- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01920711
Effekt og sikkerhed af LCZ696 sammenlignet med valsartan, om sygelighed og dødelighed hos hjertesvigtpatienter med bevaret ejektionsfraktion (PARAGON-HF)
En multicenter, randomiseret, dobbeltblind, parallel gruppe, aktiv-kontrolleret undersøgelse til evaluering af effektiviteten og sikkerheden af LCZ696 sammenlignet med valsartan, om morbiditet og dødelighed hos hjertesvigtspatienter (NYHA klasse II-IV) med bevaret ejektionsfraktion (PARAGON- HF)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Dette var et multicenter, randomiseret, dobbeltblindt, parallelgruppe, aktivt-kontrolleret, studie for at evaluere effektiviteten og sikkerheden af sacubitril/valsartan sammenlignet med valsartan, på morbiditet og mortalitet hos hjertesvigtpatienter (NYHA klasse II-IV) med bevaret udstødningsfraktion. Specifikt evaluerede undersøgelsen effekten af sacubitril/valsartan sammenlignet med den aktive komparator valsartan i reduktionen af antallet af CV-dødsfald og samlede HF-indlæggelser hos patienter med HFpEF. Forsøget bestod af to perioder: (1) en enkeltblind behandlingsindkøringsepoke, der varede fra 3 til 8 uger, hvor patienterne fik valsartan 80 mg to gange dagligt efterfulgt af sacubitril/valsartan 100 mg to gange dagligt og (2) en dobbelt -blind randomiseret behandlingsperiode (sacubitril/valsartan 200 mg to gange dagligt eller valsartan 160 mg to gange dagligt). I denne undersøgelse var efterforskerne ansvarlige for at vurdere og indsende alle hændelser, som potentielt kunne opfylde kriterierne for de primære, sekundære eller andre kliniske endepunkter til en Clinical Endpoint Committee (CEC). Efterforsker rapporterede hændelser blev vurderet af CEC med henblik på bedømmelse.
For angioødem eller angioødem-lignende hændelser udfyldte efterforskerne et bedømmelsesspørgeskema til en angioødem-lignende hændelsesformular. Alle rapporter om angioødem blev sendt til en angioødem-bedømmelseskomité (AAC) af Novartis til vurdering.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
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Buffalo, New York, Forenede Stater, 14215
- Novartis Investigative Site
-
Buffalo, New York, Forenede Stater, 14203
- Novartis Investigative Site
-
Flushing, New York, Forenede Stater, 11355
- Novartis Investigative Site
-
Kingston, New York, Forenede Stater, 12401
- Novartis Investigative Site
-
Northport, New York, Forenede Stater, 11768
- Novartis Investigative Site
-
Rochester, New York, Forenede Stater, 14642
- Novartis Investigative Site
-
Saratoga Springs, New York, Forenede Stater, 12866
- Novartis Investigative Site
-
-
North Carolina
-
Chapel Hill, North Carolina, Forenede Stater, 27599-7075
- Novartis Investigative Site
-
Winston-Salem, North Carolina, Forenede Stater, 27157
- Novartis Investigative Site
-
-
North Dakota
-
Grand Forks, North Dakota, Forenede Stater, 58201
- Novartis Investigative Site
-
-
Ohio
-
Canton, Ohio, Forenede Stater, 44710
- Novartis Investigative Site
-
Marion, Ohio, Forenede Stater, 43302
- Novartis Investigative Site
-
-
Oklahoma
-
Tulsa, Oklahoma, Forenede Stater, 74133
- Novartis Investigative Site
-
-
Oregon
-
Portland, Oregon, Forenede Stater, 97225
- Novartis Investigative Site
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19107
- Novartis Investigative Site
-
Yardley, Pennsylvania, Forenede Stater, 19067
- Novartis Investigative Site
-
-
Rhode Island
-
Providence, Rhode Island, Forenede Stater, 02908
- Novartis Investigative Site
-
Warwick, Rhode Island, Forenede Stater, 02886
- Novartis Investigative Site
-
-
South Carolina
-
Charleston, South Carolina, Forenede Stater, 29403
- Novartis Investigative Site
-
-
South Dakota
-
Rapid City, South Dakota, Forenede Stater, 57701
- Novartis Investigative Site
-
Sioux Falls, South Dakota, Forenede Stater, 57104
- Novartis Investigative Site
-
-
Tennessee
-
Knoxville, Tennessee, Forenede Stater, 37917
- Novartis Investigative Site
-
Memphis, Tennessee, Forenede Stater, 38104
- Novartis Investigative Site
-
Nashville, Tennessee, Forenede Stater, 37203
- Novartis Investigative Site
-
Nashville, Tennessee, Forenede Stater, 37212
- Novartis Investigative Site
-
-
Texas
-
Beaumont, Texas, Forenede Stater, 77702
- Novartis Investigative Site
-
Dallas, Texas, Forenede Stater, 75216
- Novartis Investigative Site
-
Dallas, Texas, Forenede Stater, 75235
- Novartis Investigative Site
-
Dallas, Texas, Forenede Stater, 75231
- Novartis Investigative Site
-
Houston, Texas, Forenede Stater, 77030
- Novartis Investigative Site
-
Houston, Texas, Forenede Stater, 77094
- Novartis Investigative Site
-
Livingston, Texas, Forenede Stater, 77351
- Novartis Investigative Site
-
McKinney, Texas, Forenede Stater, 75069
- Novartis Investigative Site
-
San Antonio, Texas, Forenede Stater, 78234
- Novartis Investigative Site
-
Tomball, Texas, Forenede Stater, 77375
- Novartis Investigative Site
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 84132
- Novartis Investigative Site
-
Salt Lake City, Utah, Forenede Stater, 84124
- Novartis Investigative Site
-
-
Vermont
-
White River Junction, Vermont, Forenede Stater, 05009
- Novartis Investigative Site
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98122
- Novartis Investigative Site
-
Seattle, Washington, Forenede Stater, 98195
- Novartis Investigative Site
-
-
Wisconsin
-
Madison, Wisconsin, Forenede Stater, 53705
- Novartis Investigative Site
-
Madison, Wisconsin, Forenede Stater, 53792-1615
- Novartis Investigative Site
-
Milwaukee, Wisconsin, Forenede Stater, 53215
- Novartis Investigative Site
-
-
-
-
-
Besancon Cedex, Frankrig, 25030
- Novartis Investigative Site
-
Beziers Cedex, Frankrig, 34525
- Novartis Investigative Site
-
Bordeaux Cedex, Frankrig, 33075
- Novartis Investigative Site
-
Grenoble, Frankrig, 38043
- Novartis Investigative Site
-
Lyon, Frankrig, F-69001
- Novartis Investigative Site
-
Paris cedex 10, Frankrig, 75010
- Novartis Investigative Site
-
Poitiers, Frankrig, 86000
- Novartis Investigative Site
-
Pontoise, Frankrig, F-95300
- Novartis Investigative Site
-
Rennes Cedex 9, Frankrig, 35033
- Novartis Investigative Site
-
Toulouse Cedex, Frankrig, 31059
- Novartis Investigative Site
-
Tourcoing, Frankrig, 59208
- Novartis Investigative Site
-
Vandoeuvre Les Nancy, Frankrig, 54511
- Novartis Investigative Site
-
-
Bayonne Cedex
-
Bayonne, Bayonne Cedex, Frankrig, 64109
- Novartis Investigative Site
-
-
Herault
-
Montpellier cedex 5, Herault, Frankrig, 34059
- Novartis Investigative Site
-
-
-
-
-
Athens, Grækenland, 115 27
- Novartis Investigative Site
-
Athens, Grækenland, 12462
- Novartis Investigative Site
-
Thessaloniki, Grækenland, GR 54636
- Novartis Investigative Site
-
Thessaloniki, Grækenland, 54642
- Novartis Investigative Site
-
-
Attica
-
Athens, Attica, Grækenland, 15562
- Novartis Investigative Site
-
-
GR
-
Athens, GR, Grækenland, 14233
- Novartis Investigative Site
-
Ioannina, GR, Grækenland, 455 00
- Novartis Investigative Site
-
Larissa, GR, Grækenland, 411 10
- Novartis Investigative Site
-
-
-
-
-
Guatemala City, Guatemala, 01010
- Novartis Investigative Site
-
Guatemala City, Guatemala, 01011
- Novartis Investigative Site
-
Guatemala City, Guatemala, 01015
- Novartis Investigative Site
-
Guatemala City, Guatemala, 10110
- Novartis Investigative Site
-
-
-
-
-
Arnhem, Holland, 6815 AD
- Novartis Investigative Site
-
Blaricum, Holland, 1261 AN
- Novartis Investigative Site
-
Den Haag, Holland, 2512 VA
- Novartis Investigative Site
-
Ede, Holland, 6716 RP
- Novartis Investigative Site
-
Gouda, Holland, 2803 HH
- Novartis Investigative Site
-
Groningen, Holland, 9713 GZ
- Novartis Investigative Site
-
Hardenberg, Holland, 7770 AA
- Novartis Investigative Site
-
Harderwijk, Holland, 3840 AC
- Novartis Investigative Site
-
Nijmegen, Holland, 6500 HB
- Novartis Investigative Site
-
Rotterdam, Holland, 3015 CE
- Novartis Investigative Site
-
Sneek, Holland, 8601 ZK
- Novartis Investigative Site
-
Tilburg, Holland, 5022 GC
- Novartis Investigative Site
-
-
DZ
-
Apeldoorn, DZ, Holland, 7334
- Novartis Investigative Site
-
-
NL
-
Den Haag, NL, Holland, 2597 AX
- Novartis Investigative Site
-
-
PP
-
Almelo, PP, Holland, 7609
- Novartis Investigative Site
-
-
-
-
-
New Delhi, Indien, 110025
- Novartis Investigative Site
-
-
Andhra Pradesh
-
Guntur, Andhra Pradesh, Indien, 522001
- Novartis Investigative Site
-
Vishakhapatnam, Andhra Pradesh, Indien, 532 002
- Novartis Investigative Site
-
-
Delhi
-
New Delhi, Delhi, Indien, 110 060
- Novartis Investigative Site
-
-
Gujarat
-
Ahmedabad, Gujarat, Indien, 380054
- Novartis Investigative Site
-
Surat, Gujarat, Indien, 395 002
- Novartis Investigative Site
-
-
Haryana
-
Chandigarh, Haryana, Indien, 160 030
- Novartis Investigative Site
-
Gurgaon, Haryana, Indien, 122001
- Novartis Investigative Site
-
-
Kerala
-
Kochi, Kerala, Indien, 683 594
- Novartis Investigative Site
-
-
Maharashtra
-
Pune, Maharashtra, Indien, 411 030
- Novartis Investigative Site
-
-
Punjab
-
Ludhiana, Punjab, Indien, 141002
- Novartis Investigative Site
-
-
Rajasthan
-
Bikaner, Rajasthan, Indien, 334003
- Novartis Investigative Site
-
-
Tamil NADU
-
Chennai, Tamil NADU, Indien, 600037
- Novartis Investigative Site
-
Madurai, Tamil NADU, Indien, 625107
- Novartis Investigative Site
-
-
Tamil Nadu
-
Chennai, Tamil Nadu, Indien, 600081
- Novartis Investigative Site
-
-
West Bengal
-
Kolkata, West Bengal, Indien, 700 020
- Novartis Investigative Site
-
-
-
-
-
Hadera, Israel
- Novartis Investigative Site
-
Hadera, Israel, 38100
- Novartis Investigative Site
-
Haifa, Israel, 3525408
- Novartis Investigative Site
-
Haifa, Israel, 3339419
- Novartis Investigative Site
-
Lower Galilee, Israel, 15208
- Novartis Investigative Site
-
Nahariya, Israel, 22100
- Novartis Investigative Site
-
Petach Tikva, Israel, 49100
- Novartis Investigative Site
-
Ramat Gan, Israel, 52621
- Novartis Investigative Site
-
Rehovot, Israel, 76100
- Novartis Investigative Site
-
Tel Giborim, Holon, Israel, 58100
- Novartis Investigative Site
-
-
-
-
-
Milano, Italien, 20149
- Novartis Investigative Site
-
Napoli, Italien, 80131
- Novartis Investigative Site
-
-
AO
-
Aosta, AO, Italien, 11100
- Novartis Investigative Site
-
-
AR
-
Cortona, AR, Italien, 52044
- Novartis Investigative Site
-
-
BG
-
Bergamo, BG, Italien, 24127
- Novartis Investigative Site
-
Treviglio, BG, Italien, 24047
- Novartis Investigative Site
-
-
BO
-
Bologna, BO, Italien, 40138
- Novartis Investigative Site
-
-
BS
-
Brescia, BS, Italien, 25123
- Novartis Investigative Site
-
-
FE
-
Cona, FE, Italien, 44100
- Novartis Investigative Site
-
-
IS
-
Pozzilli, IS, Italien, 86077
- Novartis Investigative Site
-
-
MB
-
Monza, MB, Italien, 20900
- Novartis Investigative Site
-
-
ME
-
Messina, ME, Italien, 98125
- Novartis Investigative Site
-
-
MI
-
Milano, MI, Italien, 20162
- Novartis Investigative Site
-
Vimercate, MI, Italien, 200059
- Novartis Investigative Site
-
-
PD
-
Padova, PD, Italien, 35128
- Novartis Investigative Site
-
-
PG
-
Perugia, PG, Italien, 06100
- Novartis Investigative Site
-
Perugia, PG, Italien, 06129
- Novartis Investigative Site
-
-
PV
-
Pavia, PV, Italien, 27100
- Novartis Investigative Site
-
-
RM
-
Ariccia, RM, Italien, 00041
- Novartis Investigative Site
-
Roma, RM, Italien, 00189
- Novartis Investigative Site
-
Roma, RM, Italien, 00163
- Novartis Investigative Site
-
-
SS
-
Sassari, SS, Italien, 07100
- Novartis Investigative Site
-
-
TS
-
Trieste, TS, Italien, 34149
- Novartis Investigative Site
-
Trieste, TS, Italien, 34142
- Novartis Investigative Site
-
-
UD
-
Palmanova, UD, Italien, 33057
- Novartis Investigative Site
-
San Daniele Del Friuli, UD, Italien, 33038
- Novartis Investigative Site
-
-
VE
-
Venezia, VE, Italien, 30174
- Novartis Investigative Site
-
-
Va
-
Saronno, Va, Italien, 21047
- Novartis Investigative Site
-
-
-
-
Aichi
-
Seto-city, Aichi, Japan, 489-8642
- Novartis Investigative Site
-
-
Fukuka
-
Chikushino-city, Fukuka, Japan, 818-8516
- Novartis Investigative Site
-
-
Gifu
-
Ogaki-city, Gifu, Japan, 503-8502
- Novartis Investigative Site
-
-
Gunma
-
Maebashi city, Gunma, Japan, 371 8511
- Novartis Investigative Site
-
-
Hyogo
-
Amagasaki city, Hyogo, Japan, 660 8550
- Novartis Investigative Site
-
-
Ishikawa
-
Kanazawa, Ishikawa, Japan, 920 8650
- Novartis Investigative Site
-
-
Iwate
-
Morioka, Iwate, Japan, 020 0066
- Novartis Investigative Site
-
-
Kagawa
-
Kanonji-city, Kagawa, Japan, 769-1695
- Novartis Investigative Site
-
Takamatsu city, Kagawa, Japan, 760 8557
- Novartis Investigative Site
-
-
Kanagawa
-
Yokohama-city, Kanagawa, Japan, 236 0051
- Novartis Investigative Site
-
Yokohama-city, Kanagawa, Japan, 227-8501
- Novartis Investigative Site
-
-
Miyagi
-
Sendai city, Miyagi, Japan, 980 8574
- Novartis Investigative Site
-
-
Nara
-
Kashihara city, Nara, Japan, 634 8522
- Novartis Investigative Site
-
-
Saitama
-
Sayama-city, Saitama, Japan, 350-1305
- Novartis Investigative Site
-
-
Shiga
-
Kusatsu city, Shiga, Japan, 525 8585
- Novartis Investigative Site
-
-
Tokyo
-
Chiyoda-ku, Tokyo, Japan, 101-8309
- Novartis Investigative Site
-
Hachioji-city, Tokyo, Japan, 192-0918
- Novartis Investigative Site
-
Itabashi-ku, Tokyo, Japan, 173-8610
- Novartis Investigative Site
-
Shinagawa-ku, Tokyo, Japan, 142-8666
- Novartis Investigative Site
-
-
-
-
-
Haydarpasa Istanbul, Kalkun, 34668
- Novartis Investigative Site
-
Istanbul, Kalkun, 34304
- Novartis Investigative Site
-
Izmir, Kalkun, 35040
- Novartis Investigative Site
-
Izmir, Kalkun, 35340
- Novartis Investigative Site
-
Kocaeli, Kalkun, 41380
- Novartis Investigative Site
-
Pendik / Istanbul, Kalkun, 34899
- Novartis Investigative Site
-
Sivas, Kalkun, 58140
- Novartis Investigative Site
-
-
TUR
-
Istanbul, TUR, Kalkun, 34098
- Novartis Investigative Site
-
-
-
-
-
Beijing, Kina, 100029
- Novartis Investigative Site
-
Beijing, Kina, 100034
- Novartis Investigative Site
-
Chongqing, Kina, 400037
- Novartis Investigative Site
-
Jinan, Kina, 250012
- Novartis Investigative Site
-
Nanjing, Kina, 210036
- Novartis Investigative Site
-
Shanghai, Kina, 200031
- Novartis Investigative Site
-
Shanghai, Kina, 200080
- Novartis Investigative Site
-
Shanghai, Kina, 200025
- Novartis Investigative Site
-
-
Beijing
-
Beijing, Beijing, Kina, 100730
- Novartis Investigative Site
-
Beijing, Beijing, Kina, 100039
- Novartis Investigative Site
-
Beijing, Beijing, Kina, 100037
- Novartis Investigative Site
-
Beijing, Beijing, Kina, 100044
- Novartis Investigative Site
-
-
Chongqing
-
Chongqing, Chongqing, Kina, 400010
- Novartis Investigative Site
-
-
Gansu
-
Lanzhou, Gansu, Kina, 730030
- Novartis Investigative Site
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510080
- Novartis Investigative Site
-
Guangzhou, Guangdong, Kina, 51000
- Novartis Investigative Site
-
Guangzhou, Guangdong, Kina, 510515
- Novartis Investigative Site
-
-
Guangxi
-
Nanning, Guangxi, Kina, 530021
- Novartis Investigative Site
-
-
Hunan
-
Changsha, Hunan, Kina, 410003
- Novartis Investigative Site
-
-
Jiangsu
-
Nanjing, Jiangsu, Kina, 210029
- Novartis Investigative Site
-
Nanjing, Jiangsu, Kina, 210009
- Novartis Investigative Site
-
Suzhou, Jiangsu, Kina, 215004
- Novartis Investigative Site
-
Wuxi, Jiangsu, Kina
- Novartis Investigative Site
-
-
Jiangxi
-
Nanchang, Jiangxi, Kina, 330006
- Novartis Investigative Site
-
-
Jilin
-
Changchun, Jilin, Kina, 130022
- Novartis Investigative Site
-
Jilin, Jilin, Kina, 132000
- Novartis Investigative Site
-
-
Liaoning
-
Shenyang, Liaoning, Kina, 110003
- Novartis Investigative Site
-
Shenyang, Liaoning, Kina, 110016
- Novartis Investigative Site
-
-
Shanghai
-
Shanghai, Shanghai, Kina, 200032
- Novartis Investigative Site
-
Shanghai, Shanghai, Kina, 200120
- Novartis Investigative Site
-
Shanghai, Shanghai, Kina
- Novartis Investigative Site
-
-
Shanxi
-
Xi'an, Shanxi, Kina, 710032
- Novartis Investigative Site
-
Xian, Shanxi, Kina, 710061
- Novartis Investigative Site
-
-
Sichuan
-
Chengdu, Sichuan, Kina, 610041
- Novartis Investigative Site
-
-
Tianjin
-
Tianjin, Tianjin, Kina, 300121
- Novartis Investigative Site
-
-
Xinjiang
-
Wulumuqi, Xinjiang, Kina, 830054
- Novartis Investigative Site
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina, 310016
- Novartis Investigative Site
-
Hangzhou, Zhejiang, Kina, 310009
- Novartis Investigative Site
-
Hangzhou, Zhejiang, Kina, 310013
- Novartis Investigative Site
-
-
-
-
-
Daegu, Korea, Republikken, 705 718
- Novartis Investigative Site
-
Seoul, Korea, Republikken, 03080
- Novartis Investigative Site
-
Seoul, Korea, Republikken, 06351
- Novartis Investigative Site
-
Seoul, Korea, Republikken, 03722
- Novartis Investigative Site
-
Seoul, Korea, Republikken, 02841
- Novartis Investigative Site
-
-
Bucheon Si
-
Gyeonggi do, Bucheon Si, Korea, Republikken, 422-711
- Novartis Investigative Site
-
-
Chungcheongbuk Do
-
Cheongju si, Chungcheongbuk Do, Korea, Republikken, 28644
- Novartis Investigative Site
-
-
Gangwon-do
-
Wonju, Gangwon-do, Korea, Republikken, 26427
- Novartis Investigative Site
-
-
Gyeonggi Do
-
Bundang Gu, Gyeonggi Do, Korea, Republikken, 13620
- Novartis Investigative Site
-
-
KOR
-
Incheon, KOR, Korea, Republikken, 22332
- Novartis Investigative Site
-
Seoul, KOR, Korea, Republikken, 08308
- Novartis Investigative Site
-
-
Korea
-
Seoul, Korea, Korea, Republikken, 05505
- Novartis Investigative Site
-
-
-
-
-
Rijeka, Kroatien, 51000
- Novartis Investigative Site
-
Zadar, Kroatien, 23000
- Novartis Investigative Site
-
Zagreb, Kroatien, 10000
- Novartis Investigative Site
-
-
HRV
-
Varazdin, HRV, Kroatien, 42000
- Novartis Investigative Site
-
-
-
-
-
Aguascalientes, Mexico, 20230
- Novartis Investigative Site
-
Queretaro, Mexico, 76000
- Novartis Investigative Site
-
San Luis Potosi, Mexico, 78200
- Novartis Investigative Site
-
San Luis Potosí, Mexico, 78200
- Novartis Investigative Site
-
-
Coahulia
-
Torreon, Coahulia, Mexico, 27000
- Novartis Investigative Site
-
-
Distrito Federal
-
Mexico, Distrito Federal, Mexico, 14080
- Novartis Investigative Site
-
-
Guanajuato
-
Leon, Guanajuato, Mexico, 37530
- Novartis Investigative Site
-
-
Jalisco
-
Zapopan, Jalisco, Mexico, 45200
- Novartis Investigative Site
-
-
Queretaro
-
San Juan del Rio, Queretaro, Mexico, 76800
- Novartis Investigative Site
-
-
San Luis Potosí
-
San Luis Potosi, San Luis Potosí, Mexico, 78240
- Novartis Investigative Site
-
-
Sinaloa
-
Culiacan, Sinaloa, Mexico, 80230
- Novartis Investigative Site
-
-
-
-
-
Loerenskog, Norge, NO 1478
- Novartis Investigative Site
-
Oslo, Norge, 0450
- Novartis Investigative Site
-
Stavanger, Norge, 4068
- Novartis Investigative Site
-
Tromsoe, Norge, NO-9038
- Novartis Investigative Site
-
-
-
-
Lima
-
Bellavista, Lima, Peru, CALLAO 02
- Novartis Investigative Site
-
Cercado De Lima, Lima, Peru, 01
- Novartis Investigative Site
-
Jesus Maria, Lima, Peru, 11
- Novartis Investigative Site
-
Miraflores, Lima, Peru, 18
- Novartis Investigative Site
-
San Isidro, Lima, Peru, 27
- Novartis Investigative Site
-
-
-
-
-
Gdynia, Polen, 81-157
- Novartis Investigative Site
-
Gdynia, Polen, 81-548
- Novartis Investigative Site
-
Grodzisk Mazowiecki, Polen, 05 825
- Novartis Investigative Site
-
Katowice, Polen, 40-645
- Novartis Investigative Site
-
Krakow, Polen, 31 501
- Novartis Investigative Site
-
Krakow, Polen, 30-015
- Novartis Investigative Site
-
Lublin, Polen, 20-363
- Novartis Investigative Site
-
Sandomierz, Polen, 27 600
- Novartis Investigative Site
-
Staszów, Polen, 28-200
- Novartis Investigative Site
-
Torun, Polen, 87-100
- Novartis Investigative Site
-
Warszawa, Polen, 02-097
- Novartis Investigative Site
-
Warszawa, Polen, 04-154
- Novartis Investigative Site
-
Warszawa/Anin, Polen, 04-761
- Novartis Investigative Site
-
Zabrze, Polen, 41 800
- Novartis Investigative Site
-
Zamosc, Polen, 22-400
- Novartis Investigative Site
-
-
Lodzkie
-
Lodz, Lodzkie, Polen, 90 549
- Novartis Investigative Site
-
-
-
-
-
Arad, Rumænien, 310158
- Novartis Investigative Site
-
Baia Mare, Rumænien, 430222
- Novartis Investigative Site
-
Bucharest, Rumænien, 050098
- Novartis Investigative Site
-
Bucuresti, Rumænien, 062272
- Novartis Investigative Site
-
Targu Mures, Rumænien, 540142
- Novartis Investigative Site
-
Targu Mures, Rumænien, 540143
- Novartis Investigative Site
-
Timisoara, Rumænien, 300041
- Novartis Investigative Site
-
-
Arges
-
Pitesti, Arges, Rumænien, 110438
- Novartis Investigative Site
-
-
District 1
-
Bucuresti, District 1, Rumænien, 014461
- Novartis Investigative Site
-
-
Jud. Dolj
-
Craiova, Jud. Dolj, Rumænien, 200497
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Jud. Iasi
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Sibiu, Jud. Iasi, Rumænien, 550371
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Timis
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Timisoara, Timis, Rumænien, 300362
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Timisoara, Timis, Rumænien, 300125
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Basel, Schweiz, 4031
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Bern, Schweiz, 3010
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Biel, Schweiz, 2502
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Lausanne, Schweiz, 1011
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Zurich, Schweiz, 8091
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Belgrade, Serbien, 11000
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Beograd, Serbien, 11040
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Nis, Serbien, 18000
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Niska Banja, Serbien, 18205
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Singapore, Singapore, 119074
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Singapore, Singapore, 529889
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Singapore, Singapore, 308433
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Singapore, Singapore, 169609
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Singapore, Singapore, 768828
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Bardejov, Slovakiet, 085 01
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Bratislava, Slovakiet, 833 48
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Bratislava, Slovakiet, 821 07
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Bratislava, Slovakiet, 842 31
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Bratislava, Slovakiet, 841 07
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Bratislava, Slovakiet, 831 01
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Bratislava, Slovakiet, 851 01
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Kosice, Slovakiet, 040 01
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Levice, Slovakiet, 934 01
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Lucenec, Slovakiet, 98439
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Lucenec, Slovakiet, 984 01
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Nitra, Slovakiet, 949 01
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Nitra, Slovakiet, 949 88
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Nove Zamky, Slovakiet, 940 01
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Nove Zamky, Slovakiet, 94002
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Piestany, Slovakiet, 921 01
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Presov, Slovakiet, 080 01
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Svidnik, Slovakiet, 089 01
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Trebisov, Slovakiet, 075 01
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Zilina, Slovakiet, 012 07
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Slovak Republic
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Brezno, Slovak Republic, Slovakiet, 977 42
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Komarno, Slovak Republic, Slovakiet, 94501
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Levice, Slovak Republic, Slovakiet, 93401
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Namestovo, Slovak Republic, Slovakiet, 02901
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Povazska Bystrica, Slovak Republic, Slovakiet, 01701
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Presov, Slovak Republic, Slovakiet, 08001
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Golnik, Slovenien, 4204
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Ljubljana, Slovenien, 1000
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Ciudad Real, Spanien, 13005
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Madrid, Spanien, 28034
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Madrid, Spanien, 28046
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Madrid, Spanien, 28040
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Madrid, Spanien, 28009
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Madrid, Spanien, 28222
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Andalucia
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Almeria, Andalucia, Spanien, 04120
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Cordoba, Andalucia, Spanien, 14004
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Malaga, Andalucia, Spanien, 29010
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Marbella, Andalucia, Spanien, 29600
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Sanlúcar de Barrameda, Andalucia, Spanien, 11540
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Sevilla, Andalucia, Spanien, 41013
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Sevilla, Andalucia, Spanien, 41014
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Barcelona
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Sant Joan Despi, Barcelona, Spanien, 08970
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Cadiz
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Villamartin, Cadiz, Spanien, 11650
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Cantabria
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Santander, Cantabria, Spanien, 39008
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Castilla Y Leon
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Aranda de Duero, Castilla Y Leon, Spanien, 09400
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Leon, Castilla Y Leon, Spanien, 24071
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Cataluna
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Lerida, Cataluna, Spanien, 25198
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Catalunya
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Badalona, Catalunya, Spanien, 08916
- Novartis Investigative Site
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Barcelona, Catalunya, Spanien, 08003
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Comunidad Valenciana
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Alzira, Comunidad Valenciana, Spanien, 46600
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Valencia, Comunidad Valenciana, Spanien, 46014
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Valencia, Comunidad Valenciana, Spanien, 46026
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Valencia, Comunidad Valenciana, Spanien, 46010
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Extremadura
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Merida, Extremadura, Spanien, 06800
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Galicia
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A Coruna, Galicia, Spanien, 15006
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Santiago de Compostela, Galicia, Spanien, 15706
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Girona
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Olot, Girona, Spanien, 17800
- Novartis Investigative Site
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Madrid
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Mostoles, Madrid, Spanien, 28935
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Murcia
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El Palmar, Murcia, Spanien, 30120
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Danderyd, Sverige, 182 88
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Falun, Sverige, 791 82
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Goteborg, Sverige, 413 45
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Karlstad, Sverige, 652 30
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Lund, Sverige, 222 21
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Orebro, Sverige, 701 85
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Stockholm, Sverige, 17176
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Vasteras, Sverige, 72189
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Alberton, Sydafrika, 1449
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Bloemfontein, Sydafrika, 9301
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Cape Town, Sydafrika, 7500
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Cape Town, Sydafrika, 7531
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Cape Town, Sydafrika, 7925
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Durban, Sydafrika, 4001
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Tongaat, Sydafrika, 3300
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Western Cape, Sydafrika, 7130
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Worcester, Sydafrika, 6850
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Free State
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Bloemfontein, Free State, Sydafrika, 9301
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Gauteng
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Soweto, Gauteng, Sydafrika, 2013
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Kwa-Zulu Natal
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Durban, Kwa-Zulu Natal, Sydafrika, 4052
- Novartis Investigative Site
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Changhua, Taiwan, 50006
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Kaohsiung, Taiwan, 80756
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New Taipei, Taiwan, 22060
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Taichung, Taiwan, 40447
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Tainan, Taiwan, 71004
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Taipei, Taiwan, 10002
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Taipei, Taiwan, 11217
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Yilan, Taiwan, 26058
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Taiwan ROC
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Tainan, Taiwan ROC, Taiwan, 70403
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CZE, Tjekkiet, 11000
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Kolin, Tjekkiet, 280 20
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Marianske lazne, Tjekkiet, 353 01
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Uherske Hradiste, Tjekkiet, 68601
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CZE
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Policska, CZE, Tjekkiet, 57201
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Praha 2, CZE, Tjekkiet, 128 08
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Usti nad Labem, CZE, Tjekkiet, 400 01
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Czech Republic
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Brandys nad Labem, Czech Republic, Tjekkiet, 250 01
- Novartis Investigative Site
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Brno, Czech Republic, Tjekkiet, 60200
- Novartis Investigative Site
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Ivancice, Czech Republic, Tjekkiet, 66491
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Kladno, Czech Republic, Tjekkiet, 272 80
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Liberec, Czech Republic, Tjekkiet, 460 05
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Louny, Czech Republic, Tjekkiet
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Ostrava, Czech Republic, Tjekkiet, 70200
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Plzen, Czech Republic, Tjekkiet, 30100
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Praha 4, Czech Republic, Tjekkiet, 140 21
- Novartis Investigative Site
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Roznov pod Radhostem, Czech Republic, Tjekkiet, 756 61
- Novartis Investigative Site
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Svitavy, Czech Republic, Tjekkiet, 568 25
- Novartis Investigative Site
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Trebic, Czech Republic, Tjekkiet, 674 01
- Novartis Investigative Site
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Usti nad Labem, Czech Republic, Tjekkiet, 400 01
- Novartis Investigative Site
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Znojmo, Czech Republic, Tjekkiet, 66902
- Novartis Investigative Site
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Aachen, Tyskland, 52074
- Novartis Investigative Site
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Bad Homburg, Tyskland, 61348
- Novartis Investigative Site
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Bad Krozingen, Tyskland, 79189
- Novartis Investigative Site
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Bamberg, Tyskland, 96049
- Novartis Investigative Site
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Berlin, Tyskland, 13086
- Novartis Investigative Site
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Berlin, Tyskland, 13353
- Novartis Investigative Site
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Berlin, Tyskland, 10789
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Berlin, Tyskland, 12157
- Novartis Investigative Site
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Berlin, Tyskland, 12683
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Berlin, Tyskland, 13405
- Novartis Investigative Site
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Berlin Buch, Tyskland, 13125
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Chemnitz, Tyskland, 09130
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Chemnitz, Tyskland, 09126
- Novartis Investigative Site
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Dessau-Roßlau, Tyskland, 06846
- Novartis Investigative Site
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Dresden, Tyskland, 01307
- Novartis Investigative Site
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Dresden, Tyskland, 01277
- Novartis Investigative Site
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Dresden, Tyskland, 01309
- Novartis Investigative Site
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Duisburg, Tyskland, 47137
- Novartis Investigative Site
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Eilenburg, Tyskland, D 04838
- Novartis Investigative Site
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Elsterwerda, Tyskland, 04910
- Novartis Investigative Site
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Essen, Tyskland, 45355
- Novartis Investigative Site
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Frankfurt, Tyskland, 60594
- Novartis Investigative Site
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Frankfurt, Tyskland, 65929
- Novartis Investigative Site
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Hamburg, Tyskland, 20246
- Novartis Investigative Site
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Hamburg, Tyskland, 20099
- Novartis Investigative Site
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Hamburg, Tyskland, 22041
- Novartis Investigative Site
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Hamburg, Tyskland, 22765
- Novartis Investigative Site
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Hassloch, Tyskland, 67454
- Novartis Investigative Site
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Heidenau, Tyskland, 01809
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Heppenheim, Tyskland, 64646
- Novartis Investigative Site
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Homburg, Tyskland, 66421
- Novartis Investigative Site
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Ingelheim, Tyskland, 55218
- Novartis Investigative Site
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Jena, Tyskland, 07740
- Novartis Investigative Site
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Kassel, Tyskland, 34121
- Novartis Investigative Site
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Kleve, Tyskland, 47533
- Novartis Investigative Site
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Koblenz, Tyskland, 56068
- Novartis Investigative Site
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Koeln, Tyskland, 51065
- Novartis Investigative Site
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Leipzig, Tyskland, 04103
- Novartis Investigative Site
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Loehne, Tyskland, 32584
- Novartis Investigative Site
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Ludwigshafen, Tyskland, 67071
- Novartis Investigative Site
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Lutherstadt Wittenberg, Tyskland, 06886
- Novartis Investigative Site
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Lüneburg, Tyskland, 21339
- Novartis Investigative Site
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Mainz, Tyskland, 55116
- Novartis Investigative Site
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Meißen, Tyskland, 01662
- Novartis Investigative Site
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Memmingen, Tyskland, 87700
- Novartis Investigative Site
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Muehldorf, Tyskland, 84453
- Novartis Investigative Site
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Muehldorf Am Inn, Tyskland, 84453
- Novartis Investigative Site
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Muenster, Tyskland, 48149
- Novartis Investigative Site
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Munchen, Tyskland, 81675
- Novartis Investigative Site
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Munich, Tyskland, 80638
- Novartis Investigative Site
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Nienburg, Tyskland, 31582
- Novartis Investigative Site
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Northeim, Tyskland, 37154
- Novartis Investigative Site
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Oschatz, Tyskland, 04758
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Papenburg, Tyskland, 26871
- Novartis Investigative Site
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Reinfeld, Tyskland, 23858
- Novartis Investigative Site
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Riesa, Tyskland, 01589
- Novartis Investigative Site
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Rodgau, Tyskland, 63110
- Novartis Investigative Site
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Siegen, Tyskland, 57072
- Novartis Investigative Site
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Ulm, Tyskland, 89077
- Novartis Investigative Site
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Wermsdorf, Tyskland, 04779
- Novartis Investigative Site
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Weyhe, Tyskland, 28844
- Novartis Investigative Site
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Witten, Tyskland, 58455
- Novartis Investigative Site
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Wuerzburg, Tyskland, 97080
- Novartis Investigative Site
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Sachsen
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Dresden, Sachsen, Tyskland, 01099
- Novartis Investigative Site
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Budapest, Ungarn, 1145
- Novartis Investigative Site
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Budapest, Ungarn, 1085
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Budapest, Ungarn, 1134
- Novartis Investigative Site
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Budapest, Ungarn, H 1096
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Budapest, Ungarn, 1042
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Cegled, Ungarn, 2700
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Kistarcsa, Ungarn, 2143
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Mako, Ungarn, 6900
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Nyiregyháza, Ungarn, 4400
- Novartis Investigative Site
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Pecs, Ungarn, 7635
- Novartis Investigative Site
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Pecs, Ungarn, 7623
- Novartis Investigative Site
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Pécs, Ungarn, 7623
- Novartis Investigative Site
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Szeged, Ungarn, H 6725
- Novartis Investigative Site
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Szekesfehervar, Ungarn, H-8000
- Novartis Investigative Site
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Zala
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Zalaegerszeg, Zala, Ungarn, 8900
- Novartis Investigative Site
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Braunau, Østrig, A5280
- Novartis Investigative Site
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Graz, Østrig, A-8036
- Novartis Investigative Site
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Graz, Østrig, 8020
- Novartis Investigative Site
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Großgmain, Østrig, 5084
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Linz, Østrig, 4010
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Vienna, Østrig, 1130
- Novartis Investigative Site
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Wien, Østrig, A 1090
- Novartis Investigative Site
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Tyrol
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Innsbruck, Tyrol, Østrig, 6020
- Novartis Investigative Site
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inklusionskriterier:
- Venstre ventrikulær ejektionsfraktion (LVEF) ≥45 % ved ekko under screeningsepoken eller inden for 6 måneder før studiestart.
- Symptomer på hjertesvigt (HF) og som kræver behandling med diuretika for HF mindst 30 dage før studiestart.
- Aktuelle symptom(er) på HF (NYHA klasse II-IV)
- Strukturel hjertesygdom (forstørrelse af venstre forkammer eller hypertrofi i venstre ventrikel) dokumenteret ved ekkokardiogram.
- Forhøjet NT-proBNP
Ekskluderingskriterier:
- Enhver tidligere måling af LVEF < 40 %.
- Akut koronarsyndrom (inklusive MI), hjertekirurgi, anden større CV-operation inden for 3 måneder eller akut perkutan koronar intervention inden for 3 måneder eller og elektiv PCI inden for 30 dage før indrejse.
- Enhver klinisk hændelse inden for de 6 måneder forud for indtræden kunne have reduceret LVEF (f.eks. MI, CABG), medmindre en ekkomåling udført efter hændelsen bekræfter en LVEF ≥45 %.
- Aktuel akut dekompenseret HF, der kræver terapi.
- Patienter, der har behov for behandling med 2 eller flere af følgende: en angiotensinkonverterende enzymhæmmer (ACEI), en angiotensinreceptorblokker (ARB) eller en reninhæmmer.
- Alternativ årsag til åndenød såsom: betydelig lungesygdom eller svær KOL, hæmoglobin (Hgb) <10 g/dl eller body mass index (BMI) > 40 kg/m2.
- Systolisk blodtryk (SBP) ≥ 180 mmHg ved indtræden eller SBP >150 mmHg og <180 mmHg ved indtræden, medmindre patienten får 3 eller flere antihypertensiva, eller SBP < 110 mmHg ved indtræden.
Andre protokoldefinerede inklusions-/udelukkelseskriterier kan være gældende.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: LCZ696
Enkelt blind indkøringsperiode (3-8 uger): Patienterne vil begynde på Valsartan 80 mg b.i.d. i 1-2 uger efterfulgt af LCZ696 100 mg b.i.d. i 2-4 uger før randomisering til den dobbeltblindede periode (op til 57 måneder).
Patienter kan kun randomiseres fra indkøringsperioden, hvis de opfylder alle indkøringssikkerhedskriterierne.
Måldosis af LCZ696 i den dobbeltblindede periode er 200 mg b.i.d.
|
LCZ696 50 mg, 100 mg og 200 mg dosisstyrker vil være tilgængelig for dosisjusteringer.
|
|
Aktiv komparator: Valsartan
Enkelt blind indkøringsperiode (3-8 uger): Patienterne vil begynde på Valsartan 80 mg b.i.d. i 1-2 uger efterfulgt af LCZ696 100 mg b.i.d. i 2-4 uger før randomisering til den dobbeltblindede periode (op til 57 måneder).
Patienter kan kun randomiseres fra indkøringsperioden, hvis de opfylder alle indkøringssikkerhedskriterierne.
Måldosis af Valsartan i den dobbeltblindede periode er 160 mg b.i.d.
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Valsartan 40 mg, 80 mg og 160 mg dosisstyrker vil være tilgængelige for dosisjusteringer.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Kumulativt antal primære sammensatte hændelser af kardiovaskulær (CV) død og samlede (første og tilbagevendende) HF-indlæggelser.
Tidsramme: Samlet opfølgningstid (op til 57 måneder)
|
Det primære formål med denne undersøgelse er at sammenligne LCZ696 med valsartan for at reducere frekvensen af det sammensatte endepunkt for CV-død og totale (første og tilbagevendende) HF-indlæggelser hos HF-patienter (New York Heart Association [NYHA] Klasse II-IV) med bevaret ejektionsfraktion (venstre ventrikulær ejektionsfraktion [LVEF] ≥45%).
Behandlingsarmen med den laveste frekvens af hændelser vil blive anset for at have et vellykket respons.
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Samlet opfølgningstid (op til 57 måneder)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Ændring i den kliniske opsummeringsscore fra baseline til måned 8 af Kansas City Cardiomyopathy Questionnaire (KCCQ)
Tidsramme: Baseline, 8 måneder
|
KCCQ er et valideret instrument til selvevaluering af livskvalitet og helbredsstatus hos patienter med hjertesvigt (HF).
Den kliniske opsummeringsscore, som er afledt af domænerne fysiske begrænsninger og hjertesvigt (HF)-symptomer i KCCQ, er et validt mål til at vurdere patientens helbredsaspekter, som kan være påvirket af CV-medicin.
Scores omdannes til et interval på 0-100, hvor højere score afspejler bedre sundhedstilstand.
Evaluering af ændring fra baseline til måned 8 i KCCQ, et meget følsomt, specifikt og responsivt sundhedsrelateret livskvalitetsmål for hjertesvigtssymptomer og fysiske begrænsninger.
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Baseline, 8 måneder
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Skift fra baseline til måned 8 i New York Heart Association (NYHA) funktionsklasse
Tidsramme: Baseline, 8 måneder
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Evaluering af ændring fra baseline til måned 8 i NYHA funktionsklasse, en veletableret karakterskala, der bruges til at klassificere en hjertesvigts (HF) patienters funktionsniveau baseret på de tegn og symptomer på HF, som patienten udviser.
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Baseline, 8 måneder
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Deltagere med første forekomst af et sammensat nyreendepunkt
Tidsramme: Randomisering til samlet opfølgningstid (op til 57 måneder)
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Analyse af sammensat nyreendepunkt defineret som nyredød eller opnåelse af ESRD eller ≥50 % fald i eGFR i forhold til baseline, ved brug af Cox's proportional hazards model.
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Randomisering til samlet opfølgningstid (op til 57 måneder)
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Dødelighed af alle årsager
Tidsramme: Randomisering til samlet opfølgningstid (op til 57 måneder)
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Analyse for dødelighed af alle årsager ved hjælp af Cox's model for proportional hazards.
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Randomisering til samlet opfølgningstid (op til 57 måneder)
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Publikationer og nyttige links
Generelle publikationer
- Butt JH, Dewan P, Jhund PS, Anand IS, Atar D, Ge J, Desai AS, Echeverria LE, Kober L, Lam CSP, Maggioni AP, Martinez F, Packer M, Rouleau JL, Sim D, Van Veldhuisen DJ, Vrtovec B, Zannad F, Zile MR, Gong J, Lefkowitz MP, Rizkala AR, Solomon SD, McMurray JJV. Sacubitril/Valsartan and Frailty in Patients With Heart Failure and Preserved Ejection Fraction. J Am Coll Cardiol. 2022 Sep 20;80(12):1130-1143. doi: 10.1016/j.jacc.2022.06.037. Epub 2022 Aug 29.
- Wijkman MO, Claggett B, Vaduganathan M, Cunningham JW, Rørth R, Jackson A, Packer M, Zile M, Rouleau J, Swedberg K, Lefkowitz M, Shah SJ, Pfeffer MA, McMurray JJV, Solomon SD. Effects of sacubitril/valsartan on glycemia in patients with diabetes and heart failure: the PARAGON-HF and PARADIGM-HF trials. Cardiovasc Diabetol. 2022 Jun 18;21(1):110. doi: 10.1186/s12933-022-01545-1.
- Vaduganathan M, Claggett BL, Inciardi RM, Fonarow GC, McMurray JJV, Solomon SD. Estimating the Benefits of Combination Medical Therapy in Heart Failure With Mildly Reduced and Preserved Ejection Fraction. Circulation. 2022 Jun 7;145(23):1741-1743. doi: 10.1161/CIRCULATIONAHA.121.058929. Epub 2022 May 23. No abstract available.
- Vaduganathan M, Claggett BL, McMurray JJV, Solomon SD. Health Status Trajectories Before and After Hospitalization for Heart Failure. Circulation. 2022 Jun 21;145(25):1872-1874. doi: 10.1161/CIRCULATIONAHA.122.059282. Epub 2022 May 21. No abstract available.
- Cikes M, Planinc I, Claggett B, Cunningham J, Milicic D, Sweitzer N, Senni M, Gori M, Linssen G, Shah SJ, Packer M, Pfeffer M, Zile MR, Anand I, Chiang LM, Lam CSP, Redfield M, Desai AS, McMurray JJV, Solomon SD. Atrial Fibrillation in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial. JACC Heart Fail. 2022 May;10(5):336-346. doi: 10.1016/j.jchf.2022.01.018. Epub 2022 Apr 6.
- Jackson AM, Rorth R, Liu J, Kristensen SL, Anand IS, Claggett BL, Cleland JGF, Chopra VK, Desai AS, Ge J, Gong J, Lam CSP, Lefkowitz MP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rizkala AR, Rouleau JL, Seferovic PM, Tromp J, Van Veldhuisen DJ, Yilmaz MB, Zannad F, Zile MR, Kober L, Petrie MC, Jhund PS, Solomon SD, McMurray JJV; PARAGON-HF Committees and Investigators. Diabetes and pre-diabetes in patients with heart failure and preserved ejection fraction. Eur J Heart Fail. 2022 Mar;24(3):497-509. doi: 10.1002/ejhf.2403. Epub 2022 Jan 4.
- Desai AS, Vaduganathan M, Cleland JG, Claggett BL, Barkoudah E, Finn P, McCausland FR, Yilmaz MB, Lefkowitz M, Shi V, Pfeffer MA, McMurray JJV, Solomon SD. Mode of Death in Patients With Heart Failure and Preserved Ejection Fraction: Insights From PARAGON-HF Trial. Circ Heart Fail. 2021 Dec;14(12):e008597. doi: 10.1161/CIRCHEARTFAILURE.121.008597. Epub 2021 Nov 22.
- Mooney L, Hawkins NM, Jhund PS, Redfield MM, Vaduganathan M, Desai AS, Rouleau JL, Minamisawa M, Shah AM, Lefkowitz MP, Zile MR, Van Veldhuisen DJ, Pfeffer MA, Anand IS, Maggioni AP, Senni M, Claggett BL, Solomon SD, McMurray JJV. Impact of Chronic Obstructive Pulmonary Disease in Patients With Heart Failure With Preserved Ejection Fraction: Insights From PARAGON-HF. J Am Heart Assoc. 2021 Dec 7;10(23):e021494. doi: 10.1161/JAHA.121.021494. Epub 2021 Nov 19.
- Jackson AM, Jhund PS, Anand IS, Dungen HD, Lam CSP, Lefkowitz MP, Linssen G, Lund LH, Maggioni AP, Pfeffer MA, Rouleau JL, Saraiva JFK, Senni M, Vardeny O, Wijkman MO, Yilmaz MB, Saito Y, Zile MR, Solomon SD, McMurray JJV. Sacubitril-valsartan as a treatment for apparent resistant hypertension in patients with heart failure and preserved ejection fraction. Eur Heart J. 2021 Sep 21;42(36):3741-3752. doi: 10.1093/eurheartj/ehab499.
- Felker GM, Butler J, Januzzi JL Jr, Desai AS, McMurray JJV, Solomon SD. Probabilistic Readjudication of Heart Failure Hospitalization Events in the PARAGON-HF Study. Circulation. 2021 Jun 8;143(23):2316-2318. doi: 10.1161/CIRCULATIONAHA.121.054496. Epub 2021 Jun 7. No abstract available.
- Selvaraj S, Claggett BL, Packer M, Zannad F, Anand IS, Pieske B, Zhao Z, Shi VC, Lefkowitz MP, McMurray JJV, Solomon SD. Effects of Sacubitril/Valsartan on Serum Lipids in Heart Failure With Preserved Ejection Fraction. J Am Heart Assoc. 2021 Sep 7;10(17):e022069. doi: 10.1161/JAHA.121.022069. Epub 2021 May 16.
- Shen L, Jhund PS, Anand IS, Bhatt AS, Desai AS, Maggioni AP, Martinez FA, Pfeffer MA, Rizkala AR, Rouleau JL, Swedberg K, Vaduganathan M, Vardeny O, van Veldhuisen DJ, Zannad F, Zile MR, Packer M, Solomon SD, McMurray JJV. Incidence and Outcomes of Pneumonia in Patients With Heart Failure. J Am Coll Cardiol. 2021 Apr 27;77(16):1961-1973. doi: 10.1016/j.jacc.2021.03.001.
- Tromp J, Claggett BL, Liu J, Jackson AM, Jhund PS, Kober L, Widimsky J, Boytsov SA, Chopra VK, Anand IS, Ge J, Chen CH, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, Van Veldhuisen DJ, Zannad F, Zile MR, Rizkala AR, Inubushi-Molessa A, Lefkowitz MP, Shi VC, McMurray JJV, Solomon SD, Lam CSP; PARAGON-HF Investigators. Global Differences in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial. Circ Heart Fail. 2021 Apr;14(4):e007901. doi: 10.1161/CIRCHEARTFAILURE.120.007901. Epub 2021 Apr 19.
- Vaduganathan M, Cunningham JW, Claggett BL, Causland FM, Barkoudah E, Finn P, Zannad F, Pfeffer MA, Rizkala AR, Sabarwal S, McMurray JJV, Solomon S, Desai AS. Worsening Heart Failure Episodes Outside a Hospital Setting in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial. JACC Heart Fail. 2021 May;9(5):374-382. doi: 10.1016/j.jchf.2021.01.014. Epub 2021 Apr 7.
- Gronda E, Vanoli E, Iacoviello M. The PARAGON-HF trial: the sacubitril/valsartan in heart failure with preserved ejection fraction. Eur Heart J Suppl. 2020 Nov 18;22(Suppl L):L77-L81. doi: 10.1093/eurheartj/suaa140. eCollection 2020 Nov.
- Jering K, Claggett B, Redfield MM, Shah SJ, Anand IS, Martinez F, Sabarwal SV, Seferovic PM, Kerr Saraiva JF, Katova T, Lefkowitz MP, Pfeffer MA, McMurray JJV, Solomon SD. Burden of Heart Failure Signs and Symptoms, Prognosis, and Response to Therapy: The PARAGON-HF Trial. JACC Heart Fail. 2021 May;9(5):386-397. doi: 10.1016/j.jchf.2021.01.011. Epub 2021 Mar 10.
- Jering KS, Zannad F, Claggett B, Mc Causland FR, Ferreira JP, Desai A, Barkoudah E, McMurray JJV, Pfeffer MA, Solomon SD. Cardiovascular and Renal Outcomes of Mineralocorticoid Receptor Antagonist Use in PARAGON-HF. JACC Heart Fail. 2021 Jan;9(1):13-24. doi: 10.1016/j.jchf.2020.08.014. Epub 2020 Nov 11.
- Mc Causland FR, Lefkowitz MP, Claggett B, Anavekar NS, Senni M, Gori M, Jhund PS, McGrath MM, Packer M, Shi V, Van Veldhuisen DJ, Zannad F, Comin-Colet J, Pfeffer MA, McMurray JJV, Solomon SD. Angiotensin-Neprilysin Inhibition and Renal Outcomes in Heart Failure With Preserved Ejection Fraction. Circulation. 2020 Sep 29;142(13):1236-1245. doi: 10.1161/CIRCULATIONAHA.120.047643. Epub 2020 Aug 17.
- Cunningham JW, Claggett BL, O'Meara E, Prescott MF, Pfeffer MA, Shah SJ, Redfield MM, Zannad F, Chiang LM, Rizkala AR, Shi VC, Lefkowitz MP, Rouleau J, McMurray JJV, Solomon SD, Zile MR. Effect of Sacubitril/Valsartan on Biomarkers of Extracellular Matrix Regulation in Patients With HFpEF. J Am Coll Cardiol. 2020 Aug 4;76(5):503-514. doi: 10.1016/j.jacc.2020.05.072.
- Cunningham JW, Vaduganathan M, Claggett BL, Zile MR, Anand IS, Packer M, Zannad F, Lam CSP, Janssens S, Jhund PS, Kober L, Rouleau J, Shah SJ, Chopra VK, Shi VC, Lefkowitz MP, Prescott MF, Pfeffer MA, McMurray JJV, Solomon SD. Effects of Sacubitril/Valsartan on N-Terminal Pro-B-Type Natriuretic Peptide in Heart Failure With Preserved Ejection Fraction. JACC Heart Fail. 2020 May;8(5):372-381. doi: 10.1016/j.jchf.2020.03.002. Epub 2020 Mar 30.
- Selvaraj S, Claggett BL, Bohm M, Anker SD, Vaduganathan M, Zannad F, Pieske B, Lam CSP, Anand IS, Shi VC, Lefkowitz MP, McMurray JJV, Solomon SD. Systolic Blood Pressure in Heart Failure With Preserved Ejection Fraction Treated With Sacubitril/Valsartan. J Am Coll Cardiol. 2020 Apr 14;75(14):1644-1656. doi: 10.1016/j.jacc.2020.02.009. Epub 2020 Mar 16.
- Shah AM, Cikes M, Prasad N, Li G, Getchevski S, Claggett B, Rizkala A, Lukashevich I, O'Meara E, Ryan JJ, Shah SJ, Mullens W, Zile MR, Lam CSP, McMurray JJV, Solomon SD; PARAGON-HF Investigators. Echocardiographic Features of Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction. J Am Coll Cardiol. 2019 Dec 10;74(23):2858-2873. doi: 10.1016/j.jacc.2019.09.063.
- Solomon SD, Vaduganathan M, L Claggett B, Packer M, Zile M, Swedberg K, Rouleau J, A Pfeffer M, Desai A, Lund LH, Kober L, Anand I, Sweitzer N, Linssen G, Merkely B, Luis Arango J, Vinereanu D, Chen CH, Senni M, Sibulo A, Boytsov S, Shi V, Rizkala A, Lefkowitz M, McMurray JJV. Sacubitril/Valsartan Across the Spectrum of Ejection Fraction in Heart Failure. Circulation. 2020 Feb 4;141(5):352-361. doi: 10.1161/CIRCULATIONAHA.119.044586. Epub 2019 Nov 17.
- McMurray JJV, Jackson AM, Lam CSP, Redfield MM, Anand IS, Ge J, Lefkowitz MP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Rizkala AR, Sabarwal SV, Shah AM, Shah SJ, Shi VC, van Veldhuisen DJ, Zannad F, Zile MR, Cikes M, Goncalvesova E, Katova T, Kosztin A, Lelonek M, Sweitzer N, Vardeny O, Claggett B, Jhund PS, Solomon SD. Effects of Sacubitril-Valsartan Versus Valsartan in Women Compared With Men With Heart Failure and Preserved Ejection Fraction: Insights From PARAGON-HF. Circulation. 2020 Feb 4;141(5):338-351. doi: 10.1161/CIRCULATIONAHA.119.044491. Epub 2019 Nov 17.
- Vaduganathan M, Claggett BL, Desai AS, Anker SD, Perrone SV, Janssens S, Milicic D, Arango JL, Packer M, Shi VC, Lefkowitz MP, McMurray JJV, Solomon SD. Prior Heart Failure Hospitalization, Clinical Outcomes, and Response to Sacubitril/Valsartan Compared With Valsartan in HFpEF. J Am Coll Cardiol. 2020 Jan 28;75(3):245-254. doi: 10.1016/j.jacc.2019.11.003. Epub 2019 Nov 11.
- Solomon SD, McMurray JJV, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, van Veldhuisen DJ, Zannad F, Zile MR, Desai AS, Claggett B, Jhund PS, Boytsov SA, Comin-Colet J, Cleland J, Dungen HD, Goncalvesova E, Katova T, Kerr Saraiva JF, Lelonek M, Merkely B, Senni M, Shah SJ, Zhou J, Rizkala AR, Gong J, Shi VC, Lefkowitz MP; PARAGON-HF Investigators and Committees. Angiotensin-Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction. N Engl J Med. 2019 Oct 24;381(17):1609-1620. doi: 10.1056/NEJMoa1908655. Epub 2019 Sep 1.
- Chandra A, Vaduganathan M, Lewis EF, Claggett BL, Rizkala AR, Wang W, Lefkowitz MP, Shi VC, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, Van Veldhuisen DJ, Zannad F, Zile MR, McMurray JJV, Solomon SD; PARAGON-HF Investigators. Health-Related Quality of Life in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial. JACC Heart Fail. 2019 Oct;7(10):862-874. doi: 10.1016/j.jchf.2019.05.015. Epub 2019 Jul 10.
- Solomon SD, Rizkala AR, Lefkowitz MP, Shi VC, Gong J, Anavekar N, Anker SD, Arango JL, Arenas JL, Atar D, Ben-Gal T, Boytsov SA, Chen CH, Chopra VK, Cleland J, Comin-Colet J, Duengen HD, Echeverria Correa LE, Filippatos G, Flammer AJ, Galinier M, Godoy A, Goncalvesova E, Janssens S, Katova T, Kober L, Lelonek M, Linssen G, Lund LH, O'Meara E, Merkely B, Milicic D, Oh BH, Perrone SV, Ranjith N, Saito Y, Saraiva JF, Shah S, Seferovic PM, Senni M, Sibulo AS Jr, Sim D, Sweitzer NK, Taurio J, Vinereanu D, Vrtovec B, Widimsky J Jr, Yilmaz MB, Zhou J, Zweiker R, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, Van Veldhuisen DJ, Zannad F, Zile MR, McMurray JJV. Baseline Characteristics of Patients With Heart Failure and Preserved Ejection Fraction in the PARAGON-HF Trial. Circ Heart Fail. 2018 Jul;11(7):e004962. doi: 10.1161/CIRCHEARTFAILURE.118.004962.
- Mutze T, Glimm E, Schmidli H, Friede T. Group sequential designs with robust semiparametric recurrent event models. Stat Methods Med Res. 2019 Aug;28(8):2385-2403. doi: 10.1177/0962280218780538. Epub 2018 Jun 11.
- Solomon SD, Rizkala AR, Gong J, Wang W, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, Van Veldhuisen DJ, Zannad F, Zile MR, Desai AS, Shi VC, Lefkowitz MP, McMurray JJV. Angiotensin Receptor Neprilysin Inhibition in Heart Failure With Preserved Ejection Fraction: Rationale and Design of the PARAGON-HF Trial. JACC Heart Fail. 2017 Jul;5(7):471-482. doi: 10.1016/j.jchf.2017.04.013. Epub 2017 Jun 26.
- Rossi A, Gheorghiade M, Triposkiadis F, Solomon SD, Pieske B, Butler J. Left atrium in heart failure with preserved ejection fraction: structure, function, and significance. Circ Heart Fail. 2014 Nov;7(6):1042-9. doi: 10.1161/CIRCHEARTFAILURE.114.001276. No abstract available.
Datoer for undersøgelser
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Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CLCZ696D2301
- 2013-001747-31 (EudraCT nummer)
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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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