaria, 9010
        • Novartis Investigative Site
  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8R4R2
        • Novartis Investigative Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Novartis Investigative Site
    • Ontario
      • Kitchener, Ontario, Canada, N2M 5N4
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M5B 1W8
        • Novartis Investigative Site
      • Weston, Ontario, Canada, M9N 1W4
        • Novartis Investigative Site
    • Quebec
      • Levis, Quebec, Canada, G6V 4Z5
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H3T 1E2
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H3G 1A4
        • Novartis Investigative Site
      • St-Georges Beauce, Quebec, Canada, G5Y 4T8
        • Novartis Investigative Site
  • Chile
    • Araucania
      • Temuco, Araucania, Chile, 4780000
        • Novartis Investigative Site
  • Czechia
      • Kolin, Czechia, 280 20
        • Novartis Investigative Site
      • Prague 5, Czechia, 150 30
        • Novartis Investigative Site
      • Praha, Czechia, 12808
        • Novartis Investigative Site
      • Uherske Hradiste, Czechia, 68601
        • Novartis Investigative Site
    • CZE
      • Bilovec, CZE, Czechia, 743 01
        • Novartis Investigative Site
    • Czech Republic
      • Beroun, Czech Republic, Czechia, 266 01
        • Novartis Investigative Site
      • Brandys nad Labem, Czech Republic, Czechia, 250 01
        • Novartis Investigative Site
      • Liberec V Kristianova, Czech Republic, Czechia, 460 05
        • Novartis Investigative Site
      • Olomouc, Czech Republic, Czechia, 779 00
        • Novartis Investigative Site
      • Prague 10, Vrsovice, Czech Republic, Czechia, 10100
        • Novartis Investigative Site
      • Trebic, Czech Republic, Czechia, 674 01
        • Novartis Investigative Site
  • Denmark
      • Copenhagen, Denmark, DK-2100
        • Novartis Investigative Site
      • Esbjerg, Denmark, DK-6700
        • Novartis Investigative Site
      • Hellerup, Denmark, DK-2900
        • Novartis Investigative Site
      • Randers, Denmark, 8930
        • Novartis Investigative Site
      • Svendborg, Denmark, 5700
        • Novartis Investigative Site
      • Vejle, Denmark, 7100
        • Novartis Investigative Site
      • Viborg, Denmark, DK-8800
        • Novartis Investigative Site
  • Estonia
      • Tallinn, Estonia, 13419
        • Novartis Investigative Site
      • Tartu, Estonia, 50410
        • Novartis Investigative Site
  • Finland
      • Tampere, Finland, 33520
        • Novartis Investigative Site
  • France
      • Paris, France, 75015
        • Novartis Investigative Site
    • Herault
      • Montpellier cedex 5, Herault, France, 34059
        • Novartis Investigative Site
  • Germany
      • Bad Homburg, Germany, 61348
        • Novartis Investigative Site
      • Bad Krozingen, Germany, 79189
        • Novartis Investigative Site
      • Berlin, Germany, 13405
        • Novartis Investigative Site
      • Berlin, Germany, 10369
        • Novartis Investigative Site
      • Berlin-Buch, Germany, 13125
        • Novartis Investigative Site
      • Dessau-Roßlau, Germany, 06846
        • Novartis Investigative Site
      • Dresden, Germany, 01307
        • Novartis Investigative Site
      • Dresden, Germany, 01309
        • Novartis Investigative Site
      • Elsterwerda, Germany, 04910
        • Novartis Investigative Site
      • Frankfurt, Germany, 65929
        • Novartis Investigative Site
      • Frankfurt, Germany, 60488
        • Novartis Investigative Site
      • Hamburg, Germany, 22291
        • Novartis Investigative Site
      • Hamburg, Germany, 22765
        • Novartis Investigative Site
      • Huy / OT Anderbeck, Germany, 38836
        • Novartis Investigative Site
      • Ingelheim, Germany, 55218
        • Novartis Investigative Site
      • Kelkheim, Germany, 65779
        • Novartis Investigative Site
      • Koethen, Germany, 06366
        • Novartis Investigative Site
      • Künzelsau, Germany, 74653
        • Novartis Investigative Site
      • Leipzig, Germany, 04109
        • Novartis Investigative Site
      • Leipzig, Germany, 04129
        • Novartis Investigative Site
      • Leipzig, Germany, 04315
        • Novartis Investigative Site
      • Loehne, Germany, 32584
        • Novartis Investigative Site
      • Muehldorf, Germany, 84453
        • Novartis Investigative Site
      • Muehlheim An Der Ruhr, Germany, 45468
        • Novartis Investigative Site
      • Offenbach, Germany, 63073
        • Novartis Investigative Site
      • Wermsdorf, Germany, 04779
        • Novartis Investigative Site
      • Wetzlar-Naunheim, Germany, 35584
        • Novartis Investigative Site
      • Weyhe, Germany, 28844
        • Novartis Investigative Site
    • Sachsen
      • Dresden, Sachsen, Germany, 01099
        • Novartis Investigative Site
  • Guatemala
      • Guatemala City, Guatemala, 01010
        • Novartis Investigative Site
      • Guatemala City, Guatemala, 01015
        • Novartis Investigative Site
    • Ciudad
      • Guatemala, Ciudad, Guatemala, 01010
        • Novartis Investigative Site
  • Hong Kong
      • Hong Kong, Hong Kong, HONG KONG
        • Novartis Investigative Site
      • Hong Kong SAR, Hong Kong
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, 1125
        • Novartis Investigative Site
      • Budapest, Hungary, 1145
        • Novartis Investigative Site
      • Budapest, Hungary, 1134
        • Novartis Investigative Site
      • Budapest, Hungary, 1122
        • Novartis Investigative Site
      • Budapest, Hungary, 1096
        • Novartis Investigative Site
      • Debrecen, Hungary, 4032
        • Novartis Investigative Site
      • Nyiregyháza, Hungary, 4400
        • Novartis Investigative Site
      • Szekesfehervar, Hungary, H-8000
        • Novartis Investigative Site
      • Szekszard, Hungary, 7100
        • Novartis Investigative Site
      • Zalaegerszeg, Hungary, 8900
        • Novartis Investigative Site
  • India
      • Indore, India, 452014
        • Novartis Investigative Site
    • Andhra Pradesh
      • Guntur, Andhra Pradesh, India, 522001
        • Novartis Investigative Site
    • Delhi
      • Dehli, Delhi, India, 110080
        • Novartis Investigative Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380 051
        • Novartis Investigative Site
      • Ahmedabad, Gujarat, India, 380054
        • Novartis Investigative Site
      • Anand, Gujarat, India, 388325
        • Novartis Investigative Site
      • Surat, Gujarat, India, 395 002
        • Novartis Investigative Site
    • Gujrat
      • Surat, Gujrat, India, 395002
        • Novartis Investigative Site
      • Vadodara, Gujrat, India, 390015
        • Novartis Investigative Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Novartis Investigative Site
      • Nagpur, Maharashtra, India, 440010
        • Novartis Investigative Site
      • Nagpur, Maharashtra, India, 400012
        • Novartis Investigative Site
      • Nashik, Maharashtra, India, 422005
        • Novartis Investigative Site
      • Nashik, Maharashtra, India, 422 005
        • Novartis Investigative Site
      • Nashik, Maharashtra, India, 422002
        • Novartis Investigative Site
      • Pune, Maharashtra, India, 411 011
        • Novartis Investigative Site
      • Pune, Maharashtra, India, 411011
        • Novartis Investigative Site
    • Punjab
      • Ludhiana, Punjab, India, 141002
        • Novartis Investigative Site
    • Rajasthan
      • Bikaner, Rajasthan, India, 334003
        • Novartis Investigative Site
    • Telangana
      • Hyderabad, Telangana, India, 500 063
        • Novartis Investigative Site
  • Israel
      • Ashkelon, Israel, 78278
        • Novartis Investigative Site
      • Hadera, Israel, 38100
        • Novartis Investigative Site
      • Haifa, Israel, 3525408
        • Novartis Investigative Site
      • Haifa, Israel, 3436212
        • Novartis Investigative Site
      • Jerusalem, Israel, 91120
        • Novartis Investigative Site
      • Petach Tikva, Israel, 49100
        • Novartis Investigative Site
      • Rehovot, Israel, 76100
        • Novartis Investigative Site
      • Safed, Israel, 13100
        • Novartis Investigative Site
  • Italy
    • AO
      • Aosta, AO, Italy, 11100
        • Novartis Investigative Site
    • AR
      • Cortona, AR, Italy, 52044
        • Novartis Investigative Site
    • BG
      • Bergamo, BG, Italy, 24127
        • Novartis Investigative Site
      • Treviglio, BG, Italy, 24047
        • Novartis Investigative Site
    • CS
      • Cosenza, CS, Italy, 87100
        • Novartis Investigative Site
    • FE
      • Cona, FE, Italy, 44100
        • Novartis Investigative Site
    • GE
      • Genova, GE, Italy, 16132
        • Novartis Investigative Site
    • IS
      • Pozzilli, IS, Italy, 86077
        • Novartis Investigative Site
    • LU
      • Lido di Camaiore, LU, Italy, 55041
        • Novartis Investigative Site
    • ME
      • Milazzo, ME, Italy, 98057
        • Novartis Investigative Site
    • PI
      • Pisa, PI, Italy, 56126
        • Novartis Investigative Site
    • PV
      • Pavia, PV, Italy, 27100
        • Novartis Investigative Site
    • Point
      • Pescia, Point, Italy, 51017
        • Novartis Investigative Site
    • RM
      • Ariccia, RM, Italy, 00041
        • Novartis Investigative Site
      • Roma, RM, Italy, 00163
        • Novartis Investigative Site
    • SA
      • Salerno, SA, Italy, 84131
        • Novartis Investigative Site
    • SS
      • Sassari, SS, Italy, 07100
        • Novartis Investigative Site
  • Korea, Republic of
      • Daegu, Korea, Republic of, 705703
        • Novartis Investigative Site
      • Daegu, Korea, Republic of, 705 718
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 05355
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 156-707
        • Novartis Investigative Site
    • Gangwon-Do
      • Wonju, Gangwon-Do, Korea, Republic of, 26426
        • Novartis Investigative Site
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Korea, Republic of, 16499
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, Korea, Republic of, 05505
        • Novartis Investigative Site
    • Seocho-gu
      • Seoul, Seocho-gu, Korea, Republic of, 06591
        • Novartis Investigative Site
  • Latvia
      • Daugavpils, Latvia, LV-5417
        • Novartis Investigative Site
      • Ventspils, Latvia, LV-3601
        • Novartis Investigative Site
  • Lithuania
      • Kaunas, Lithuania, LT-49387
        • Novartis Investigative Site
      • Kedainiai, Lithuania, LT-57164
        • Novartis Investigative Site
      • Vilnius, Lithuania, LT-08661
        • Novartis Investigative Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Novartis Investigative Site
      • Kuala Lumpur, Malaysia, 50400
        • Novartis Investigative Site
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Novartis Investigative Site
      • San Luis Potosi, Mexico, 78200
        • Novartis Investigative Site
      • San Luis Potosí, Mexico, 78200
        • Novartis Investigative Site
    • Queretaro
      • San Juan del Rio, Queretaro, Mexico, 76800
        • Novartis Investigative Site
  • Netherlands
      • Amersfoort, Netherlands, 3813 TZ
        • Novartis Investigative Site
      • Arnhem, Netherlands, 6815 AD
        • Novartis Investigative Site
      • Blaricum, Netherlands, 1261 AN
        • Novartis Investigative Site
      • Delft, Netherlands, 2625 AD
        • Novartis Investigative Site
      • Den Bosch, Netherlands, 5223 GZ
        • Novartis Investigative Site
      • Ede, Netherlands, 6716 RP
        • Novartis Investigative Site
      • Gorinchem, Netherlands, 4204 AA
        • Novartis Investigative Site
      • Hardenberg, Netherlands, 7770 AA
        • Novartis Investigative Site
      • Harderwijk, Netherlands, 3840 AC
        • Novartis Investigative Site
      • Heerenveen, Netherlands, 8441 PW
        • Novartis Investigative Site
      • Hengelo, Netherlands, 7555 DL
        • Novartis Investigative Site
      • Sneek, Netherlands, 8601 ZK
        • Novartis Investigative Site
      • Tilburg, Netherlands, 5022 GC
        • Novartis Investigative Site
      • Veldhoven, Netherlands, 5504 DB
        • Novartis Investigative Site
    • CK
      • Breda, CK, Netherlands, 4818
        • Novartis Investigative Site
  • Panama
      • Panama City, Panama
        • Novartis Investigative Site
      • Panama City, Panama, 0816-02351
        • Novartis Investigative Site
  • Peru
      • Arequipa, Peru, Areq01
        • Novartis Investigative Site
    • Lima
      • Bellavista, Lima, Peru, CALLAO 02
        • Novartis Investigative Site
      • Jesus Maria, Lima, Peru, 11
        • Novartis Investigative Site
      • La Molina, Lima, Peru, 12
        • Novartis Investigative Site
      • San Borja, Lima, Peru, 41
        • Novartis Investigative Site
      • San Isidro, Lima, Peru, 27
        • Novartis Investigative Site
      • San Miguel, Lima, Peru, 32
        • Novartis Investigative Site
  • Philippines
      • Pasig City, Philippines, 1605
        • Novartis Investigative Site
      • Quezon City, Philippines, 1102
        • Novartis Investigative Site
      • Quezon City, Philippines, 1100
        • Novartis Investigative Site
    • Batangas
      • Lipa City, Batangas, Philippines, 4217
        • Novartis Investigative Site
    • Manila
      • Quezon City, Manila, Philippines, 1100
        • Novartis Investigative Site
  • Poland
      • Gdynia, Poland, 81-472
        • Novartis Investigative Site
      • Gdynia, Poland, 81-548
        • Novartis Investigative Site
      • Lublin, Poland, 20-857
        • Novartis Investigative Site
  • Portugal
      • Covilha, Portugal, 6200-251
        • Novartis Investigative Site
      • Guimaraes, Portugal, 4835-044
        • Novartis Investigative Site
      • Lisboa, Portugal, 1449-005
        • Novartis Investigative Site
      • Portalegre, Portugal, 7300-853
        • Novartis Investigative Site
      • Porto, Portugal, 4200-319
        • Novartis Investigative Site
      • Setubal, Portugal, 2910-446
        • Novartis Investigative Site
    • Portuigal
      • Vila Real, Portuigal, Portugal, 5000-508
        • Novartis Investigative Site
  • Romania
      • Bucharest, Romania, 050098
        • Novartis Investigative Site
      • Bucuresti, Romania, 011728
        • Novartis Investigative Site
      • Craiova, Romania, 200642
        • Novartis Investigative Site
      • Deva, Romania, 330084
        • Novartis Investigative Site
      • Timisoara, Romania, 300736
        • Novartis Investigative Site
      • Timisoara, Romania, 300041
        • Novartis Investigative Site
    • District 1
      • Bucharest, District 1, Romania
        • Novartis Investigative Site
      • Bucuresti, District 1, Romania, 014461
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    • Jud. Dolj
      • Craiova, Jud. Dolj, Romania, 200497
        • Novartis Investigative Site
    • Timis
      • Timisoara, Timis, Romania, 300362
        • Novartis Investigative Site
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620137
        • Novartis Investigative Site
      • Ivanovo, Russian Federation, 153012
        • Novartis Investigative Site
      • Kazan, Russian Federation, 420012
        • Novartis Investigative Site
      • Kemerovo, Russian Federation, 650002
        • Novartis Investigative Site
      • Kirov, Russian Federation, 610027
        • Novartis Investigative Site
      • Krasnodar, Russian Federation, 350012
        • Novartis Investigative Site
      • Moscow, Russian Federation, 117198
        • Novartis Investigative Site
      • Moscow, Russian Federation, 127473
        • Novartis Investigative Site
      • Moscow, Russian Federation, 115516
        • Novartis Investigative Site
      • Moscow, Russian Federation, 121552
        • Novartis Investigative Site
      • Moscow, Russian Federation, 121309
        • Novartis Investigative Site
      • Moscow, Russian Federation, 101990
        • Novartis Investigative Site
      • Moscow, Russian Federation, 115280
        • Novartis Investigative Site
      • Moscow, Russian Federation, 119881
        • Novartis Investigative Site
      • N. Novgorod, Russian Federation, 603003
        • Novartis Investigative Site
      • N.Novgorod, Russian Federation, 603005
        • Novartis Investigative Site
      • Nizhnii Novgorod, Russian Federation, 603126
        • Novartis Investigative Site
      • Novosibirsk-117, Russian Federation, 630117
        • Novartis Investigative Site
      • Orenburg, Russian Federation, 460000
        • Novartis Investigative Site
      • Orenburg, Russian Federation, 460040
        • Novartis Investigative Site
      • Perm, Russian Federation, 614097
        • Novartis Investigative Site
      • Rostov-on-Don, Russian Federation, 344022
        • Novartis Investigative Site
      • S-Petersburg, Russian Federation, 194354
        • Novartis Investigative Site
      • Saint Petersburg, Russian Federation, 197022
        • Novartis Investigative Site
      • Saint Petersburg, Russian Federation, 197341
        • Novartis Investigative Site
      • Saint Petersburg, Russian Federation, 199106
        • Novartis Investigative Site
      • Saint-Petersburg, Russian Federation, 194044
        • Novartis Investigative Site
      • Saint-Petersburg, Russian Federation, 191144
        • Novartis Investigative Site
      • Saratov, Russian Federation, 410012
        • Novartis Investigative Site
      • Smolensk, Russian Federation, 214018
        • Novartis Investigative Site
      • St-Petersburg, Russian Federation, 194017
        • Novartis Investigative Site
      • St-Petersburg, Russian Federation, 194295
        • Novartis Investigative Site
      • St-Petersburg, Russian Federation, 196084
        • Novartis Investigative Site
      • Tula, Russian Federation, 300053
        • Novartis Investigative Site
      • Vladimir, Russian Federation, 600020
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 308433
        • Novartis Investigative Site
      • Singapore, Singapore, 169609
        • Novartis Investigative Site
  • Slovakia
      • Bratislava, Slovakia, 821 07
        • Novartis Investigative Site
      • Bratislava, Slovakia, 842 31
        • Novartis Investigative Site
      • Bratislava, Slovakia, 851 07
        • Novartis Investigative Site
      • Kosice, Slovakia, 040 01
        • Novartis Investigative Site
      • Lucenec, Slovakia, 984 01
        • Novartis Investigative Site
      • Martin, Slovakia, 036 01
        • Novartis Investigative Site
    • Slovak Republic
      • Brezno, Slovak Republic, Slovakia, 977 42
        • Novartis Investigative Site
      • Kosice, Slovak Republic, Slovakia, 040 22
        • Novartis Investigative Site
      • Levice, Slovak Republic, Slovakia, 93401
        • Novartis Investigative Site
      • Presov, Slovak Republic, Slovakia, 08001
        • Novartis Investigative Site
      • Svidnik, Slovak Republic, Slovakia, 08901
        • Novartis Investigative Site
  • South Africa
      • Alberton, South Africa, 1449
        • Novartis Investigative Site
      • Bloemfontein, South Africa, 9301
        • Novartis Investigative Site
      • Cape Town, South Africa, 7505
        • Novartis Investigative Site
      • Cape Town, South Africa, 7405
        • Novartis Investigative Site
      • Durban, South Africa, 4110
        • Novartis Investigative Site
      • Johannesburg, South Africa, 2193
        • Novartis Investigative Site
      • Kempton Park, South Africa, 1620
        • Novartis Investigative Site
      • Pretoria, South Africa, 0184
        • Novartis Investigative Site
      • Pretoria, South Africa, 0121
        • Novartis Investigative Site
      • Worcester, South Africa, 6850
        • Novartis Investigative Site
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Novartis Investigative Site
    • Gauteng
      • Soweto, Gauteng, South Africa, 2013
        • Novartis Investigative Site
    • Kwa-Zulu Natal
      • Durban, Kwa-Zulu Natal, South Africa, 4052
        • Novartis Investigative Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7405
        • Novartis Investigative Site
  • Spain
      • Madrid, Spain, 28007
        • Novartis Investigative Site
      • Madrid, Spain, 28222
        • Novartis Investigative Site
    • Andalucia
      • Malaga, Andalucia, Spain, 29010
        • Novartis Investigative Site
      • Marbella, Andalucia, Spain, 29600
        • Novartis Investigative Site
      • Sevilla, Andalucia, Spain, 41014
        • Novartis Investigative Site
    • Cataluna
      • Sant Joan Despi, Cataluna, Spain, 08970
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spain, 08035
        • Novartis Investigative Site
      • Barcelona, Catalunya, Spain, 08003
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46010
        • Novartis Investigative Site
      • Valencia, Comunidad Valenciana, Spain, 46015
        • Novartis Investigative Site
    • Galicia
      • A Coruna, Galicia, Spain, 15006
        • Novartis Investigative Site
      • La Coruna, Galicia, Spain, 15006
        • Novartis Investigative Site
      • Santiago de Compostela, Galicia, Spain, 15706
        • Novartis Investigative Site
      • Vigo, Galicia, Spain, 36211
        • Novartis Investigative Site
    • Madrid
      • Alcala de Henares, Madrid, Spain, 28805
        • Novartis Investigative Site
      • Mostoles, Madrid, Spain, 28935
        • Novartis Investigative Site
  • Sweden
      • Goteborg, Sweden, 416 85
        • Novartis Investigative Site
      • Göteborg, Sweden, 416 85
        • Novartis Investigative Site
      • Karlshamn, Sweden, 37480
        • Novartis Investigative Site
      • Motala, Sweden, 59185
        • Novartis Investigative Site
    • SE
      • Stockholm, SE, Sweden, 141 86
        • Novartis Investigative Site
  • Taiwan
      • Changhua, Taiwan, 50006
        • Novartis Investigative Site
      • Kaohsiung, Taiwan, 82445
        • Novartis Investigative Site
      • Taichung, Taiwan, 40447
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Novartis Investigative Site
      • Taipei, Taiwan, 11217
        • Novartis Investigative Site
      • Taipei, Taiwan, 114
        • Novartis Investigative Site
      • Yilan, Taiwan, 26058
        • Novartis Investigative Site
  • Thailand
      • Muang, Thailand, 12120
        • Novartis Investigative Site
    • Nonthaburi
      • Taladkwan, Nonthaburi, Thailand, 11000
        • Novartis Investigative Site
    • THA
      • Khon Kaen, THA, Thailand, 40002
        • Novartis Investigative Site
  • Turkey
      • Istanbul, Turkey, 34093
        • Novartis Investigative Site
      • Istanbul, Turkey, 34304
        • Novartis Investigative Site
      • Izmir, Turkey, 35040
        • Novartis Investigative Site
      • Izmir, Turkey, 35340
        • Novartis Investigative Site
      • Kocaeli, Turkey, 41380
        • Novartis Investigative Site
      • Sivas, Turkey, 58140
        • Novartis Investigative Site
  • United Kingdom
      • Cheshire, United Kingdom, CW1 4QJ
        • Novartis Investigative Site
      • Coventry, United Kingdom, CV2 2DX
        • Novartis Investigative Site
      • Exeter, United Kingdom, EX2 5AX
        • Novartis Investigative Site
      • Kent, United Kingdom, DA2 8DA
        • Novartis Investigative Site
      • Manchester, United Kingdom, M13 9WL
        • Novartis Investigative Site
      • Milton Keynes, United Kingdom, MK6 5LD
        • Novartis Investigative Site
      • Newport, United Kingdom, NP20 2UB
        • Novartis Investigative Site
      • Newport, United Kingdom, P030 5TG
        • Novartis Investigative Site
      • Norwich, United Kingdom, NR4 7UY
        • Novartis Investigative Site
      • Poole, United Kingdom, BH15 2JB
        • Novartis Investigative Site
      • Rotherham, United Kingdom, S60 2OD
        • Novartis Investigative Site
      • Worcester, United Kingdom, WR5 1DD
        • Novartis Investigative Site
    • County Durham
      • Durham, County Durham, United Kingdom, DH1 5TW
        • Novartis Investigative Site
    • Dorset
      • Dorchester, Dorset, United Kingdom, DT1 2JY
        • Novartis Investigative Site
    • Hampshire
      • Basingstoke, Hampshire, United Kingdom, RG24 9NA
        • Novartis Investigative Site
      • Portsmouth, Hampshire, United Kingdom, PO6 3LY
        • Novartis Investigative Site
    • Invernesshire
      • Inverness, Invernesshire, United Kingdom, IV2 3RE
        • Novartis Investigative Site
    • Lancashire
      • Oldham, Lancashire, United Kingdom, OL1 2JH
        • Novartis Investigative Site
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE2 7LX
        • Novartis Investigative Site
    • Northern Ireland
      • Craigavon, Northern Ireland, United Kingdom, BT63 5QQ
        • Novartis Investigative Site
    • Perthshire
      • Dundee, Perthshire, United Kingdom, DD1 9SY
        • Novartis Investigative Site
    • Somerset
      • Taunton, Somerset, United Kingdom, TA1 5DA
        • Novartis Investigative Site
      • Yeovil, Somerset, United Kingdom, BA21 4AT
        • Novartis Investigative Site
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2JF
        • Novartis Investigative Site
    • Surrey
      • Redhill, Surrey, United Kingdom, RH1 5RH
        • Novartis Investigative Site
    • Tyne And Wear
      • South Shields, Tyne And Wear, United Kingdom, NE34 0PL
        • Novartis Investigative Site
      • Sunderland, Tyne And Wear, United Kingdom, SR4 7TP
        • Novartis Investigative Site
    • West Midlands
      • Dudley, West Midlands, United Kingdom, DY1 2HQ
        • Novartis Investigative Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Novartis Investigative Site
      • Muscle Shoals, Alabama, United States, 35662
        • Novartis Investigative Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Novartis Investigative Site
    • California
      • Oceanside, California, United States, 92056
        • Novartis Investigative Site
      • Palm Springs, California, United States, 92262
        • Novartis Investigative Site
      • San Diego, California, United States, 92161
        • Novartis Investigative Site
      • Santa Rosa, California, United States, 95405
        • Novartis Investigative Site
    • Florida
      • Boynton Beach, Florida, United States, 33472-2952
        • Novartis Investigative Site
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Novartis Investigative Site
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Novartis Investigative Site
    • Maryland
      • Columbia, Maryland, United States, 21044
        • Novartis Investigative Site
    • Michigan
      • Saginaw, Michigan, United States, 48601
        • Novartis Investigative Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Novartis Investigative Site
    • Nebraska
      • Fremont, Nebraska, United States, 68025
        • Novartis Investigative Site
    • New York
      • New York, New York, United States, 10032
        • Novartis Investigative Site
      • Rosedale, New York, United States, 11422
        • Novartis Investigative Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27610
        • Novartis Investigative Site
    • Ohio
      • Marion, Ohio, United States, 43302
        • Novartis Investigative Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Novartis Investigative Site
    • Texas
      • Dallas, Texas, United States, 75235
        • Novartis Investigative Site
      • Dallas, Texas, United States, 75251
        • Novartis Investigative Site
      • Livingston, Texas, United States, 77351
        • Novartis Investigative Site
    • Washington
      • Spokane, Washington, United States, 99204
        • Novartis Investigative Site
    • Wisconsin
      • Waukesha, Wisconsin, United States, 53188
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Written informed consent for the extension must be obtained before any assessment is performed.
  2. Patients who have completed PARADIGM-HF (protocol CLCZ696B2314) and are able to be safely enrolled into the open-label trial as judged by the investigator.

Exclusion Criteria:

  1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
  2. History of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, ACEIs, ARBs, or NEP inhibitors as well as known or suspected contraindications to LCZ696
  3. Known history of angioedema
  4. Requirement of simultaneous treatment with both ACEIs and ARBs
  5. Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy)
  6. Symptomatic hypotension and/or a SBP < 100 mmHg at Visit 1 (screening)
  7. Estimated GFR < 30 mL/min/1.73m^2 as measured by the simplified MDRD formula at Visit 1 (screening)
  8. Presence of bilateral renal artery stenosis
  9. Serum potassium > 5.2 mmol/L at Visit 1 (screening)
  10. Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 3 x ULN at Visit 1, history of hepatic encephalopathy, history of esophageal varices, or history of portacaval shunt
  11. Pregnant or nursing (lactating) women
  12. Women of child-bearing potential
  13. Any condition, not identified in the protocol, that in the opinion of the investigator is likely to prevent the patient from safely tolerating LCZ696 or complying with the requirements of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LCZ696
Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid
Drug: LCZ696
Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths as a Measure of Safety and Tolerability of LCZ696
Time Frame: From first dose of study treatment to 30 days after last dose of study treatment, up to 30 months.
The primary assessments for safety were the reporting of angioedema, AEs suspected to be related to LCZ696, AEs leading to study drug discontinuation and serious adverse events (SAE) including death. The assessment of safety were based primarily on the frequency of adverse events of special interest, sitting systolic and diastolic blood pressure, heart rate, and serious adverse events suspected by the investigators to be related to LCZ696 for the Safety set. Only descriptive analysis done.
From first dose of study treatment to 30 days after last dose of study treatment, up to 30 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2014

Primary Completion (Actual)

December 28, 2017

Study Completion (Actual)

December 28, 2017

Study Registration Dates

First Submitted

August 25, 2014

First Submitted That Met QC Criteria

August 25, 2014

First Posted (Estimate)

August 27, 2014

Study Record Updates

Last Update Posted (Actual)

February 20, 2019

Last Update Submitted That Met QC Criteria

February 19, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLCZ696B2317
  • 2014-001971-30 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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