Chronic Heart Failure With Reduced Ejection FractionPhase 3NCT02226120
Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction
A Phase 3 study testing LCZ696 in people with Chronic Heart Failure With Reduced Ejection Fraction, run by Novartis Pharmaceuticals at 394 sites in 41 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Heart Failure With Reduced Ejection Fraction
- What is being tested?
- LCZ696
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,980 participants
- Where
- 394 sitesin 41 countries
- Study dates
- 16 Oct 2014to 28 Dec 2017
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written informed consent for the extension must be obtained before any assessment is performed.
- 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.
Who cannot join
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
- 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
- Known history of angioedema
- Requirement of simultaneous treatment with both ACEIs and ARBs
- Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy)
- Symptomatic hypotension and/or a SBP < 100 mmHg at Visit 1 (screening)
Show all 13Show fewer
- Estimated GFR < 30 mL/min/1.73m^2 as measured by the simplified MDRD formula at Visit 1 (screening)
- Presence of bilateral renal artery stenosis
- Serum potassium > 5.2 mmol/L at Visit 1 (screening)
- 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
- Pregnant or nursing (lactating) women
- Women of child-bearing potential
- 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.
Trial locations and contacts
394 sites in 41 countries.
394 sites in 41 countries
Russia35 sites
Novartis Investigative Site
Ivanovo, 153012
Novartis Investigative Site
Kazan', 420012
Novartis Investigative Site
Kemerovo, 650002
Novartis Investigative Site
Kirov, 610027
Novartis Investigative Site
Krasnodar, 350012
Novartis Investigative Site
Moscow, 101990
Novartis Investigative Site
Moscow, 115280
Novartis Investigative Site
Moscow, 115516
Novartis Investigative Site
Moscow, 117198
Novartis Investigative Site
Moscow, 119881
Novartis Investigative Site
Moscow, 121309
Novartis Investigative Site
Moscow, 121552
Novartis Investigative Site
Moscow, 127473
Novartis Investigative Site
N.Novgorod, 603005
Novartis Investigative Site
Nizhny Novgorod, 603003
Novartis Investigative Site
Nizhny Novgorod, 603126
Novartis Investigative Site
Novosibirsk-117, 630117
Novartis Investigative Site
Orenburg, 460000
Novartis Investigative Site
Orenburg, 460040
Novartis Investigative Site
Perm, 614097
Novartis Investigative Site
Rostov-on-Don, 344022
Novartis Investigative Site
S-Petersburg, 194354
Novartis Investigative Site
Saint Petersburg, 191144
Novartis Investigative Site
Saint Petersburg, 194017
Novartis Investigative Site
Saint Petersburg, 194044
Novartis Investigative Site
Saint Petersburg, 194295
Novartis Investigative Site
Saint Petersburg, 196084
Novartis Investigative Site
Saint Petersburg, 197022
Novartis Investigative Site
Saint Petersburg, 197341
Novartis Investigative Site
Saint Petersburg, 199106
Novartis Investigative Site
Saratov, 410012
Novartis Investigative Site
Smolensk, 214018
Novartis Investigative Site
Tula, 300053
Novartis Investigative Site
Vladimir, 600020
Novartis Investigative Site
Yekaterinburg, 620137
Germany29 sites
Novartis Investigative Site
Bad Homburg, 61348
Novartis Investigative Site
Bad Krozingen, 79189
Novartis Investigative Site
Berlin, 10369
Novartis Investigative Site
Berlin, 13405
Novartis Investigative Site
Buch, 13125
Novartis Investigative Site
Dessau, 06846
Novartis Investigative Site
Dresden, Saxony, 01099
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Dresden, 01309
Novartis Investigative Site
Elsterwerda, 04910
Novartis Investigative Site
Frankfurt, 60488
Novartis Investigative Site
Frankfurt, 65929
Novartis Investigative Site
Hamburg, 22291
Novartis Investigative Site
Hamburg, 22765
Novartis Investigative Site
Huy / OT Anderbeck, 38836
Novartis Investigative Site
Ingelheim, 55218
Novartis Investigative Site
Kelkheim, 65779
Novartis Investigative Site
Köthen, 06366
Novartis Investigative Site
Künzelsau, 74653
Novartis Investigative Site
Leipzig, 04109
Novartis Investigative Site
Leipzig, 04129
Novartis Investigative Site
Leipzig, 04315
Novartis Investigative Site
Löhne, 32584
Novartis Investigative Site
Muehlheim An Der Ruhr, 45468
Novartis Investigative Site
Mühldorf, 84453
Novartis Investigative Site
Offenbach, 63073
Novartis Investigative Site
Wermsdorf, 04779
Novartis Investigative Site
Wetzlar-Naunheim, 35584
Novartis Investigative Site
Weyhe, 28844
United Kingdom28 sites
Novartis Investigative Site
Basingstoke, Hampshire, RG24 9NA
Novartis Investigative Site
Cheshire, CW1 4QJ
Novartis Investigative Site
Coventry, CV2 2DX
Novartis Investigative Site
Craigavon, Northern Ireland, BT63 5QQ
Novartis Investigative Site
Dorchester, Dorset, DT1 2JY
Novartis Investigative Site
Dudley, West Midlands, DY1 2HQ
Novartis Investigative Site
Dundee, Perthshire, DD1 9SY
Novartis Investigative Site
Durham, County Durham, DH1 5TW
Novartis Investigative Site
Exeter, EX2 5AX
Novartis Investigative Site
Inverness, Invernesshire, IV2 3RE
Novartis Investigative Site
Kent, DA2 8DA
Novartis Investigative Site
Leicester, Leicestershire, LE2 7LX
Novartis Investigative Site
Manchester, M13 9WL
Novartis Investigative Site
Milton Keynes, MK6 5LD
Novartis Investigative Site
Newport, NP20 2UB
Novartis Investigative Site
Newport, P030 5TG
Novartis Investigative Site
Norwich, NR4 7UY
Novartis Investigative Site
Oldham, Lancashire, OL1 2JH
Novartis Investigative Site
Poole, BH15 2JB
Novartis Investigative Site
Portsmouth, Hampshire, PO6 3LY
Novartis Investigative Site
Redhill, Surrey, RH1 5RH
Novartis Investigative Site
Rotherham, S60 2OD
Novartis Investigative Site
Sheffield, South Yorkshire, S10 2JF
Novartis Investigative Site
South Shields, Tyne and Wear, NE34 0PL
Novartis Investigative Site
Sunderland, Tyne and Wear, SR4 7TP
Novartis Investigative Site
Taunton, Somerset, TA1 5DA
Novartis Investigative Site
Worcester, WR5 1DD
Novartis Investigative Site
Yeovil, Somerset, BA21 4AT
United States24 sites
Novartis Investigative Site
Boynton Beach, Florida, 33472-2952
Novartis Investigative Site
Columbia, Maryland, 21044
Novartis Investigative Site
Covington, Louisiana, 70433
Novartis Investigative Site
Dallas, Texas, 75235
Novartis Investigative Site
Dallas, Texas, 75251
Novartis Investigative Site
Des Moines, Iowa, 50314
Novartis Investigative Site
Fremont, Nebraska, 68025
Novartis Investigative Site
Huntsville, Alabama, 35801
Novartis Investigative Site
Little Rock, Arkansas, 72204
Novartis Investigative Site
Livingston, Texas, 77351
Novartis Investigative Site
Marion, Ohio, 43302
Novartis Investigative Site
Minneapolis, Minnesota, 55417
Novartis Investigative Site
Muscle Shoals, Alabama, 35662
Novartis Investigative Site
New York, New York, 10032
Novartis Investigative Site
Oceanside, California, 92056
Novartis Investigative Site
Palm Springs, California, 92262
Novartis Investigative Site
Raleigh, North Carolina, 27610
Novartis Investigative Site
Rapid City, South Dakota, 57701
Novartis Investigative Site
Rosedale, New York, 11422
Novartis Investigative Site
Saginaw, Michigan, 48601
Novartis Investigative Site
San Diego, California, 92161
Novartis Investigative Site
Santa Rosa, California, 95405
Novartis Investigative Site
Spokane, Washington, 99204
Novartis Investigative Site
Waukesha, Wisconsin, 53188
Argentina21 sites
Novartis Investigative Site
CABA, Buenos Aires, C1221ADC
Novartis Investigative Site
CABA, Buenos Aires F.D., C1179AAB
Novartis Investigative Site
Ciudad Autonoma de Bs As, Buenos Aires, C1119ACN
Novartis Investigative Site
Córdoba, 5000
Novartis Investigative Site
Córdoba, X5000AAX
Novartis Investigative Site
Córdoba, X5016KET
Novartis Investigative Site
Corrientes, W3400CLH
Novartis Investigative Site
Formosa, P3600
Novartis Investigative Site
Formosa, P3634XAR
Novartis Investigative Site
Mar del Plata, Buenos Aires, B7600FZN
Novartis Investigative Site
Mendoza, M5500CHC
Novartis Investigative Site
Quilmes, Buenos Aires, B1878DVB
Novartis Investigative Site
Rosario, Santa Fe Province, 2000
Novartis Investigative Site
Rosario, Santa Fe Province, S2000AII
Novartis Investigative Site
Rosario, Santa Fe Province, S2000QID
Novartis Investigative Site
Salta, Salta Province, A4406BPF
Novartis Investigative Site
San Luis, D5702JRS
Novartis Investigative Site
San Salvador de Jujuy, Jujuy Province, Y4600ABF
Novartis Investigative Site
Santa Fe, S3000EOZ
Novartis Investigative Site
Santa Fe, S3000FWO
Novartis Investigative Site
Santiago del Estero, G4200AQK
Brazil20 sites
Novartis Investigative Site
Belém, Pará, 66087-660
Novartis Investigative Site
Belo Horizonte, Minas Gerais, 20180-090
Novartis Investigative Site
Belo Horizonte, Minas Gerais, 30150-221
Novartis Investigative Site
Brasília, Federal District, 70390-903
Novartis Investigative Site
Goiânia, Goiás, 74223-130
Novartis Investigative Site
Goiânia, Goiás, 74605 050
Novartis Investigative Site
Goiânia, Goiás, 74823-470
Novartis Investigative Site
Marília, São Paulo, 17515-000
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90880-480
Novartis Investigative Site
Recife, Pernambuco, 52051-380
Novartis Investigative Site
Ribeirão Preto, São Paulo, 14055-370
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 22280-020
Novartis Investigative Site
Salvador, Estado de Bahia, 41810-010
Novartis Investigative Site
Santo André, São Paulo, 09190-615
Novartis Investigative Site
São José do Rio Preto, São Paulo, 15015-750
Novartis Investigative Site
São Luís, Maranhão, 65020-070
Novartis Investigative Site
São Paulo, São Paulo, 01323 000
Novartis Investigative Site
São Paulo, São Paulo, 05403-000
Novartis Investigative Site
Uberlândia, Mg-cep, 38411-186
Novartis Investigative Site
Votuporanga, São Paulo, 15500-003
India20 sites
Novartis Investigative Site
Ahmedabad, Gujarat, 380 051
Novartis Investigative Site
Ahmedabad, Gujarat, 380054
Novartis Investigative Site
Anand, Gujarat, 388325
Novartis Investigative Site
Bikaner, Rajasthan, 334003
Novartis Investigative Site
Delhi, National Capital Territory of Delhi, 110080
Novartis Investigative Site
Guntur, Andhra Pradesh, 522001
Novartis Investigative Site
Hyderabad, Telangana, 500 063
Novartis Investigative Site
Indore, 452014
Novartis Investigative Site
Ludhiana, Punjab, 141002
Novartis Investigative Site
Mumbai, Maharashtra, 400012
Novartis Investigative Site
Nagpur, Maharashtra, 400012
Novartis Investigative Site
Nagpur, Maharashtra, 440010
Novartis Investigative Site
Nashik, Maharashtra, 422 005
Novartis Investigative Site
Nashik, Maharashtra, 422002
Novartis Investigative Site
Nashik, Maharashtra, 422005
Novartis Investigative Site
Pune, Maharashtra, 411 011
Novartis Investigative Site
Pune, Maharashtra, 411011
Novartis Investigative Site
Surat, Gujarat, 395 002
Novartis Investigative Site
Surat, Gujarat, 395002
Novartis Investigative Site
Vadodara, Gujarat, 390015
Italy17 sites
Novartis Investigative Site
Aosta, AO, 11100
Novartis Investigative Site
Ariccia, RM, 00041
Novartis Investigative Site
Bergamo, BG, 24127
Novartis Investigative Site
Cona, FE, 44100
Novartis Investigative Site
Cortona, AR, 52044
Novartis Investigative Site
Cosenza, CS, 87100
Novartis Investigative Site
Genova, GE, 16132
Novartis Investigative Site
Lido di Camaiore, LU, 55041
Novartis Investigative Site
Milazzo, ME, 98057
Novartis Investigative Site
Pavia, PV, 27100
Novartis Investigative Site
Pescia, Point, 51017
Novartis Investigative Site
Pisa, PI, 56126
Novartis Investigative Site
Pozzilli, IS, 86077
Novartis Investigative Site
Roma, RM, 00163
Novartis Investigative Site
Salerno, SA, 84131
Novartis Investigative Site
Sassari, SS, 07100
Novartis Investigative Site
Treviglio, BG, 24047
Netherlands15 sites
Novartis Investigative Site
's-Hertogenbosch, 5223 GZ
Novartis Investigative Site
Amersfoort, 3813 TZ
Novartis Investigative Site
Arnhem, 6815 AD
Novartis Investigative Site
Blaricum, 1261 AN
Novartis Investigative Site
Breda, CK, 4818
Novartis Investigative Site
Delft, 2625 AD
Novartis Investigative Site
Ede, 6716 RP
Novartis Investigative Site
Gorinchem, 4204 AA
Novartis Investigative Site
Hardenberg, 7770 AA
Novartis Investigative Site
Harderwijk, 3840 AC
Novartis Investigative Site
Heerenveen, 8441 PW
Novartis Investigative Site
Hengelo, 7555 DL
Novartis Investigative Site
Sneek, 8601 ZK
Novartis Investigative Site
Tilburg, 5022 GC
Novartis Investigative Site
Veldhoven, 5504 DB
Spain15 sites
Novartis Investigative Site
A Coruña, Galicia, 15006
Novartis Investigative Site
Alcalá de Henares, Madrid, 28805
Novartis Investigative Site
Barcelona, Catalonia, 08003
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Madrid, 28007
Novartis Investigative Site
Madrid, 28222
Novartis Investigative Site
Málaga, Andalusia, 29010
Novartis Investigative Site
Marbella, Andalusia, 29600
Novartis Investigative Site
Móstoles, Madrid, 28935
Novartis Investigative Site
Sant Joan Despí, Catalonia, 08970
Novartis Investigative Site
Santiago de Compostela, Galicia, 15706
Novartis Investigative Site
Seville, Andalusia, 41014
Novartis Investigative Site
Valencia, Valencia, 46010
Novartis Investigative Site
Valencia, Valencia, 46015
Novartis Investigative Site
Vigo, Galicia, 36211
South Africa14 sites
Novartis Investigative Site
Alberton, 1449
Novartis Investigative Site
Bloemfontein, Free State, 9301
Novartis Investigative Site
Bloemfontein, 9301
Novartis Investigative Site
Cape Town, Western Cape, 7405
Novartis Investigative Site
Cape Town, 7405
Novartis Investigative Site
Cape Town, 7505
Novartis Investigative Site
Durban, KwaZulu-Natal, 4052
Novartis Investigative Site
Durban, 4110
Novartis Investigative Site
Johannesburg, 2193
Novartis Investigative Site
Kempton Park, 1620
Novartis Investigative Site
Pretoria, 0121
Novartis Investigative Site
Pretoria, 0184
Novartis Investigative Site
Soweto, Gauteng, 2013
Novartis Investigative Site
Worcester, 6850
Czechia11 sites
Novartis Investigative Site
Beroun, Czech Republic, 266 01
Novartis Investigative Site
Bílovec, CZE, 743 01
Novartis Investigative Site
Brandýs nad Labem, Czech Republic, 250 01
Novartis Investigative Site
Kolín, 280 20
Novartis Investigative Site
Liberec V Kristianova, Czech Republic, 460 05
Novartis Investigative Site
Olomouc, Czech Republic, 779 00
Novartis Investigative Site
Prague, 12808
Novartis Investigative Site
Prague, 150 30
Novartis Investigative Site
Prague 10, Vrsovice, Czech Republic, 10100
Novartis Investigative Site
Třebíč, Czech Republic, 674 01
Novartis Investigative Site
Uherské Hradiště, 68601
Slovakia11 sites
Novartis Investigative Site
Bratislava, 821 07
Novartis Investigative Site
Bratislava, 842 31
Novartis Investigative Site
Bratislava, 851 07
Novartis Investigative Site
Brezno, Slovak Republic, 977 42
Novartis Investigative Site
Košice, Slovak Republic, 040 22
Novartis Investigative Site
Košice, 040 01
Novartis Investigative Site
Levice, Slovak Republic, 93401
Novartis Investigative Site
Lučenec, 984 01
Novartis Investigative Site
Martin, 036 01
Novartis Investigative Site
Prešov, Slovak Republic, 08001
Novartis Investigative Site
Svidník, Slovak Republic, 08901
Bulgaria10 sites
Novartis Investigative Site
Haskovo, 6300
Novartis Investigative Site
Pleven, 5800
Novartis Investigative Site
Plovdiv, 4000
Novartis Investigative Site
Shumen, 9700
Novartis Investigative Site
Sofia, 1233
Novartis Investigative Site
Sofia, 1309
Novartis Investigative Site
Sofia, 1431
Novartis Investigative Site
Sofia, 1527
Novartis Investigative Site
Sofia, 1606
Novartis Investigative Site
Varna, 9010
Hungary10 sites
Novartis Investigative Site
Budapest, 1096
Novartis Investigative Site
Budapest, 1122
Novartis Investigative Site
Budapest, 1125
Novartis Investigative Site
Budapest, 1134
Novartis Investigative Site
Budapest, 1145
Novartis Investigative Site
Debrecen, 4032
Novartis Investigative Site
Nyiregyháza, 4400
Novartis Investigative Site
Székesfehérvár, H-8000
Novartis Investigative Site
Szekszárd, 7100
Novartis Investigative Site
Zalaegerszeg, 8900
Romania10 sites
Novartis Investigative Site
Bucharest, District 1, 014461
Novartis Investigative Site
Bucharest, District 1
Novartis Investigative Site
Bucharest, 011728
Novartis Investigative Site
Bucharest, 050098
Novartis Investigative Site
Craiova, Jud. Dolj, 200497
Novartis Investigative Site
Craiova, 200642
Novartis Investigative Site
Deva, 330084
Novartis Investigative Site
Timișoara, Timiș County, 300362
Novartis Investigative Site
Timișoara, 300041
Novartis Investigative Site
Timișoara, 300736
Canada9 sites
Novartis Investigative Site
Halifax, Nova Scotia, B3H 2Y9
Novartis Investigative Site
Kitchener, Ontario, N2M 5N4
Novartis Investigative Site
Lévis, Quebec, G6V 4Z5
Novartis Investigative Site
Montreal, Quebec, H3G 1A4
Novartis Investigative Site
Montreal, Quebec, H3T 1E2
Novartis Investigative Site
St-Georges Beauce, Quebec, G5Y 4T8
Novartis Investigative Site
Toronto, Ontario, M5B 1W8
Novartis Investigative Site
Victoria, British Columbia, V8R4R2
Novartis Investigative Site
Weston, Ontario, M9N 1W4
Israel8 sites
Novartis Investigative Site
Ashkelon, 78278
Novartis Investigative Site
Hadera, 38100
Novartis Investigative Site
Haifa, 3436212
Novartis Investigative Site
Haifa, 3525408
Novartis Investigative Site
Jerusalem, 91120
Novartis Investigative Site
Petah Tikva, 49100
Novartis Investigative Site
Rehovot, 76100
Novartis Investigative Site
Safed, 13100
South Korea8 sites
Novartis Investigative Site
Daegu, 705 718
Novartis Investigative Site
Daegu, 705703
Novartis Investigative Site
Seoul, Korea, 05505
Novartis Investigative Site
Seoul, Seocho-gu, 06591
Novartis Investigative Site
Seoul, 05355
Novartis Investigative Site
Seoul, 156-707
Novartis Investigative Site
Suwon, Gyeonggi-do, 16499
Novartis Investigative Site
Wŏnju, Gangwon-do, 26426
Denmark7 sites
Novartis Investigative Site
Copenhagen, DK-2100
Novartis Investigative Site
Esbjerg, DK-6700
Novartis Investigative Site
Hellerup, DK-2900
Novartis Investigative Site
Randers, 8930
Novartis Investigative Site
Svendborg, 5700
Novartis Investigative Site
Vejle, 7100
Novartis Investigative Site
Viborg, DK-8800
Peru7 sites
Novartis Investigative Site
Arequipa, AREQ01
Novartis Investigative Site
Bellavista, Lima region, CALLAO 02
Novartis Investigative Site
Jesus Maria, Lima region, 11
Novartis Investigative Site
La Molina, Lima region, 12
Novartis Investigative Site
San Borja, Lima region, 41
Novartis Investigative Site
San Isidro, Lima region, 27
Novartis Investigative Site
San Miguel, Lima region, 32
Portugal7 sites
Novartis Investigative Site
Covilha, 6200-251
Novartis Investigative Site
Guimarães, 4835-044
Novartis Investigative Site
Lisbon, 1449-005
Novartis Investigative Site
Portalegre, 7300-853
Novartis Investigative Site
Porto, 4200-319
Novartis Investigative Site
Setúbal, 2910-446
Novartis Investigative Site
Vila Real, Portuigal, 5000-508
Taiwan7 sites
Novartis Investigative Site
Changhua, 50006
Novartis Investigative Site
Kaohsiung City, 82445
Novartis Investigative Site
Taichung, 40447
Novartis Investigative Site
Taipei, 10002
Novartis Investigative Site
Taipei, 11217
Novartis Investigative Site
Taipei, 114
Novartis Investigative Site
Yilan, 26058
Turkey (Türkiye)6 sites
Novartis Investigative Site
Istanbul, 34093
Novartis Investigative Site
Istanbul, 34304
Novartis Investigative Site
Izmir, 35040
Novartis Investigative Site
Izmir, 35340
Novartis Investigative Site
Kocaeli, 41380
Novartis Investigative Site
Sivas, 58140
Belgium5 sites
Novartis Investigative Site
Brasschaat, 2930
Novartis Investigative Site
Ghent, 9000
Novartis Investigative Site
La Louvière, 7100
Novartis Investigative Site
Leuven, 3000
Novartis Investigative Site
Ronse, 9600
Philippines5 sites
Novartis Investigative Site
Lipa City, Batangas, 4217
Novartis Investigative Site
Pasig, 1605
Novartis Investigative Site
Quezon City, Manila, 1100
Novartis Investigative Site
Quezon City, 1100
Novartis Investigative Site
Quezon City, 1102
Sweden4 sites
Novartis Investigative Site
Gothenburg, 416 85
Novartis Investigative Site
Karlshamn, 37480
Novartis Investigative Site
Motala, 59185
Novartis Investigative Site
Stockholm, SE, 141 86
Guatemala3 sites
Novartis Investigative Site
Guatemala City, Ciudad, 01010
Novartis Investigative Site
Guatemala City, 01010
Novartis Investigative Site
Guatemala City, 01015
Lithuania3 sites
Novartis Investigative Site
Kaunas, LT-49387
Novartis Investigative Site
Kėdainiai, LT-57164
Novartis Investigative Site
Vilnius, LT-08661
Mexico3 sites
Novartis Investigative Site
Aguascalientes, 20230
Novartis Investigative Site
San Juan del Río, Querétaro, 76800
Novartis Investigative Site
San Luis Potosí City, 78200
Poland3 sites
Novartis Investigative Site
Gdynia, 81-472
Novartis Investigative Site
Gdynia, 81-548
Novartis Investigative Site
Lublin, 20-857
Thailand3 sites
Novartis Investigative Site
Khon Kaen, THA, 40002
Novartis Investigative Site
Muang, Thailand, 12120
Novartis Investigative Site
Taladkwan, Changwat Nonthaburi, 11000
Estonia2 sites
Novartis Investigative Site
Tallinn, 13419
Novartis Investigative Site
Tartu, 50410
France2 sites
Novartis Investigative Site
Montpellier, Herault, 34059
Novartis Investigative Site
Paris, 75015
Hong Kong2 sites
Novartis Investigative Site
Hong Kong, HONG KONG
Novartis Investigative Site
Hong Kong SAR
Latvia2 sites
Novartis Investigative Site
Daugavpils, LV-5417
Novartis Investigative Site
Ventspils, LV-3601
Malaysia2 sites
Novartis Investigative Site
Kuala Lumpur, 50400
Novartis Investigative Site
Kuala Lumpur, 59100
Panama2 sites
Novartis Investigative Site
Panama City, 0816-02351
Novartis Investigative Site
Panama City
Singapore2 sites
Novartis Investigative Site
Singapore, 169609
Novartis Investigative Site
Singapore, 308433
About this study
Official title: 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.
- Being tested
- LCZ696
- Keywords
- LCZ696, chronic heart failure, ARNI, Congestive heart failure (CHF), heart failure (HF), acute heart failure syndrome, congestive cardiac failure (CCF)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCZ696Drug
Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid
| Study group | Role | What they receive |
|---|---|---|
| LCZ696 | Experimental | Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid Receives: Drug: LCZ696 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths as a Measure of Safety and Tolerability of LCZ696
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.
Measured: From first dose of study treatment to 30 days after last dose of study treatment, up to 30 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study start16 Oct 2014
- Primary completion28 Dec 2017
- Study completion28 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,980 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226120
- Sponsor's protocol ID
- CLCZ696B2317
- Other IDs
- 2014-001971-30, 2014
- Status last verified
- Feb 2019
- First submitted
- 25 Aug 2014
- Last updated
- 20 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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