Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints (Core and Extension Phases) (ALTITUDE)

April 1, 2014 updated by: Novartis Pharmaceuticals

A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Determine Whether, in Patients With Type 2 Diabetes at High Risk for Cardiovascular and Renal Events, Aliskiren, on Top of Conventional Treatment, Reduces Cardiovascular and Renal Morbidity and Mortality

The purpose of this study was to determine whether, in patients with type 2 diabetes and pre-existing disease of the heart and the circulatory system and/or the kidney, aliskiren at a target dose of 300 mg once daily (compared to placebo), on top of conventional treatment, reduces death and disease caused by the heart, the circulatory system and the kidney.

AMENDMENT 4 RATIONALE (MARCH 2012) :

Protocol amendment 4 served to address the data monitoring committee recommendation dated 14 Dec 2011 to discontinue study treatment in all participating patients. It also addressed the subsequent Health Authorities request to implement a 12 month safety follow-up period (actual duration was 9 months in average) post study drug discontinuation.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8606

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
      • Buenos Aires, Argentina, C1405BCH
        • Novartis Investigative Site
      • Buenos aires, Argentina, C1120AAC
        • Novartis Investigative Site
      • Cordoba, Argentina, X5016KEH
        • Novartis Investigative Site
      • Cordoba, Argentina, X5000JHQ
        • Novartis Investigative Site
      • Cordoba, Argentina, X5009BSN
        • Novartis Investigative Site
      • Cordoba, Argentina, X5000AAW
        • Novartis Investigative Site
      • Cordoba, Argentina, X5000EVQ
        • Novartis Investigative Site
      • Cordoba, Argentina, 5000
        • Novartis Investigative Site
      • Cordoba, Argentina, X5000FGG
        • Novartis Investigative Site
      • Cordoba, Argentina, X5000IUG
        • Novartis Investigative Site
      • Corrientes, Argentina, W3400
        • Novartis Investigative Site
      • Santa Fe, Argentina, S3000FNF
        • Novartis Investigative Site
      • Santa Fe, Argentina, S3000FSO
        • Novartis Investigative Site
      • Santa Fe, Argentina, S3000FVA
        • Novartis Investigative Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1280AEB
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1181ACH
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, 1428
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1408INH
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1416DRJ
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1425AST
        • Novartis Investigative Site
      • Florida, Buenos Aires, Argentina, B1602BPD
        • Novartis Investigative Site
      • Lanus, Buenos Aires, Argentina, B8000XAV
        • Novartis Investigative Site
      • Ramos Mejia, Buenos Aires, Argentina, B1704ETD
        • Novartis Investigative Site
      • Zarate, Buenos Aires, Argentina, 2800
        • Novartis Investigative Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000CXH
        • Novartis Investigative Site
      • Rosario, Santa Fe, Argentina, S2000AII
        • Novartis Investigative Site
      • Rosario, Santa Fe, Argentina, S200CVD
        • Novartis Investigative Site
      • Rosario, Santa Fe, Argentina, S2001ODA
        • Novartis Investigative Site
      • Rosario, Santa Fe, Argentina, S2000DFD
        • Novartis Investigative Site
  • Austria
      • Bregenz, Austria, A-6900
        • Novartis Investigative Site
      • Feldkirch, Austria, 6807
        • Novartis Investigative Site
      • Graz, Austria, 8036
        • Novartis Investigative Site
      • Innsbruck, Austria, INNSBRUCK
        • Novartis Investigative Site
      • Salzburg, Austria, A-5020
        • Novartis Investigative Site
      • Vienna, Austria, 1030
        • Novartis Investigative Site
      • Wien, Austria, 1090
        • Novartis Investigative Site
      • Wien, Austria, A-1220
        • Novartis Investigative Site
      • Wien, Austria, A-1130
        • Novartis Investigative Site
  • Belgium
      • Bonheiden, Belgium, 2820
        • Novartis Investigative Site
      • Brugge, Belgium, 8000
        • Novartis Investigative Site
      • Brussel, Belgium, 9100
        • Novartis Investigative Site
      • Bruxelles, Belgium, 1200
        • Novartis Investigative Site
      • Bruxelles, Belgium, 1070
        • Novartis Investigative Site
      • Charleroi, Belgium, 6000
        • Novartis Investigative Site
      • De Pinte, Belgium, 9840
        • Novartis Investigative Site
      • Edegem, Belgium, 2650
        • Novartis Investigative Site
      • Genk, Belgium, 3600
        • Novartis Investigative Site
      • Gent, Belgium, 9000
        • Novartis Investigative Site
      • Hasselt, Belgium, 3500
        • Novartis Investigative Site
      • Kortrijk, Belgium, 8500
        • Novartis Investigative Site
      • La Louvière, Belgium, 7100
        • Novartis Investigative Site
      • Leuven, Belgium, 3000
        • Novartis Investigative Site
      • Liege, Belgium, 4000
        • Novartis Investigative Site
      • Roeselare, Belgium, 8800
        • Novartis Investigative Site
      • Ronse, Belgium, 9600
        • Novartis Investigative Site
      • Seraing, Belgium, 4100
        • Novartis Investigative Site
      • Sint-Gillis-Waas, Belgium, 9170
        • Novartis Investigative Site
      • Turnhout, Belgium, 2300
        • Novartis Investigative Site
      • Vilvoorde, Belgium, 1800
        • Novartis Investigative Site
      • Willebroek, Belgium, 2830
        • Novartis Investigative Site
  • Brazil
    • BA
      • Salvador, BA, Brazil, 40050-410
        • Novartis Investigative Site
    • CE
      • Fortaleza, CE, Brazil, 60430-370
        • Novartis Investigative Site
      • Fortaleza, CE, Brazil, 60120-021
        • Novartis Investigative Site
    • ES
      • Vitoria, ES, Brazil, 29040-091
        • Novartis Investigative Site
    • MG
      • Juiz de Fora, MG, Brazil, 36036-110
        • Novartis Investigative Site
    • PA
      • Belem, PA, Brazil, 66073-000
        • Novartis Investigative Site
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20551-030
        • Novartis Investigative Site
      • Rio de Janeiro, RJ, Brazil, 20020-020
        • Novartis Investigative Site
    • RS
      • Porto Alegre, RS, Brazil, 90020-090
        • Novartis Investigative Site
    • SP
      • Campinas, SP, Brazil, 13060-904
        • Novartis Investigative Site
      • Campinas, SP, Brazil, 13083-190
        • Novartis Investigative Site
      • Marilia, SP, Brazil, 17519-030
        • Novartis Investigative Site
      • Santos, SP, Brazil, 11045-904
        • Novartis Investigative Site
      • Sao Jose do Rio Preto, SP, Brazil, 15090-000
        • Novartis Investigative Site
      • Sorocaba, SP, Brazil, 18030-210
        • Novartis Investigative Site
      • São Paulo, SP, Brazil, 04023-900
        • Novartis Investigative Site
      • São Paulo, SP, Brazil, 05403-000
        • Novartis Investigative Site
  • Canada
      • Ouest-Montreal, Canada, H2W1R7
        • Novartis Investigative Site
    • Alberta
      • Edmonton, Alberta, Canada, T5J 3N4
        • Novartis Investigative Site
      • Edmonton, Alberta, Canada, T5N 3Y6
        • Novartis Investigative Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V6E 1M7
        • Novartis Investigative Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2V 4W3
        • Novartis Investigative Site
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • Novartis Investigative Site
    • Newfoundland and Labrador
      • Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
        • Novartis Investigative Site
      • St. John's, Newfoundland and Labrador, Canada, A1E 4J8
        • Novartis Investigative Site
    • Ontario
      • Brampton, Ontario, Canada, L6Z 4N5
        • Novartis Investigative Site
      • Burlington, Ontario, Canada, L7M 4Y1
        • Novartis Investigative Site
      • Cambridge, Ontario, Canada, N1R 6V6
        • Novartis Investigative Site
      • Courtice, Ontario, Canada, L1E 3C3
        • Novartis Investigative Site
      • Etobicoke, Ontario, Canada, M9R 4E1
        • Novartis Investigative Site
      • London, Ontario, Canada, N6A 4G5
        • Novartis Investigative Site
      • North Bay, Ontario, Canada, P1B 2H3
        • Novartis Investigative Site
      • Oakville, Ontario, Canada, L6H 3P1
        • Novartis Investigative Site
      • Oshawa, Ontario, Canada, L1J 2K1
        • Novartis Investigative Site
      • Ottawa, Ontario, Canada, K1H 7W9
        • Novartis Investigative Site
      • Scarborough, Ontario, Canada, M1H 3G4
        • Novartis Investigative Site
      • Thornhill, Ontario, Canada, L4J 8L7
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M4G 3E8
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M5C 2T2
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, N6G 4X8
        • Novartis Investigative Site
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Novartis Investigative Site
      • Mirabel, Quebec, Canada, J7J 2K8
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H1T 2M4
        • Novartis Investigative Site
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • Novartis Investigative Site
      • Québec, Quebec, Canada, G1G 3Y8
        • Novartis Investigative Site
      • Sainte-Foy, Quebec, Canada, G1W 4R4
        • Novartis Investigative Site
      • Sainte-Foy, Quebec, Canada, G1V 4G5
        • Novartis Investigative Site
      • Sherbrooke, Quebec, Canada, J1G 5K2
        • Novartis Investigative Site
      • Ste-Foy, Quebec, Canada, G1V 4G2
        • Novartis Investigative Site
      • Trois-Rivières, Quebec, Canada, G8Z 3R9
        • Novartis Investigative Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7H 5M3
        • Novartis Investigative Site
  • China
      • Beijing, China, 100029
        • Novartis Investigative Site
      • Beijing, China, 100034
        • Novartis Investigative Site
      • Beijing, China
        • Novartis Investigative Site
      • Beijing, China, 100028
        • Novartis Investigative Site
      • Beijing, China, 100176
        • Novartis Investigative Site
      • Beijing, China, 100088
        • Novartis Investigative Site
      • Chengdu, China, 610072
        • Novartis Investigative Site
      • Chongqing, China, 400038
        • Novartis Investigative Site
      • Dalian, China
        • Novartis Investigative Site
      • Guangzhou, China, 510000
        • Novartis Investigative Site
      • Shanghai, China, 200031
        • Novartis Investigative Site
      • Shanghai, China, 200003
        • Novartis Investigative Site
      • Shanghai, China, 200025
        • Novartis Investigative Site
      • Shanghai, China, 200233
        • Novartis Investigative Site
      • Tianjin, China, 300052
        • Novartis Investigative Site
      • Tianjin, China, 300142
        • Novartis Investigative Site
    • Beijing
      • Beijing, Beijing, China, 100730
        • Novartis Investigative Site
      • Beijing, Beijing, China, 100044
        • Novartis Investigative Site
      • Beijing, Beijing, China, 100083
        • Novartis Investigative Site
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • Novartis Investigative Site
      • Chongqing, Chongqing, China
        • Novartis Investigative Site
    • Fujian
      • Fuzhou, Fujian, China, 350025
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510180
        • Novartis Investigative Site
    • Hebei
      • Shijiazhuang, Hebei, China, 050051
        • Novartis Investigative Site
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • Novartis Investigative Site
      • Harbin, Heilongjiang, China, 150086
        • Novartis Investigative Site
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Novartis Investigative Site
    • Hunan
      • Changsha, Hunan, China, 410008
        • Novartis Investigative Site
      • Changsha City, Hunan, China, 410011
        • Novartis Investigative Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Novartis Investigative Site
      • Nanjing, Jiangsu, China, 210008
        • Novartis Investigative Site
      • Nanjing, Jiangsu, China, 210006
        • Novartis Investigative Site
      • Nanjing, Jiangsu, China, 210009
        • Novartis Investigative Site
      • Suzhou, Jiangsu, China, 215004
        • Novartis Investigative Site
    • Liaoning
      • Dalian, Liaoning, China, 116011
        • Novartis Investigative Site
      • Shenyang, Liaoning, China, 110003
        • Novartis Investigative Site
    • Shandong
      • Qingdao, Shandong, China, 266011
        • Novartis Investigative Site
    • Shanxi
      • Xi'an, Shanxi, China, 710032
        • Novartis Investigative Site
      • Xi'an, Shanxi, China, 710061
        • Novartis Investigative Site
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Novartis Investigative Site
    • Yunnan
      • Kunming, Yunnan, China, 650101
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Novartis Investigative Site
      • Hangzhou, Zhejiang, China, 310009
        • Novartis Investigative Site
      • Hangzhou, Zhejiang, China, 310003
        • Novartis Investigative Site
      • Hangzhou, Zhejiang, China, 310013
        • Novartis Investigative Site
  • Colombia
      • Bogotá, Colombia
        • Novartis Investigative Site
      • Cali, Colombia
        • Novartis Investigative Site
      • Florida Blanca, Colombia
        • Novartis Investigative Site
      • Medellín, Colombia
        • Novartis Investigative Site
  • Czech Republic
      • Brno, Czech Republic, 61300
        • Novartis Investigative Site
      • Brno-Bohunice, Czech Republic, 639 01
        • Novartis Investigative Site
      • Ceske Budejovice, Czech Republic, 370 87
        • Novartis Investigative Site
      • Ostrava, Czech Republic, 702 00
        • Novartis Investigative Site
      • Pardubice, Czech Republic, 53002
        • Novartis Investigative Site
      • Pisek, Czech Republic, 397 01
        • Novartis Investigative Site
      • Prague 2, Czech Republic, 128 02
        • Novartis Investigative Site
      • Prague 2, Czech Republic, 128 08
        • Novartis Investigative Site
      • Prague 4 - Krc, Czech Republic, 14059
        • Novartis Investigative Site
      • Prague 5 - Motol, Czech Republic, 15112
        • Novartis Investigative Site
  • Denmark
      • Aalborg, Denmark, DK-9100
        • Novartis Investigative Site
      • Copenhagen NV, Denmark, DK-2400
        • Novartis Investigative Site
      • Frederiksberg, Denmark, DK-2000
        • Novartis Investigative Site
      • Gentofte, Denmark, DK-2820
        • Novartis Investigative Site
      • Hillerød, Denmark, DK-3400
        • Novartis Investigative Site
      • Hvidovre, Denmark, 2650
        • Novartis Investigative Site
      • Roskilde, Denmark, DK-4000
        • Novartis Investigative Site
      • Slagelse, Denmark, DK-4200
        • Novartis Investigative Site
      • Svendborg, Denmark, DK-5700
        • Novartis Investigative Site
      • Århus, Denmark, DK-8000
        • Novartis Investigative Site
  • Finland
      • Helsinki, Finland, 00250
        • Novartis Investigative Site
      • Hyvinkää, Finland, FIN-05850
        • Novartis Investigative Site
      • Kajaani, Finland, FIN-87140
        • Novartis Investigative Site
      • Kuopio, Finland, FIN-70211
        • Novartis Investigative Site
      • Lohja, Finland, FIN-08200
        • Novartis Investigative Site
      • OYS, Finland, FIN-90029
        • Novartis Investigative Site
      • Oulu, Finland, 90100
        • Novartis Investigative Site
      • Pori, Finland, 28120
        • Novartis Investigative Site
      • Tammisaari, Finland, 10600
        • Novartis Investigative Site
      • Tampere, Finland, 33520
        • Novartis Investigative Site
      • Valkeakoski, Finland, 37600
        • Novartis Investigative Site
  • France
      • Besancon Cedex, France, 25030
        • Novartis Investigative Site
      • Bondy, France, 93143
        • Novartis Investigative Site
      • Corbeil Essonnes, France, 91100
        • Novartis Investigative Site
      • Grenoble, France, 38043
        • Novartis Investigative Site
      • La Rochelle, France, 17019
        • Novartis Investigative Site
      • Lagny sur Marne, France, 77405
        • Novartis Investigative Site
      • Limoges Cedex, France, 87042
        • Novartis Investigative Site
      • Lyon, France, 69437
        • Novartis Investigative Site
      • Lyon Cedex 03, France, 69394
        • Novartis Investigative Site
      • Paris Cedex 4, France, 75181
        • Novartis Investigative Site
      • Paris cedex 18, France, 75877
        • Novartis Investigative Site
      • Poitiers Cedex, France, 86021
        • Novartis Investigative Site
  • Germany
      • Aschaffenburg, Germany, 63739
        • Novartis Investigative Site
      • Aschaffenburg, Germany, 63741
        • Novartis Investigative Site
      • Asslar, Germany, 35614
        • Novartis Investigative Site
      • Bad Oeynhausen, Germany, 32545
        • Novartis Investigative Site
      • Barsinghausen, Germany, 30890
        • Novartis Investigative Site
      • Bensheim, Germany, 64625
        • Novartis Investigative Site
      • Berlin, Germany, 13055
        • Novartis Investigative Site
      • Berlin, Germany, 13597
        • Novartis Investigative Site
      • Berlin, Germany, 14193
        • Novartis Investigative Site
      • Bonn, Germany, 53105
        • Novartis Investigative Site
      • Bottrop, Germany, 46242
        • Novartis Investigative Site
      • Bremen, Germany, 28277
        • Novartis Investigative Site
      • Bretten, Germany, 75015
        • Novartis Investigative Site
      • Cloppenburg, Germany, 49661
        • Novartis Investigative Site
      • Dippoldiswalde, Germany, 01744
        • Novartis Investigative Site
      • Dresden, Germany, 01307
        • Novartis Investigative Site
      • Dresden, Germany, 01127
        • Novartis Investigative Site
      • Duesseldorf, Germany, 40210
        • Novartis Investigative Site
      • Essen, Germany, 45138
        • Novartis Investigative Site
      • Essen, Germany, 45127
        • Novartis Investigative Site
      • Essen, Germany, 45134
        • Novartis Investigative Site
      • Fuldatal, Germany, 34233
        • Novartis Investigative Site
      • Göttingen, Germany, 37075
        • Novartis Investigative Site
      • Hagen, Germany, 58095
        • Novartis Investigative Site
      • Hamburg, Germany, 22335
        • Novartis Investigative Site
      • Hamburg, Germany, 22393
        • Novartis Investigative Site
      • Hannover, Germany, 30625
        • Novartis Investigative Site
      • Heidelberg, Germany, 69120
        • Novartis Investigative Site
      • Heilbronn, Germany, 74076
        • Novartis Investigative Site
      • Heilbronn, Germany, 74072
        • Novartis Investigative Site
      • Ingelheim, Germany, 55218
        • Novartis Investigative Site
      • Jena, Germany, 07743
        • Novartis Investigative Site
      • Kassel, Germany, 34117
        • Novartis Investigative Site
      • Krefeld, Germany, 47798
        • Novartis Investigative Site
      • Magdeburg, Germany, 39120
        • Novartis Investigative Site
      • Mainz, Germany, 55131
        • Novartis Investigative Site
      • Messkirch, Germany, 88605
        • Novartis Investigative Site
      • Muehldorf am Inn, Germany, 84453
        • Novartis Investigative Site
      • Neuwied, Germany, 56564
        • Novartis Investigative Site
      • Offenbach, Germany, 63065
        • Novartis Investigative Site
      • Rehburg-Loccum, Germany, 31547
        • Novartis Investigative Site
      • Riesa, Germany, 01587
        • Novartis Investigative Site
      • Schauenburg-Elgershausen, Germany, 34270
        • Novartis Investigative Site
      • Schwabenheim, Germany, 55270
        • Novartis Investigative Site
      • St. Ingbert - Oberwuerzbach, Germany, 66386
        • Novartis Investigative Site
      • Ursensollen, Germany, 92289
        • Novartis Investigative Site
      • Wetter, Germany, 58300
        • Novartis Investigative Site
      • Wiehl, Germany, 51674
        • Novartis Investigative Site
      • Wiesbaden, Germany, 65183
        • Novartis Investigative Site
      • Wuerzburg, Germany, 97072
        • Novartis Investigative Site
  • Greece
      • Alexandroupolis, Greece, GR 68 100
        • Novartis Investigative Site
      • Athens, Greece
        • Novartis Investigative Site
      • Athens, Greece, GR 11527
        • Novartis Investigative Site
      • Athens, Greece, GR 115 27
        • Novartis Investigative Site
      • Athens, Greece, GR 115 22
        • Novartis Investigative Site
      • Athens, Greece, GR 115 21
        • Novartis Investigative Site
      • Athens - GR, Greece, 10676
        • Novartis Investigative Site
      • Ioannina, Greece, GR 45500
        • Novartis Investigative Site
      • Patras, Greece, 26500
        • Novartis Investigative Site
      • Piraeurs, Greece, GR 184 54
        • Novartis Investigative Site
      • Thessaloniki, Greece, 57001
        • Novartis Investigative Site
      • Thessaloniki, Greece, GR 546 39
        • Novartis Investigative Site
  • Guatemala
      • Guatemala City, Guatemala, 01010
        • Novartis Investigative Site
      • Guatemala City, Guatemala, 01001
        • Novartis Investigative Site
      • Guatemala City, Guatemala, 01011
        • Novartis Investigative Site
      • Guatemala City, Guatemala, 01015
        • Novartis Investigative Site
  • Hungary
      • Baja, Hungary, 6500
        • Novartis Investigative Site
      • Balatonfured, Hungary, 8230
        • Novartis Investigative Site
      • Budapest, Hungary, 1083
        • Novartis Investigative Site
      • Budapest, Hungary, 1085
        • Novartis Investigative Site
      • Budapest, Hungary, 1062
        • Novartis Investigative Site
      • Budapest, Hungary, H-1032
        • Novartis Investigative Site
      • Budapest, Hungary, 1096
        • Novartis Investigative Site
      • Budapest, Hungary, 1115
        • Novartis Investigative Site
      • Debrecen, Hungary, 4032
        • Novartis Investigative Site
      • Debrecen, Hungary, 4004
        • Novartis Investigative Site
      • Gyula, Hungary, 5703
        • Novartis Investigative Site
      • Kaposvar, Hungary, 7400
        • Novartis Investigative Site
      • Miskolc, Hungary, 3526
        • Novartis Investigative Site
      • Pecs, Hungary, 7324
        • Novartis Investigative Site
      • Szeged, Hungary, 6720
        • Novartis Investigative Site
      • Zalaegerszeg, Hungary, 8900
        • Novartis Investigative Site
  • India
      • Bangalore, India, 560 034
        • Novartis Investigative Site
      • Chennai, India, 600086
        • Novartis Investigative Site
      • Chennai, India, 600010
        • Novartis Investigative Site
      • Hyderabad, India, 500 063
        • Novartis Investigative Site
      • Kolkota, India, 700020
        • Novartis Investigative Site
      • New Delhi, India, 110 029
        • Novartis Investigative Site
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500018
        • Novartis Investigative Site
      • Hyderabad, Andhra Pradesh, India, 500012
        • Novartis Investigative Site
      • Hyderabad, Andhra Pradesh, India, 500001
        • Novartis Investigative Site
    • Andhra Pradesh, INDIA
      • Hyderabad, Andhra Pradesh, INDIA, India, 500034
        • Novartis Investigative Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380014
        • Novartis Investigative Site
    • Karnataka
      • Bangalore, Karnataka, India, 560054
        • Novartis Investigative Site
      • Banglaore, Karnataka, India, 560038
        • Novartis Investigative Site
      • Mangalore, Karnataka, India, 575001
        • Novartis Investigative Site
    • Kerala
      • Kochi, Kerala, India, 682 026
        • Novartis Investigative Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400008
        • Novartis Investigative Site
      • Pune, Maharashtra, India, 411011
        • Novartis Investigative Site
      • Pune, Maharashtra, India, 411030
        • Novartis Investigative Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600013
        • Novartis Investigative Site
      • Vellore, Tamil Nadu, India, 632004
        • Novartis Investigative Site
  • Italy
      • Isernia, Italy, 86170
        • Novartis Investigative Site
      • Napoli, Italy, 80131
        • Novartis Investigative Site
    • AQ
      • L'Aquila, AQ, Italy, 67100
        • Novartis Investigative Site
    • BG
      • Bergamo, BG, Italy, 24128
        • Novartis Investigative Site
    • BL
      • Belluno, BL, Italy, 32100
        • Novartis Investigative Site
    • BO
      • Bologna, BO, Italy, 40138
        • Novartis Investigative Site
    • CB
      • Campobasso, CB, Italy, 86100
        • Novartis Investigative Site
    • CE
      • Caserta, CE, Italy, 81100
        • Novartis Investigative Site
    • CH
      • Chieti, CH, Italy, 66100
        • Novartis Investigative Site
    • CN
      • Cuneo, CN, Italy, 12100
        • Novartis Investigative Site
    • CS
      • Cosenza, CS, Italy, 87100
        • Novartis Investigative Site
    • CZ
      • Catanzaro, CZ, Italy, 88100
        • Novartis Investigative Site
    • FE
      • Cona, FE, Italy, 44100
        • Novartis Investigative Site
    • FG
      • Foggia, FG, Italy, 71100
        • Novartis Investigative Site
    • FI
      • Firenze, FI, Italy, 50134
        • Novartis Investigative Site
    • GE
      • Arenzano, GE, Italy, 16011
        • Novartis Investigative Site
      • Genova, GE, Italy, 16132
        • Novartis Investigative Site
    • IS
      • Pozzilli, IS, Italy, 86077
        • Novartis Investigative Site
    • LC
      • Lecco, LC, Italy, 23900
        • Novartis Investigative Site
    • MB
      • Monza, MB, Italy, 20900
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italy, 20132
        • Novartis Investigative Site
      • Milano, MI, Italy, 20123
        • Novartis Investigative Site
      • Milano, MI, Italy, 20157
        • Novartis Investigative Site
      • Milano, MI, Italy, 20146
        • Novartis Investigative Site
      • Passirana di Rho, MI, Italy, 20017
        • Novartis Investigative Site
    • PA
      • Palermo, PA, Italy, 90127
        • Novartis Investigative Site
    • PG
      • Perugia, PG, Italy, 06100
        • Novartis Investigative Site
    • PI
      • Pisa, PI, Italy, 56124
        • Novartis Investigative Site
      • Pisa, PI, Italy, 56126
        • Novartis Investigative Site
    • PN
      • Pordenone, PN, Italy, 33170
        • Novartis Investigative Site
    • PR
      • Parma, PR, Italy, 43100
        • Novartis Investigative Site
    • PV
      • Casorate Primo, PV, Italy, 27022
        • Novartis Investigative Site
      • Pavia, PV, Italy, 27100
        • Novartis Investigative Site
      • Stradella, PV, Italy, 27049
        • Novartis Investigative Site
    • RA
      • Ravenna, RA, Italy, 48100
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italy, 00161
        • Novartis Investigative Site
      • Roma, RM, Italy, 00133
        • Novartis Investigative Site
      • Roma, RM, Italy, 00189
        • Novartis Investigative Site
      • Roma, RM, Italy, 00163
        • Novartis Investigative Site
      • Roma, RM, Italy, 00122
        • Novartis Investigative Site
      • Roma, RM, Italy, 00157
        • Novartis Investigative Site
      • Roma, RM, Italy, 00186
        • Novartis Investigative Site
    • SA
      • Cava De' Tirreni, SA, Italy, 84013
        • Novartis Investigative Site
      • Mercato San Severino, SA, Italy, 84085
        • Novartis Investigative Site
      • Salerno, SA, Italy, 84125
        • Novartis Investigative Site
    • SI
      • Siena, SI, Italy, 53100
        • Novartis Investigative Site
    • SS
      • Olbia, SS, Italy, 07026
        • Novartis Investigative Site
      • Sassari, SS, Italy, 07100
        • Novartis Investigative Site
    • TO
      • Torino, TO, Italy, 10126
        • Novartis Investigative Site
      • Torino, TO, Italy, 10128
        • Novartis Investigative Site
      • Torino, TO, Italy, 10154
        • Novartis Investigative Site
    • TV
      • Vittorio Veneto, TV, Italy, 31029
        • Novartis Investigative Site
    • UD
      • San Daniele Del Friuli, UD, Italy, 33038
        • Novartis Investigative Site
      • Udine, UD, Italy, 33100
        • Novartis Investigative Site
    • VE
      • Venezia, VE, Italy, 30174
        • Novartis Investigative Site
    • VR
      • Verona, VR, Italy, 37126
        • Novartis Investigative Site
  • Japan
      • Oita, Japan, 870-0039
        • Novartis Investigative Site
      • Oita, Japan, 870-0192
        • Novartis Investigative Site
      • Okayama, Japan, 701-1192
        • Novartis Investigative Site
    • Aichi
      • Nagoya, Aichi, Japan, 460-0001
        • Novartis Investigative Site
      • Nagoya, Aichi, Japan, 455-8530
        • Novartis Investigative Site
      • Nagoya, Aichi, Japan, 451-8511
        • Novartis Investigative Site
      • Nagoya, Aichi, Japan, 462-0802
        • Novartis Investigative Site
      • Nagoya, Aichi, Japan, 462-0825
        • Novartis Investigative Site
    • Chiba
      • Asahi, Chiba, Japan, 289-2511
        • Novartis Investigative Site
    • Fukuoka
      • Kasuga, Fukuoka, Japan, 816-0864
        • Novartis Investigative Site
      • Kitakyushu, Fukuoka, Japan, 800-0296
        • Novartis Investigative Site
    • Fukushima
      • Koriyama-city, Fukushima, Japan, 963-8851
        • Novartis Investigative Site
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 078-8211
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japan, 003-0023
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japan, 060-0033
        • Novartis Investigative Site
      • Sapporo-city, Hokkaido, Japan, 060-8648
        • Novartis Investigative Site
    • Ibaraki
      • Toride-city, Ibaraki, Japan, 302-0022
        • Novartis Investigative Site
    • Kagawa
      • Takamatsu, Kagawa, Japan, 7600076
        • Novartis Investigative Site
    • Kagoshima
      • Aira-city, Kagoshima, Japan, 899-5431
        • Novartis Investigative Site
    • Kanagawa
      • Isehara-city, Kanagawa, Japan, 259-1131
        • Novartis Investigative Site
      • Kawasaki, Kanagawa, Japan, 210-0852
        • Novartis Investigative Site
    • Kumamoto
      • Yatsushiro, Kumamoto, Japan, 866-8660
        • Novartis Investigative Site
    • Kyoto
      • Kyoto-city, Kyoto, Japan, 612-8555
        • Novartis Investigative Site
      • Kyoto-city, Kyoto, Japan, 615-0035
        • Novartis Investigative Site
    • Miyagi
      • Sendai-city, Miyagi, Japan, 980-8574
        • Novartis Investigative Site
    • Nagano
      • Suwa, Nagano, Japan, 392-8510
        • Novartis Investigative Site
    • Okayama
      • Okayama-city, Okayama, Japan, 700-8558
        • Novartis Investigative Site
    • Osaka
      • Takatsuki-city, Osaka, Japan, 569-1096
        • Novartis Investigative Site
      • Toyonaka, Osaka, Japan, 561-0871
        • Novartis Investigative Site
      • Yao-city, Osaka, Japan, 581-0011
        • Novartis Investigative Site
    • Saitama
      • Tokorozawa, Saitama, Japan, 351-1151
        • Novartis Investigative Site
    • Shiga
      • Ohtsu-city, Shiga, Japan, 520-2192
        • Novartis Investigative Site
    • Shizuoka
      • Shimizu, Shizuoka, Japan, 411-8611
        • Novartis Investigative Site
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8655
        • Novartis Investigative Site
      • Chuo-ku, Tokyo, Japan, 103-0002
        • Novartis Investigative Site
    • Toyama
      • Takaoka, Toyama, Japan, 933-0955
        • Novartis Investigative Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 602-739
        • Novartis Investigative Site
      • Daejeon, Korea, Republic of, 301-747
        • Novartis Investigative Site
      • Incheon, Korea, Republic of, 400-712
        • Novartis Investigative Site
      • Pusan, Korea, Republic of, 614-735
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 137-701
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 152-703
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 156-707
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 135-720
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 136 705
        • Novartis Investigative Site
      • Taegu, Korea, Republic of, 700 - 721
        • Novartis Investigative Site
    • Gyeonggi-do
      • Ansan, Gyeonggi-do, Korea, Republic of, 425-801
        • Novartis Investigative Site
      • Anyang, Gyeonggi-do, Korea, Republic of, 431-070
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, Korea, Republic of, 120-752
        • Novartis Investigative Site
      • Seoul, Korea, Korea, Republic of, 110 744
        • Novartis Investigative Site
      • Seoul, Korea, Korea, Republic of, 135-710
        • Novartis Investigative Site
    • Seongnam
      • Bundang, Seongnam, Korea, Republic of, 463-707
        • Novartis Investigative Site
  • Lithuania
      • Kaunas, Lithuania, 50009
        • Novartis Investigative Site
      • Klaipeda, Lithuania, 92304
        • Novartis Investigative Site
      • Vilnius, Lithuania, LT-08661
        • Novartis Investigative Site
      • Vilnius, Lithuania
        • Novartis Investigative Site
  • Netherlands
      • Alkmaar, Netherlands, 1851 JD
        • Novartis Investigative Site
      • Almelo, Netherlands, 7609 PP
        • Novartis Investigative Site
      • Amersfoort, Netherlands, 3800 BM
        • Novartis Investigative Site
      • Amsterdam, Netherlands, 1061 AE
        • Novartis Investigative Site
      • Apeldoorn, Netherlands, 7334 DZ
        • Novartis Investigative Site
      • Arnhem, Netherlands, 6815 AD
        • Novartis Investigative Site
      • Breda, Netherlands, 4818 CK
        • Novartis Investigative Site
      • Delft, Netherlands, 2625 AD
        • Novartis Investigative Site
      • Den Helder, Netherlands, 1782 GZ
        • Novartis Investigative Site
      • Deventer, Netherlands, 7416 SE
        • Novartis Investigative Site
      • Doetinchem, Netherlands, 7009 BL
        • Novartis Investigative Site
      • Dordrecht, Netherlands, 3318AT
        • Novartis Investigative Site
      • Eindhoven, Netherlands, 5623 EJ
        • Novartis Investigative Site
      • Eindhoven, Netherlands, 5631 BM
        • Novartis Investigative Site
      • Goes, Netherlands, 4462 RA
        • Novartis Investigative Site
      • Groningen, Netherlands, 9713 GZ
        • Novartis Investigative Site
      • Heerlen, Netherlands, 6419 PC
        • Novartis Investigative Site
      • Hoogeveen, Netherlands, 7909 AA
        • Novartis Investigative Site
      • Hoogwoud, Netherlands, 1718 BG
        • Novartis Investigative Site
      • Losser, Netherlands, 7581 BV
        • Novartis Investigative Site
      • Meppel, Netherlands, 7943 KA
        • Novartis Investigative Site
      • Nieuwegein, Netherlands, 3435 CM
        • Novartis Investigative Site
      • Oude Pekela, Netherlands, 9665 AR
        • Novartis Investigative Site
      • Rotterdam, Netherlands, 3083 AN
        • Novartis Investigative Site
      • Rotterdam, Netherlands, 3015 CE
        • Novartis Investigative Site
      • Rotterdam, Netherlands, 3045 PM
        • Novartis Investigative Site
      • Tiel, Netherlands, 4002 WP
        • Novartis Investigative Site
      • Utrecht, Netherlands, 3508 GA
        • Novartis Investigative Site
      • Venlo, Netherlands, 5912 BL
        • Novartis Investigative Site
      • Woerden, Netherlands, 3443 GG
        • Novartis Investigative Site
      • Zwijndrecht, Netherlands, NL-3331 LZ
        • Novartis Investigative Site
      • Zwolle, Netherlands, 8025 AB
        • Novartis Investigative Site
  • Norway
      • Bergen, Norway, 5013
        • Novartis Investigative Site
      • Fredrikstad, Norway, 1607
        • Novartis Investigative Site
      • Horten, Norway, 3191
        • Novartis Investigative Site
      • Hønefoss, Norway, 3515
        • Novartis Investigative Site
      • Oslo, Norway, 0160
        • Novartis Investigative Site
      • Skedsmokorset, Norway, 2020
        • Novartis Investigative Site
      • Skien, Norway, 3722
        • Novartis Investigative Site
      • Spikkestad, Norway, 3430
        • Novartis Investigative Site
      • Stavanger, Norway, 4011
        • Novartis Investigative Site
      • Svelvik, Norway, 3060
        • Novartis Investigative Site
      • Tromsø, Norway, NO-9038
        • Novartis Investigative Site
      • Trondheim, Norway, NO-7011
        • Novartis Investigative Site
      • Tønsberg, Norway, 3103
        • Novartis Investigative Site
  • Peru
    • Lima
      • Bellavista, Lima, Peru, CALLAO 02
        • Novartis Investigative Site
      • Cercado de Lima, Lima, Peru, 01
        • Novartis Investigative Site
      • San Borja, Lima, Peru, 41
        • Novartis Investigative Site
      • San Isidro, Lima, Peru, 27
        • Novartis Investigative Site
      • San Martin de Porres, Lima, Peru, 31
        • Novartis Investigative Site
      • Santiago de Surco, Lima, Peru, 33
        • Novartis Investigative Site
  • Portugal
      • Almada, Portugal, 2801-951
        • Novartis Investigative Site
      • Amadora, Portugal, 2720-276
        • Novartis Investigative Site
      • Coimbra, Portugal, 3000-075
        • Novartis Investigative Site
      • Linda-a-Velha, Portugal, 2799-523
        • Novartis Investigative Site
      • Lisboa, Portugal, 1649-035
        • Novartis Investigative Site
      • Lisboa, Portugal, 1169-024
        • Novartis Investigative Site
      • Lisboa, Portugal, 1495-005
        • Novartis Investigative Site
      • Lisboa, Portugal, 1250-203
        • Novartis Investigative Site
      • Matosinhos, Portugal, 4454-509
        • Novartis Investigative Site
      • Portimão, Portugal, 8500-388
        • Novartis Investigative Site
      • Porto, Portugal, 4200-319
        • Novartis Investigative Site
      • Santa Maria da Feira, Portugal, 4520-211
        • Novartis Investigative Site
      • Santarém, Portugal, 2000-153
        • Novartis Investigative Site
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Novartis Investigative Site
      • Ponce, Puerto Rico, 00733-1471
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 119074
        • Novartis Investigative Site
      • Singapore, Singapore, 169608
        • Novartis Investigative Site
      • Singapore, Singapore, 308433
        • Novartis Investigative Site
      • Singapore, Singapore, 168752
        • Novartis Investigative Site
      • Singapore, Singapore, 159964
        • Novartis Investigative Site
  • Slovakia
      • Banksa Bystrica, Slovakia, SK 97 517
        • Novartis Investigative Site
      • Bratislava, Slovakia, 833 48
        • Novartis Investigative Site
      • Bratislava, Slovakia, 851 07
        • Novartis Investigative Site
      • Bratislava, Slovakia, 81369
        • Novartis Investigative Site
      • Bratislava, Slovakia, 811 08
        • Novartis Investigative Site
      • Bratislava, Slovakia, 812 72
        • Novartis Investigative Site
      • Kosice, Slovakia, 040 01
        • Novartis Investigative Site
      • Lubochna, Slovakia, SK 03491
        • Novartis Investigative Site
      • Lucenec, Slovakia, 98439
        • Novartis Investigative Site
      • Martin, Slovakia, 03601
        • Novartis Investigative Site
      • Nitra, Slovakia, 949 01
        • Novartis Investigative Site
      • Piestany, Slovakia, 921 01
        • Novartis Investigative Site
      • Prievidza, Slovakia, 971 01
        • Novartis Investigative Site
      • Trstena, Slovakia, 549 16
        • Novartis Investigative Site
    • Slovak Republic
      • Bratislava, Slovak Republic, Slovakia, 826 06
        • Novartis Investigative Site
      • Kosice, Slovak Republic, Slovakia, 040 22
        • Novartis Investigative Site
      • Zilina, Slovak Republic, Slovakia, 010 01
        • Novartis Investigative Site
  • South Africa
      • Cape Town, South Africa, 7925
        • Novartis Investigative Site
      • Durban, South Africa, 4001
        • Novartis Investigative Site
      • Durban, South Africa, 4110
        • Novartis Investigative Site
      • Durban, South Africa, 4030
        • Novartis Investigative Site
      • Durban, South Africa, 4052
        • Novartis Investigative Site
      • Gauteng, South Africa
        • Novartis Investigative Site
      • Johannesburg, South Africa, 2196
        • Novartis Investigative Site
      • Port Elizabeth, South Africa, 6001
        • Novartis Investigative Site
      • Pretoria, South Africa, 0002
        • Novartis Investigative Site
    • Western Cape
      • Somerset West, Western Cape, South Africa, 7130
        • Novartis Investigative Site
  • Spain
      • Hospitalet de Llbregat, Spain, 08902
        • Novartis Investigative Site
      • Hospitalet de Llobregat, Spain
        • Novartis Investigative Site
      • Madrid, Spain, 28041
        • Novartis Investigative Site
      • Madrid, Spain, 28034
        • Novartis Investigative Site
      • Madrid, Spain, 28046
        • Novartis Investigative Site
      • Madrid, Spain, 28040
        • Novartis Investigative Site
      • Madrid, Spain, 28035
        • Novartis Investigative Site
      • Madrid, Spain, 28770
        • Novartis Investigative Site
    • Andalucia
      • Cadiz, Andalucia, Spain, 11010
        • Novartis Investigative Site
      • Granada, Andalucia, Spain, 18014
        • Novartis Investigative Site
      • Jerez de La Frontera, Andalucia, Spain, 11407
        • Novartis Investigative Site
      • Malaga, Andalucia, Spain, 29010
        • Novartis Investigative Site
      • Malaga, Andalucia, Spain, 29018
        • Novartis Investigative Site
      • Málaga, Andalucia, Spain, 29010
        • Novartis Investigative Site
      • Puerto de Santa Maria, Andalucia, Spain, 11500
        • Novartis Investigative Site
      • Sanlúcar de Barrameda, Andalucia, Spain, 11540
        • Novartis Investigative Site
      • Sevilla, Andalucia, Spain, 41009
        • Novartis Investigative Site
    • Asturias
      • Oviedo, Asturias, Spain, 33006
        • Novartis Investigative Site
      • Oviedo, Asturias, Spain, 33008
        • Novartis Investigative Site
      • Oviedo, Asturias, Spain, 33010
        • Novartis Investigative Site
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Novartis Investigative Site
      • Sabadell, Barcelona, Spain, 08208
        • Novartis Investigative Site
    • Castilla la Mancha
      • Alcazar de San Juan, Castilla la Mancha, Spain, 13600
        • Novartis Investigative Site
    • Castilla y Leon
      • Aranda de Duero, Castilla y Leon, Spain, 09400
        • Novartis Investigative Site
      • Miranda de Ebro, Castilla y Leon, Spain, 09200
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spain, 08025
        • Novartis Investigative Site
    • Cataluña
      • Barcelona, Cataluña, Spain, 08025
        • Novartis Investigative Site
      • Barcelona, Cataluña, Spain, 08905
        • Novartis Investigative Site
      • Girona, Cataluña, Spain, 17007
        • Novartis Investigative Site
      • La Pobla Llarga, Cataluña, Spain, 46670
        • Novartis Investigative Site
      • Llança, Cataluña, Spain, 17490
        • Novartis Investigative Site
      • Manresa, Cataluña, Spain, 08240
        • Novartis Investigative Site
      • Mollet del Vallés, Cataluña, Spain, 08100
        • Novartis Investigative Site
      • Rubi, Cataluña, Spain, 08191
        • Novartis Investigative Site
      • Santa Coloma de Gramanet, Cataluña, Spain, 08923
        • Novartis Investigative Site
      • Tarrega, Cataluña, Spain, 25300
        • Novartis Investigative Site
      • Vic, Cataluña, Spain, 08500
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Alacuas, Comunidad Valenciana, Spain, 46970
        • Novartis Investigative Site
      • Alicante, Comunidad Valenciana, Spain, 03004
        • Novartis Investigative Site
      • Alzira, Comunidad Valenciana, Spain, 46600
        • Novartis Investigative Site
      • Benidorm, Comunidad Valenciana, Spain, 03550
        • Novartis Investigative Site
      • Puerto de Sagunto, Comunidad Valenciana, Spain, 46520
        • Novartis Investigative Site
      • Quart de Poblet, Comunidad Valenciana, Spain, 46930
        • Novartis Investigative Site
      • Valencia, Comunidad Valenciana, Spain, 46014
        • Novartis Investigative Site
      • Valencia, Comunidad Valenciana, Spain, 46010
        • Novartis Investigative Site
      • Valencia, Comunidad Valenciana, Spain, 46017
        • Novartis Investigative Site
      • Valencia, Comunidad Valenciana, Spain, 46019
        • Novartis Investigative Site
      • Valencia, Comunidad Valenciana, Spain, 46011
        • Novartis Investigative Site
      • Xixona, Comunidad Valenciana, Spain, 03100
        • Novartis Investigative Site
    • Extremadura
      • Mérida, Extremadura, Spain, 06800
        • Novartis Investigative Site
    • Galicia
      • Begonte, Galicia, Spain, 27373
        • Novartis Investigative Site
      • Ferrol, Galicia, Spain, 15405
        • Novartis Investigative Site
      • La Coruña, Galicia, Spain, 15010
        • Novartis Investigative Site
      • Pontevedra, Galicia, Spain, 36071
        • Novartis Investigative Site
      • Santiago de Compostela, Galicia, Spain, 15706
        • Novartis Investigative Site
      • Vigo, Galicia, Spain, 36200
        • Novartis Investigative Site
    • Islas Baleares
      • Palma De Mallorca, Islas Baleares, Spain
        • Novartis Investigative Site
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Novartis Investigative Site
      • Arganda del Rey, Madrid, Spain, 28500
        • Novartis Investigative Site
      • Civdad Real, Madrid, Spain, 13002
        • Novartis Investigative Site
      • Murcia, Madrid, Spain, 30007
        • Novartis Investigative Site
    • Pais Vasco
      • Plentzia, Pais Vasco, Spain, 48620
        • Novartis Investigative Site
      • San Sebastian, Pais Vasco, Spain, 20014
        • Novartis Investigative Site
      • Villabona, Pais Vasco, Spain, 20150
        • Novartis Investigative Site
      • Zumarraga, Pais Vasco, Spain, 20700
        • Novartis Investigative Site
    • Rioja
      • Alfaro, Rioja, Spain, 26540
        • Novartis Investigative Site
      • Logroño, Rioja, Spain, 26005
        • Novartis Investigative Site
  • Sweden
      • Göteborg, Sweden, SE-412 55
        • Novartis Investigative Site
      • Helsingborg, Sweden, 251 87
        • Novartis Investigative Site
      • Karlstad, Sweden, 651 85
        • Novartis Investigative Site
      • Malmö, Sweden, 21152
        • Novartis Investigative Site
      • Rättvik, Sweden, 79530
        • Novartis Investigative Site
      • Stenstorp, Sweden, SE-521 60
        • Novartis Investigative Site
      • Uppsala, Sweden, 751 85
        • Novartis Investigative Site
      • Varberg, Sweden, s-432 81
        • Novartis Investigative Site
  • Switzerland
      • Ascona, Switzerland
        • Novartis Investigative Site
      • Bern, Switzerland, 3010
        • Novartis Investigative Site
      • Bolligen, Switzerland, 3065
        • Novartis Investigative Site
      • Bruderholz, Switzerland, 4101
        • Novartis Investigative Site
      • Fribourg, Switzerland, 1700
        • Novartis Investigative Site
      • La Chaux-de-Fonds, Switzerland, 2300
        • Novartis Investigative Site
      • Lausanne, Switzerland, 1011
        • Novartis Investigative Site
      • Lugano, Switzerland, 6903
        • Novartis Investigative Site
      • Lugano, Switzerland, 6900
        • Novartis Investigative Site
      • Renens, Switzerland, 1020
        • Novartis Investigative Site
      • Schaffhausen, Switzerland, 8200
        • Novartis Investigative Site
      • St. Gallen, Switzerland, 9007
        • Novartis Investigative Site
      • Winterthur, Switzerland, 8400
        • Novartis Investigative Site
      • Zuerich, Switzerland, 8091
        • Novartis Investigative Site
    • CH
      • Estavayer-le-Lac, CH, Switzerland, 1470
        • Novartis Investigative Site
  • Taiwan
      • Changhua, Taiwan, 500
        • Novartis Investigative Site
      • Kaohsiung, Taiwan, 807
        • Novartis Investigative Site
      • Niaosong Township, Taiwan, 83301
        • Novartis Investigative Site
      • Taichung, Taiwan, 40705
        • Novartis Investigative Site
      • Taichung, Taiwan
        • Novartis Investigative Site
      • Taichung County, Taiwan
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Novartis Investigative Site
      • Taipei, Taiwan
        • Novartis Investigative Site
      • Taipei, Taiwan, 114
        • Novartis Investigative Site
    • Tainan
      • Yungkang, Tainan, Taiwan, 710
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand, 10330
        • Novartis Investigative Site
      • Bangkok, Thailand, 10700
        • Novartis Investigative Site
      • Bangkok, Thailand, 10400
        • Novartis Investigative Site
      • Chiang Mai, Thailand, 50200
        • Novartis Investigative Site
  • Turkey
      • Altunizade, Turkey, 34662
        • Novartis Investigative Site
      • Ankara, Turkey, 06100
        • Novartis Investigative Site
      • Ankara, Turkey, 06590
        • Novartis Investigative Site
      • Gaziantep, Turkey, 27070
        • Novartis Investigative Site
      • Izmir, Turkey, 35040
        • Novartis Investigative Site
      • Izmir, Turkey, 35340
        • Novartis Investigative Site
      • Kocaeli, Turkey, 41380
        • Novartis Investigative Site
  • United Kingdom
      • Bath, United Kingdom, BA2 3HT
        • Novartis Investigative Site
      • Cardiff, United Kingdom, CF5 4AD
        • Novartis Investigative Site
      • Cardiff, United Kingdom, CF14 4XN
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      • Glasgow, United Kingdom, G21 3UW
        • Novartis Investigative Site
      • Glasgow, United Kingdom, G11 6NT
        • Novartis Investigative Site
      • Irvine, United Kingdom, KA12 0AY
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      • Lancashire, United Kingdom, FY3 7EN
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      • Lancashire, United Kingdom, FY4 3AD
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      • London, United Kingdom, SE1 9RT
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      • London, United Kingdom, SW17 0QT
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      • London, United Kingdom, NW10 7NS
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      • Manchester, United Kingdom, M13 9NT
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      • Merseyside, United Kingdom, L7 8PX
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      • Rugby, United Kingdom, CV21 5 PX
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      • Vale of Glanmorgan, United Kingdom, CF63 4AR
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      • Wrexham, United Kingdom, LL13 7TD
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    • Buckinghamshire
      • High Wycombe, Buckinghamshire, United Kingdom, HP11 2TT
        • Novartis Investigative Site
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LJ
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    • Devon
      • Paignton, Devon, United Kingdom, TQ4 5LA
        • Novartis Investigative Site
    • England
      • Cornwall, England, United Kingdom, PL23 1DT
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    • Hertfordshire
      • Welwyn Garden City,, Hertfordshire, United Kingdom, AL7 4HQ
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    • Kent
      • Gravesend, Kent, United Kingdom, DA1 24JW
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    • Scotland
      • Glasgow, Scotland, United Kingdom, G12 8TA
        • Novartis Investigative Site
    • Surrey
      • East Horsley, Surrey, United Kingdom, KT24 6QT
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    • West Sussex
      • Crawley, West Sussex, United Kingdom, RH10 7DX
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  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Novartis Investigative Site
      • Birmingham, Alabama, United States, 35235
        • Novartis Investigative Site
      • Huntsville, Alabama, United States, 35801
        • Novartis Investigative Site
      • Mobile, Alabama, United States, 36608
        • Novartis Investigative Site
      • Mobile, Alabama, United States, 36617
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      • Montgomery, Alabama, United States, 36106
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      • Muscle Shoals, Alabama, United States, 35662
        • Novartis Investigative Site
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Novartis Investigative Site
      • Phoenix, Arizona, United States, 85032
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      • Tucson, Arizona, United States, 85741
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      • Tucson, Arizona, United States, 85712
        • Novartis Investigative Site
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Novartis Investigative Site
    • California
      • Burlingame, California, United States, 94010
        • Novartis Investigative Site
      • Fullerton, California, United States, 92835
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      • Huntington Beach, California, United States, 92648
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      • Oakland, California, United States, 94609
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      • Pasadena, California, United States, 91101
        • Novartis Investigative Site
      • Riverside, California, United States, 92501
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      • Spring Valley, California, United States, 91978-1522
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      • Torrance, California, United States, 90502
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      • Walnut Creek, California, United States, 94598
        • Novartis Investigative Site
    • Colorado
      • Denver, Colorado, United States, 80209
        • Novartis Investigative Site
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • Novartis Investigative Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Novartis Investigative Site
      • Boca Raton, Florida, United States, 33433
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      • Ft. Lauderdale, Florida, United States, 33311
        • Novartis Investigative Site
      • Hollywood, Florida, United States, 33021
        • Novartis Investigative Site
      • Jacksonville, Florida, United States, 32204
        • Novartis Investigative Site
      • Jacksonville, Florida, United States, 32205
        • Novartis Investigative Site
      • Jacksonville, Florida, United States, 32216
        • Novartis Investigative Site
      • Jacksonville, Florida, United States, 32209
        • Novartis Investigative Site
      • Lauderdale Lakes, Florida, United States, 33313
        • Novartis Investigative Site
      • Pensacola, Florida, United States, 32504
        • Novartis Investigative Site
      • Plantation, Florida, United States, 33324
        • Novartis Investigative Site
      • West Palm Beach, Florida, United States, 33401
        • Novartis Investigative Site
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Novartis Investigative Site
      • Augusta, Georgia, United States, 30909
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      • Augusta, Georgia, United States, 30904
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      • Cumming, Georgia, United States, 30041
        • Novartis Investigative Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Novartis Investigative Site
      • Honolulu, Hawaii, United States, 96814
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    • Illinois
      • Champaign, Illinois, United States, 61820
        • Novartis Investigative Site
      • Lake Zurich, Illinois, United States, 60047
        • Novartis Investigative Site
      • Peoria, Illinois, United States, 61615
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    • Kansas
      • Topeka, Kansas, United States, 66606
        • Novartis Investigative Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Novartis Investigative Site
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Novartis Investigative Site
      • Slidell, Louisiana, United States, 70458
        • Novartis Investigative Site
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Novartis Investigative Site
    • Massachusetts
      • Burlington, Massachusetts, United States, 01803
        • Novartis Investigative Site
      • Haverhill, Massachusetts, United States, 01830
        • Novartis Investigative Site
      • Jamaica Plain, Massachusetts, United States, 02130
        • Novartis Investigative Site
      • Natick, Massachusetts, United States, 01760
        • Novartis Investigative Site
      • North Dartmouth, Massachusetts, United States, 02747
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      • Waltham, Massachusetts, United States, 02154
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      • Worcester, Massachusetts, United States, 01609
        • Novartis Investigative Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Novartis Investigative Site
      • Detroit, Michigan, United States, 48202
        • Novartis Investigative Site
      • Detroit, Michigan, United States, 48236
        • Novartis Investigative Site
      • Kalamazoo, Michigan, United States, 49048
        • Novartis Investigative Site
      • Livonia, Michigan, United States, 48154
        • Novartis Investigative Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Novartis Investigative Site
      • Minneapolis, Minnesota, United States, 55404
        • Novartis Investigative Site
      • St. Louis Park, Minnesota, United States, 55416
        • Novartis Investigative Site
    • Mississippi
      • Belzoni, Mississippi, United States, 39038
        • Novartis Investigative Site
      • Gulfport, Mississippi, United States, 39501
        • Novartis Investigative Site
      • Jackson, Mississippi, United States, 39209
        • Novartis Investigative Site
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Novartis Investigative Site
      • St. Louis, Missouri, United States, 63141
        • Novartis Investigative Site
      • St. Louis, Missouri, United States, 63110-1093
        • Novartis Investigative Site
    • Nebraska
      • Fremont, Nebraska, United States, 68025
        • Novartis Investigative Site
      • Omaha, Nebraska, United States, 68131
        • Novartis Investigative Site
    • New Hampshire
      • Dover, New Hampshire, United States, 03820-2403
        • Novartis Investigative Site
    • New Jersey
      • Princeton Junction, New Jersey, United States, 08550
        • Novartis Investigative Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Novartis Investigative Site
    • New York
      • Albany, New York, United States, 12206
        • Novartis Investigative Site
      • Rochester, New York, United States, 14607
        • Novartis Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Novartis Investigative Site
      • Cleveland, Ohio, United States, 44115
        • Novartis Investigative Site
      • Lyndhurst, Ohio, United States, 44124
        • Novartis Investigative Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Novartis Investigative Site
      • Oklahoma City, Oklahoma, United States, 73112
        • Novartis Investigative Site
      • Tulsa, Oklahoma, United States, 74133
        • Novartis Investigative Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Novartis Investigative Site
      • Lancaster, Pennsylvania, United States, 17604
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      • Lansdale, Pennsylvania, United States, 19446
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      • Melrose Park, Pennsylvania, United States, 19027
        • Novartis Investigative Site
      • Philadelphia, Pennsylvania, United States, 19138
        • Novartis Investigative Site
      • Wyomissing, Pennsylvania, United States, 19610
        • Novartis Investigative Site
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Novartis Investigative Site
    • South Carolina
      • Aiken, South Carolina, United States, 29801
        • Novartis Investigative Site
      • Charleston, South Carolina, United States, 29425
        • Novartis Investigative Site
      • Columbia, South Carolina, United States, 29201
        • Novartis Investigative Site
      • Greenville, South Carolina, United States, 29605
        • Novartis Investigative Site
      • Orangeburg, South Carolina, United States, 29115
        • Novartis Investigative Site
    • Tennessee
      • Collierville, Tennessee, United States, 38017
        • Novartis Investigative Site
    • Texas
      • Amarillo, Texas, United States, 79106
        • Novartis Investigative Site
      • Austin, Texas, United States, 78731
        • Novartis Investigative Site
      • Dallas, Texas, United States, 75235
        • Novartis Investigative Site
      • Dallas, Texas, United States, 75226
        • Novartis Investigative Site
      • Dallas, Texas, United States, 75231
        • Novartis Investigative Site
      • Dallas, Texas, United States, 75390
        • Novartis Investigative Site
      • Houston, Texas, United States, 77030
        • Novartis Investigative Site
      • Irving, Texas, United States, 75039
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      • McAllen, Texas, United States, 78501
        • Novartis Investigative Site
      • North Richland Hills, Texas, United States, 76180
        • Novartis Investigative Site
      • Plano, Texas, United States, 75024
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      • San Antonio, Texas, United States, 78218
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      • San Antonio, Texas, United States, 78207
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      • San Antonio, Texas, United States, 78229-4801
        • Novartis Investigative Site
      • Temple, Texas, United States, 76508-0002
        • Novartis Investigative Site
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Novartis Investigative Site
      • Burlington, Vermont, United States, 05401
        • Novartis Investigative Site
    • Virginia
      • Alexandria, Virginia, United States, 22304-2315
        • Novartis Investigative Site
      • Burke, Virginia, United States, 22015
        • Novartis Investigative Site
    • Washington
      • Renton, Washington, United States, 98055
        • Novartis Investigative Site
    • West Virginia
      • Charleston, West Virginia, United States, 25301
        • Novartis Investigative Site
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • Novartis Investigative Site
  • Venezuela
    • Distrito Capital
      • Caracas, Distrito Capital, Venezuela, 1010
        • Novartis Investigative Site
      • Caracas, Distrito Capital, Venezuela, 1020
        • Novartis Investigative Site
      • Caracas, Distrito Capital, Venezuela, 1040
        • Novartis Investigative Site
      • Caracas, Distrito Capital, Venezuela, 1080-A
        • Novartis Investigative Site
      • Caracas, Distrito Capital, Venezuela, 1100
        • Novartis Investigative Site
    • Estado Bolívar
      • Puerto Ordaz, Estado Bolívar, Venezuela, 8050
        • Novartis Investigative Site
    • Estado Carabobo
      • Valencia, Estado Carabobo, Venezuela, 2001
        • Novartis Investigative Site
    • Estado Miranda
      • Caracas, Estado Miranda, Venezuela, 1060
        • 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

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes and at least one of the following:

    • Macroalbuminuria and an eGFR ≥30 mL/min/1.73 m2
    • Microalbuminuria and a reduced kidney function (eGFR eGFR ≥30 and <60 mL/min/1.73 m2)
    • A history of CV disease (previous MI, previous stroke, heart failure, coronary artery disease, history of percutaneous coronary intervention, angiography proven stenosis ≥50% in at least one coronary artery and a reduced kidney function (eGFR ≥30 and <60 mL/min/1.73 m2)
  • Concomitant treatment should follow national guidelines and must include either an Angiotensin-converting-enzyme-inhibitor (ACEi) or an Angiotensin-receptor-blocker (ARB) but not both.

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • Cardiovascular event or procedure ≤ 3 months prior to Visit 1
  • Unstable serum creatinine
  • Hypertension: Mean sitting systolic blood pressure (msSBP) ≥ 135 and < 170 mmHg or Mean sitting diastolic blood pressure (msDBP) ≥ 85 and < 110 mmHg unless treated with at least 3 anti-hypertensive medications
  • Hypertension msSBP ≥ 170 or msDBP ≥ 110 mmHg
  • Baseline Serum Potassium > 5.0 mmol/L
  • Patients who are treated with two renin-angiotensin-aldosterone-system-blockers
  • Patients with NYHA class III or IV heart failure
  • Known renal artery stenosis
  • Previous randomization into the AVOID trial (CSPP100C2201)

EXCLUSION SPECIFIC TO THE SAFETY FOLLOW-UP PERIOD:

- Aliskiren or aliskiren containing fixed combination products must not be used

Other protocol-defined inclusion/exclusion criteria applied

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aliskiren

In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.

With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment
Drug: Aliskiren
Aliskiren 150 mg film-coated tablets
Placebo Comparator: Placebo

In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.

With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
Drug: Placebo
Placebo to match aliskiren 150 mg film-coated tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Occurrence of Primary Composite Endpoint (Core : Active Treatment Phase)
Time Frame: Time from randomization to the first event (Maximum 50 months)

Occurrence was defined as the first event of the following composite primary endpoint:

  • Cardiovascular (CV) death
  • Resuscitated sudden death
  • Non-fatal myocardial infarction (MI)
  • Non-fatal stroke
  • Unplanned hospitalization for heart failure (HF)
  • Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.
  • Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.
Time from randomization to the first event (Maximum 50 months)
Percentage of Participants With Cardiovascular (CV) Death (Core: Active Treatment Phase)
Time Frame: Time from randomization to the first event (Maximum 50 months)
Time from randomization to the first event (Maximum 50 months)
Percentage of Participants With Resuscitated Sudden Death (Core: Active Treatment Phase)
Time Frame: Time from randomization to the first event (Maximum 50 Months)
Resuscitated sudden death was adjudicated when a subject experiences sudden death or cardiac arrest and is successfully resuscitated by cardioversion, defibrillation or cardiopulmonary resuscitation with a meaningful recovery of consciousness. This definition excludes known transient losses of consciousness such as seizure or vasovagal episodes that do not reflect significant cardiac dysfunction.
Time from randomization to the first event (Maximum 50 Months)
Percentage of Participants With Fatal/Non-fatal Myocardial Infarction (MI) (Core: Active Treatment Phase)
Time Frame: Time from randomization to the first event (Maximum 50 Months)
Time from randomization to the first event (Maximum 50 Months)
Percentage of Participants With Fatal/Non-fatal Stroke (Core: Active Treatment Phase)
Time Frame: Time from randomization to the first event (Maximum 50 Months)
Time from randomization to the first event (Maximum 50 Months)
Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Core: Active Treatment Phase)
Time Frame: Time from randomization to the first event (Maximum 50 Months)
ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death
Time from randomization to the first event (Maximum 50 Months)
Percentage of Participants With Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Core: Active Treatment Phase)
Time Frame: Time from randomization to the first event (Maximum 50 Months)
To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.
Time from randomization to the first event (Maximum 50 Months)
Percentage of Participants With Unplanned Hospitalization for Heart Failure (Core: Active Treatment Phase)
Time Frame: Time from randomization to the first event (Maximum 50 Months)
Time from randomization to the first event (Maximum 50 Months)
Percentage of Participants With All Cause Mortality (Core: Active Treatment Phase)
Time Frame: Time from randomization to the first event (Maximum 50 months)
Time from randomization to the first event (Maximum 50 months)
Percentage of Participants With Occurrence of Primary Composite Endpoint (Extension Phase)
Time Frame: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)

Occurrence was defined as the first event of the following composite primary endpoint:

  • Cardiovascular (CV) death
  • Resuscitated sudden death
  • Non-fatal myocardial infarction (MI)
  • Non-fatal stroke
  • Unplanned hospitalization for heart failure (HF)
  • Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.
  • Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.
From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)
Percentage of Participants With Cardiovascular (CV) Death (Extension Phase)
Time Frame: from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)
from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)
Percentage of Participants With Resuscitated Sudden Death (Extension Phase)
Time Frame: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)
From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)
Percentage of Participants Fatal/Non-fatal Myocardial Infarction (MI) (Extension Phase)
Time Frame: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 month in average)
From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 month in average)
Percentage of Participants With Fatal/Non-fatal Stroke (Extension Phase)
Time Frame: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)
From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)
Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Extension Phase)
Time Frame: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)
ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death
From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)
Percentage of Participants Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Extension Phase)
Time Frame: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)
To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.
From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)
Percentage of Participants With Unplanned Hospitalization for Heart Failure (Extension Phase)
Time Frame: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)
From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)
Percentage of Participants With All Cause Mortality (Extension Phase)
Time Frame: from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)
from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Occurrence of Secondary Cardiovascular Composite Endpoint (Core: Active Treatment Phase)
Time Frame: Time from randomization to the first event (Maximum 50 months)

Occurrence was defined as the first event of the following secondary cardiovascular composite endpoint:

  • Cardiovascular (CV) death
  • Resuscitated sudden death
  • Non-fatal myocardial infarction (MI)
  • Non-fatal stroke
  • Unplanned hospitalization for heart failure (HF)
Time from randomization to the first event (Maximum 50 months)
Percentage of Participants With Occurrence of Secondary Renal Composite Endpoint (Core: Active Treatment Phase)
Time Frame: Time from randomization to the first event (Maximum 50 months)

Occurrence was defined as the first event of the following secondary renal composite endpoint:

  • Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.
  • Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory.The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.
Time from randomization to the first event (Maximum 50 months)
Percentage of Participants With Occurrence of Secondary Cardiovascular Composite Endpoint (Extension Phase)
Time Frame: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)

Occurrence was defined as the first event of the following secondary cardiovascular composite endpoint:

  • Cardiovascular (CV) death
  • Resuscitated sudden death
  • Non-fatal myocardial infarction (MI)
  • Non-fatal stroke
  • Unplanned hospitalization for heart failure (HF)
From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)
Percentage of Participants With Occurrence of Secondary Renal Composite Endpoint (Extension Phase)
Time Frame: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)

Occurrence was defined as the first event of the following secondary renal composite endpoint:

  • Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.
  • Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.
From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Angioedema/Angioedema-like or Colorectal Events (Core : Active Treatment Phase)
Time Frame: Time from randomization to the first event (Maximum 50 months)
AEs of special interest were reported according to a post-marketing commitment to Health Authorities and included angioedema/angioedema-like events and colorectal events/ procedures
Time from randomization to the first event (Maximum 50 months)
Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR) to Month 6 and to Last Measurement (Core : Active Treatment Phase)
Time Frame: Baseline, Month 6 , last measurement (maximum at 50 months)

Baseline is the geometric mean of last 3 measurements before visit 3, Post-baseline value is the geometric mean of last 3 measurements during each visit.

Change from Baseline = Post - Baseline.
Baseline, Month 6 , last measurement (maximum at 50 months)
Mean Changes in Estimated Glomerular Filtration Rate (eGFR) From Baseline to Month 3 and Month 6 (Core : Active Treatment Phase)
Time Frame: Baseline to Month 3 and Month 6

The eGFR calculation was based on the Abbreviated Modification of Diet in Renal Disease (MDRD) Study Equation. Using this method, the applicable MDRD formula to calculate eGFR was as follows:

Estimated GFR (mL/min/1.73 m^2) = 175 x (serum creatinine in mg/dL) -1.154 x (Age in years) -0.203 x (0.742 if female) x (1.210 if Black)

Mean changes in eGFR from baseline to month 3 and month 6 were included for analysis. The LS Mean and Standard Error were based on an ANCOVA repeated-measure model with treatment, visit, treatment-by-visit and baseline eGFR as effect terms.
Baseline to Month 3 and Month 6
Percentage of Participants With Angioedema/Angioedema-like Events or Colorectal Events (Extension Phase)
Time Frame: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)
AEs of special interest were reported according to a post-marketing commitment to Health Authorities and included angioedema/angioedema-like events and colorectal events/ procedures.
From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

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General Publications

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

October 1, 2007

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

October 24, 2007

First Submitted That Met QC Criteria

October 25, 2007

First Posted (Estimate)

October 26, 2007

Study Record Updates

Last Update Posted (Estimate)

April 21, 2014

Last Update Submitted That Met QC Criteria

April 1, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

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Other Study ID Numbers

  • CSPP100E2337
  • 2007-000860-25 (EudraCT Number)

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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