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Registrational Study With Omecamtiv Mecarbil/AMG 423 to Treat Chronic Heart Failure With Reduced Ejection Fraction (GALACTIC-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02929329
Recruitment Status : Active, not recruiting
First Posted : October 11, 2016
Last Update Posted : July 17, 2019
Sponsor:
Collaborators:
Cytokinetics
Servier
Information provided by (Responsible Party):
Amgen

Brief Summary:
The purpose of this study is to determine if treatment with omecamtiv mecarbil/AMG 423 when added to standard of care is well tolerated and superior to placebo in reducing the risk of cardiovascular death or heart failure events in subjects with chronic HFrEF.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Omecamtiv Mecarbil Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction (GALACTIC-HF)
Actual Study Start Date : January 6, 2017
Estimated Primary Completion Date : February 7, 2021
Estimated Study Completion Date : February 7, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Active Treatment
Oral omecamtiv mecarbil twice daily for up to 208 weeks
Drug: Omecamtiv Mecarbil
Oral omecamtiv mecarbil twice daily for up to 208 weeks with dose level determined by periodic blood testing
Other Name: AMG 423

Placebo Comparator: Placebo
Oral placebo twice daily for up to 208 weeks
Drug: Placebo
Oral placebo twice daily for up to 208 weeks




Primary Outcome Measures :
  1. Measure time to cardiovascular death or first heart failure event [ Time Frame: Through study completion, up to 208 weeks ]
    Evaluate the effect of omecamtiv mecarbil/AMG 423 as compared with placebo in subjects with chronic heart failure with reduced ejection fraction receiving standard of care therapy


Secondary Outcome Measures :
  1. Measure time to cardiovascular death [ Time Frame: Through study completion, up to 208 weeks ]
    Evaluate effects of omecamtiv mecarbil/AMG 423 on time to cardiovascular death

  2. Measure changes in patient reported outcomes Kansas City Cardiomyopathy Questionnaire Total Symptom Score [ Time Frame: Week 24 ]
    Evaluate effect of treatment with omecamtiv mecarbil/AMG 423 on changes in patient reported outcomes

  3. Measure time to first heart failure hospitalization [ Time Frame: Through study completion, up to 208 weeks ]
    Evaluate effects of omecamtiv mecarbil/AMG 423 to first heart failure hospitalization

  4. Measure time to all-cause death [ Time Frame: Through study completion, up to 208 weeks ]
    Evaluate effects of omecamtiv mecarbil/AMG 423 to all-cause death


Other Outcome Measures:
  1. Subject incidence of reported adverse events [ Time Frame: Through study completion, up to 208 weeks ]
    Evaluate safety of omecamtiv mecarbil/AMG 423

  2. Subject incidence of reported serious adverse events of ventricular arrhythmias requiring treatment [ Time Frame: Through study completion, up to 208 weeks ]
    Evaluate safety of omecamtiv mecarbil/AMG 423

  3. Subject incidence of positively adjudicated major cardiac ischemic events [ Time Frame: Through study completion, up to 208 weeks ]
    Positively adjudicated major cardiac ischemic adverse events are: myocardial infarction, hospitalization for unstable angina, percutaneous coronary intervention/coronary artery bypass graft



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Subject has provided informed consent
  • Male or female, ≥ 18 to ≤ 85 years
  • History of chronic HF (defined as requiring treatment for HF for a minimum of 30 days before randomization)
  • LVEF ≤ 35%, per subjects most recent medical record, within 12 months prior to screening.
  • NYHA class II to IV at most recent screening assessment.
  • Managed with HF SoC therapies consistent with regional clinical practice guidelines according to investigator judgment of subject's clinical status
  • Current hospitalization with primary reason of HF OR one of the following events within 1 year of screening: hospitalization with primary reason of HF; urgent visit to emergency department (ED) with primary reason of HF.
  • Elevated BNP or NT-proBNP

Other Inclusion Criteria May apply

Key Exclusion Criteria:

  • Currently receiving treatment in another investigational device or drug study, or < 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
  • Malignancy within 5 years prior to randomization with the following exceptions: localized basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, stage 1 prostate carcinoma, breast ductal carcinoma in situ.
  • Subject has known sensitivity to any of the products or components to be administered during testing

Other Exclusion Criteria May apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02929329


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Feldkirch, Austria, 6807
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Graz, Austria, 8036
Research Site
Innsbruck, Austria, 6020
Research Site
Linz, Austria, 4010
Research Site
Linz, Austria, 4020
Research Site
Sankt Poelten, Austria, 3100
Research Site
Villach, Austria, 9500
Research Site
Wien, Austria, 1090
Research Site
Wien, Austria, 1160
Belgium
Research Site
Aalst, Belgium, 9300
Research Site
Genk, Belgium, 3600
Research Site
Gent, Belgium, 9000
Research Site
Leuven, Belgium, 3000
Research Site
Liège, Belgium, 4000
Research Site
Lodelinsart, Belgium, 6042
Research Site
Roeselare, Belgium, 8800
Brazil
Research Site
Brasilia, Distrito Federal, Brazil, 70673-900
Research Site
Goiania, Goiás, Brazil, 74223-130
Research Site
Goiania, Goiás, Brazil, 74605-020
Research Site
Belo Horizonte, Minas Gerais, Brazil, 30150-240
Research Site
Belo Horizonte, Minas Gerais, Brazil, 31110-580
Research Site
Uberlandia, Minas Gerais, Brazil, 38411-186
Research Site
Curitiba, Paraná, Brazil, 80045-170
Research Site
Curitiba, Paraná, Brazil, 80230-130
Research Site
Curitiba, Paraná, Brazil, 80730-150
Research Site
Londrina, Paraná, Brazil, 86038-350
Research Site
Natal, Rio Grande Do Norte, Brazil, 59020-035
Research Site
Canoas, Rio Grande Do Sul, Brazil, 92425-900
Research Site
Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
Research Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
Research Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Research Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90840-440
Research Site
Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200
Research Site
Aracaju, Sergipe, Brazil, 49055-530
Research Site
Campinas, São Paulo, Brazil, 13010-001
Research Site
Campinas, São Paulo, Brazil, 13060-080
Research Site
Campinas, São Paulo, Brazil, 13083-888
Research Site
Marilia, São Paulo, Brazil, 17515-000
Research Site
Ribeirao Preto, São Paulo, Brazil, 14048-900
Research Site
Sao Jose do Rio Preto, São Paulo, Brazil, 15015-770
Research Site
Sao Paulo, São Paulo, Brazil, 01317 002
Research Site
Sao Paulo, São Paulo, Brazil, 04005-000
Research Site
Sao Paulo, São Paulo, Brazil, 08270-120
Research Site
São José do Rio Preto, São Paulo, Brazil, 15090-000
Research Site
Rio De Janeiro, Brazil, 22271-100
Research Site
São Paulo, Brazil, 04012-909
Research Site
São Paulo, Brazil, 05403-000
Bulgaria
Research Site
Haskovo, Bulgaria, 6300
Research Site
Pleven, Bulgaria, 5800
Research Site
Sandanski, Bulgaria, 2800
Research Site
Sofia, Bulgaria, 1202
Research Site
Sofia, Bulgaria, 1233
Research Site
Sofia, Bulgaria, 1407
Research Site
Sofia, Bulgaria, 1527
Research Site
Sofia, Bulgaria, 1750
Canada, Alberta
Research Site
Edmonton, Alberta, Canada, T6G 2B7
Research Site
Edmonton, Alberta, Canada, T6K 4C1
Canada, British Columbia
Research Site
Kelowna, British Columbia, Canada, V1Y 1V6
Research Site
New Westminster, British Columbia, Canada, V3L 3W4
Research Site
North Vancouver, British Columbia, Canada, V7M 2H4
Canada, Manitoba
Research Site
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, New Brunswick
Research Site
Moncton, New Brunswick, Canada, E1G 1A7
Canada, Newfoundland and Labrador
Research Site
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Research Site
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Research Site
Brampton, Ontario, Canada, L6W 2X7
Research Site
Brampton, Ontario, Canada, L6Z 4N5
Research Site
Cambridge, Ontario, Canada, N1R 6V6
Research Site
London, Ontario, Canada, N6A 5A5
Research Site
Oshawa, Ontario, Canada, L1J 2J9
Research Site
Ottawa, Ontario, Canada, K1Y 4W7
Research Site
Peterborough, Ontario, Canada, K9J 0B2
Research Site
Scarborough, Ontario, Canada, M1P 2V5
Research Site
Sudbury, Ontario, Canada, P3E 5M4
Research Site
Toronto, Ontario, Canada, M5B 1W8
Research Site
Waterloo, Ontario, Canada, N2T 0C1
Canada, Quebec
Research Site
Chicoutimi, Quebec, Canada, G7H 7K9
Research Site
Greenfield Park, Quebec, Canada, J4V 2G8
Research Site
Laval, Quebec, Canada, H7M 3L9
Research Site
Montreal, Quebec, Canada, H1T 1C8
Research Site
Montreal, Quebec, Canada, H1T 3Y7
Research Site
Montreal, Quebec, Canada, H3G 1A4
Research Site
Montreal, Quebec, Canada, H4A 3J1
Research Site
Québec, Quebec, Canada, G1V 4G5
Research Site
St Jean sur Richelieu, Quebec, Canada, J3A 1J2
Research Site
St-Jérôme, Quebec, Canada, J7Z 5T3
Research Site
Terrebonne, Quebec, Canada, J6V 2H2
Chile
Research Site
Temuco, Cautín, Chile, 4781156
Research Site
Temuco, Cautín, Chile, 4813299
Research Site
Talcahuano, Concepción, Chile, 4270918
Research Site
San Miguel, Santiago, Chile, 8900085
Research Site
Vina del Mar, Valparaíso, Chile
Research Site
Osorno, Chile, 5311092
Research Site
Santiago, Chile, 7500739
Research Site
Santiago, Chile, 8207257
Research Site
Santiago, Chile, 8330034
Research Site
Santiago, Chile, 8350595
Research Site
Santiago, Chile, 8880300
Research Site
Santiago, Chile, 8910259
Research Site
Santiago, Chile
China, Beijing
Research Site
Beijing, Beijing, China, 100043
Research Site
Beijing, Beijing, China, 100191
China, Guangdong
Research Site
Guangzhou, Guangdong, China, 510080
Research Site
Guangzhou, Guangdong, China, 511400
China, Hainan
Research Site
Haikou, Hainan, China, 570102
China, Heilongjiang
Research Site
Harbin, Heilongjiang, China, 150001
China, Henan
Research Site
Luoyang, Henan, China, 471000
Research Site
Luoyang, Henan, China, 471009
Research Site
Xinxiang, Henan, China, 453000
Research Site
Zhengzhou, Henan, China, 450052
China, Hunan
Research Site
Hengyang, Hunan, China, 421001
Research Site
Xiangtan, Hunan, China, 411100
China, Inner Mongolia
Research Site
Huhehaote, Inner Mongolia, China, 010017
China, Jiangsu
Research Site
Nanjing, Jiangsu, China, 211100
Research Site
Suzhou, Jiangsu, China, 215000
Research Site
Wuxi, Jiangsu, China, 214023
Research Site
Xuzhou, Jiangsu, China, 221006
China, Jilin
Research Site
Changchun, Jilin, China, 130021
Research Site
Changchun, Jilin, China, 130033
China, Liaoning
Research Site
Shenyang, Liaoning, China, 110000
Research Site
Shenyang, Liaoning, China, 110004
Research Site
Shenyang, Liaoning, China, 110016
China, Shaanxi
Research Site
XI An, Shaanxi, China, 710061
China, Shandong
Research Site
Heze, Shandong, China, 274031
Research Site
Jinan, Shandong, China, 250012
Research Site
Jining, Shandong, China, 272009
Research Site
QingDao, Shandong, China, 266003
China, Shanxi
Research Site
Taiyuan, Shanxi, China, 030001
Research Site
Taiyuan, Shanxi, China, 030012
Research Site
Yuncheng, Shanxi, China, 044000
China, Tianjin
Research Site
Tianjin, Tianjin, China, 300052
China, Xinjiang
Research Site
Urumqi, Xinjiang, China, 830054
China, Zhejiang
Research Site
Hangzhou, Zhejiang, China, 310000
Research Site
Linhai, Zhejiang, China, 317000
Research Site
Ningbo, Zhejiang, China, 315010
China
Research Site
Beijing, China, 100020
Research Site
Beijing, China, 100037
Research Site
Shanghai, China, 200080
Colombia
Research Site
Medellin, Antioquia, Colombia, 05001000
Research Site
Medellin, Antioquia, Colombia, 050012
Research Site
Medellin, Antioquia, Colombia, 050021
Research Site
Medellin, Antioquia, Colombia, 050034
Research Site
Barranquilla, Atlántico, Colombia, 080020
Research Site
Barranquilla, Atlántico, Colombia
Research Site
Cartagena, Bolívar, Colombia, 130010
Research Site
Manizales, Caldas, Colombia
Research Site
Armenia, Quindío, Colombia, 630004
Research Site
Bucaramanga, Santander, Colombia, 680008
Research Site
Bucaramanga, Santander, Colombia, 681004
Research Site
Cali, Valle Del Cauca, Colombia, 760042
Research Site
Santiago de Cali, Valle Del Cauca, Colombia, 760032
Research Site
Bogota D.C., Colombia
Czechia
Research Site
Beroun, Czechia, 266 01
Research Site
Brandys nad Labem, Czechia, 250 01
Research Site
Brno, Czechia, 602 00
Research Site
Brno, Czechia, 625 00
Research Site
Brno, Czechia, 636 00
Research Site
Brno, Czechia, 656 91
Research Site
Frydek Mistek, Czechia, 738 01
Research Site
Havlickuv Brod, Czechia, 580 22
Research Site
Hradec Kralove, Czechia, 500 05
Research Site
Jihlava, Czechia, 586 33
Research Site
Karlovy Vary, Czechia, 360 01
Research Site
Kladno, Czechia, 272 59
Research Site
Klatovy IV, Czechia, 339 01
Research Site
Kolin III, Czechia, 280 02
Research Site
Liberec, Czechia, 460 63
Research Site
Louny, Czechia, 440 01
Research Site
Marianske Lazne, Czechia, 353 01
Research Site
Mohelnice, Czechia, 789 85
Research Site
Opava, Czechia, 746 01
Research Site
Ostrava, Czechia, 728 80
Research Site
Policka, Czechia, 572 01
Research Site
Praha 10, Czechia, 100 34
Research Site
Praha 1, Czechia, 110 00
Research Site
Praha 2, Czechia, 128 08
Research Site
Praha 5 - Smichov, Czechia, 150 00
Research Site
Pribram VIII, Czechia, 261 01
Research Site
Svitavy, Czechia, 568 25
Research Site
Teplice, Czechia, 415 01
Research Site
Uherske Hradiste, Czechia, 686 01
Research Site
Zlin, Czechia, 762 75
Research Site
Znojmo, Czechia, 669 02
Denmark
Research Site
Aalborg, Denmark, 9000
Research Site
Aarhus N, Denmark, 8200
Research Site
Esbjerg, Denmark, 6700
Research Site
Glostrup, Denmark, 2600
Research Site
Hellerup, Denmark, 2900
Research Site
Hillerod, Denmark, 3400
Research Site
Køge, Denmark, 4600
Research Site
Odense, Denmark, 5000
Research Site
Svendborg, Denmark, 5700
France
Research Site
Beziers cedex, France, 34525
Research Site
Caen Cedex 9, France, 14033
Research Site
Chambray les Tours, France, 37170
Research Site
Corbeil Essonnes, France, 91100
Research Site
Créteil Cedex, France, 94010
Research Site
Dijon, France, 21000
Research Site
Grenoble Cedex 9, France, 38043
Research Site
Le Chesnay, France, 78157
Research Site
Lille Cedex, France, 59037
Research Site
Lille, France, 59000
Research Site
Limoges Cedex, France, 87042
Research Site
Lyon Cedex 03, France, 69384
Research Site
Montauban, France, 82017
Research Site
Montpellier cedex 05, France, 34295
Research Site
Nantes Cedex 1, France, 44093
Research Site
Nantes Cedex 2, France, 44277
Research Site
Nimes cedex 9, France, 30029
Research Site
Paris Cedex 13, France, 75651
Research Site
Paris, France, 75010
Research Site
Paris, France, 75014
Research Site
Paris, France, 75018
Research Site
Pessac Cedex, France, 33604
Research Site
Poitiers, France, 86000
Research Site
Rennes Cedex 9, France, 35033
Research Site
Saint Denis, France, 93200
Research Site
Toulon Cedex, France, 83056
Research Site
Toulouse Cedex 9, France, 31059
Research Site
Tourcoing cedex, France, 59208
Research Site
Valenciennes, France, 59300
Germany
Research Site
Bad Neuheim, Germany, 61231
Research Site
Berlin, Germany, 13353
Research Site
Dortmund, Germany, 44137
Research Site
Düsseldorf, Germany, 40225
Research Site
Erfurt, Germany, 99089
Research Site
Erfurt, Germany, 99097
Research Site
Essen, Germany, 45147
Research Site
Frankfurt am Main, Germany, 65929
Research Site
Freiburg, Germany, 79106
Research Site
Greifswald, Germany, 17475
Research Site
Göttingen, Germany, 37075
Research Site
Haßloch, Germany, 67454
Research Site
Heidelberg, Germany, 69120
Research Site
Homburg, Germany, 66421
Research Site
Köln, Germany, 50937
Research Site
Langen, Germany, 63225
Research Site
Leipzig, Germany, 04289
Research Site
Ludwigshafen, Germany, 67063
Research Site
Mainz, Germany, 55131
Research Site
Markleeberg, Germany, 04416
Research Site
Witten, Germany, 58455
Research Site
Würzburg, Germany, 97078
Greece
Research Site
Alexandroupoli, Greece, 68100
Research Site
Athens, Greece, 11527
Research Site
Athens, Greece, 14233
Research Site
Athens, Greece, 16673
Research Site
Chaidari, Athens, Greece, 12462
Research Site
Chalkida, Greece, 34100
Research Site
Heraklion, Greece, 71110
Research Site
Ioannina, Greece, 45500
Research Site
Larissa, Greece, 41110
Research Site
Thessaloniki, Greece, 54636
Research Site
Thessaloniki, Greece, 56403
Hungary
Research Site
Balatonfured, Hungary, 8230
Research Site
Bekescsaba, Hungary, 5600
Research Site
Berettyoujfalu, Hungary, 4100
Research Site
Budapest, Hungary, 1023
Research Site
Budapest, Hungary, 1037
Research Site
Budapest, Hungary, 1085
Research Site
Budapest, Hungary, 1096
Research Site
Budapest, Hungary, 1122
Research Site
Budapest, Hungary, 1125
Research Site
Budapest, Hungary, 1134
Research Site
Cegled, Hungary, 2700
Research Site
Dunaujvaros, Hungary, 2400
Research Site
Gyongyos, Hungary, 3200
Research Site
Gyula, Hungary, 5700
Research Site
Kaposvar, Hungary, 7400
Research Site
Komarom, Hungary, 2921
Research Site
Nyiregyhaza, Hungary, 4400
Research Site
Pecs, Hungary, 7624
Research Site
Sopron, Hungary, 9400
Research Site
Szeged, Hungary, 6725
Research Site
Szekszard, Hungary, 7100
Research Site
Szentes, Hungary, 6600
Research Site
Szolnok, Hungary, 5004
Research Site
Zalaegerszeg, Hungary, 8900
Italy
Research Site
Ariccia, Italy, 00072
Research Site
Arzignano, Italy, 36071
Research Site
Bergamo, Italy, 24127
Research Site
Bologna, Italy, 40139
Research Site
Brescia, Italy, 25123
Research Site
Cagliari, Italy, 09134
Research Site
Catania, Italy, 95123
Research Site
Catanzaro, Italy, 88100
Research Site
Cona FE, Italy, 44124
Research Site
Cuneo, Italy, 12100
Research Site
Foggia, Italy, 71100
Research Site
Milano, Italy, 20132
Research Site
Milano, Italy, 20138
Research Site
Milano, Italy, 20162
Research Site
Monza (MB), Italy, 20900
Research Site
Monza, Italy, 20900
Research Site
Napoli, Italy, 80131
Research Site
Palermo, Italy, 90146
Research Site
Pavia, Italy, 27100
Research Site
Perugia, Italy, 06156
Research Site
Piacenza, Italy, 29121
Research Site
Rimini, Italy, 47923
Research Site
Roma, Italy, 00163
Research Site
Rozzano MI, Italy, 20089
Research Site
Seriate, Italy, 24068
Research Site
Siena, Italy, 53100
Research Site
Torrette Di Ancona, Italy, 60126
Research Site
Trieste, Italy, 34149
Research Site
Vimercate MB, Italy, 20871
Japan
Research Site
Ichinomiya-shi, Aichi, Japan, 491-8551
Research Site
Nagakute-shi, Aichi, Japan, 480-1195
Research Site
Nagoya-shi, Aichi, Japan, 454-8509
Research Site
Nagoya-shi, Aichi, Japan, 466-8560
Research Site
Seto-shi, Aichi, Japan, 489-8642
Research Site
Asahi-shi, Chiba, Japan, 289-2511
Research Site
Chiba-shi, Chiba, Japan, 260-8606
Research Site
Funabashi-shi, Chiba, Japan, 273-8588
Research Site
Urayasu-shi, Chiba, Japan, 279-0021
Research Site
Imabari-shi, Ehime, Japan, 794-0006
Research Site
Matsuyama-shi, Ehime, Japan, 790-0067
Research Site
Chikushino-shi, Fukuoka, Japan, 818-8516
Research Site
Fukuoka-shi, Fukuoka, Japan, 810-0001
Research Site
Fukuoka-shi, Fukuoka, Japan, 810-8539
Research Site
Fukuoka-shi, Fukuoka, Japan, 811-0213
Research Site
Fukuoka-shi, Fukuoka, Japan, 812-0033
Research Site
Fukuoka-shi, Fukuoka, Japan, 814-0180
Research Site
Fukuoka-shi, Fukuoka, Japan, 815-8555
Research Site
Fukuoka-shi, Fukuoka, Japan, 815-8588
Research Site
Kasuya-gun, Fukuoka, Japan, 811-2316
Research Site
Kitakyushu-shi, Fukuoka, Japan, 802-0077
Research Site
Kitakyushu-shi, Fukuoka, Japan, 802-8555
Research Site
Kitakyushu-shi, Fukuoka, Japan, 805-8508
Research Site
Koga-shi, Fukuoka, Japan, 811-3195
Research Site
Kurume-shi, Fukuoka, Japan, 830-8577
Research Site
Kurume-shi, Fukuoka, Japan, 839-0863
Research Site
Onga-gun, Fukuoka, Japan, 807-0051
Research Site
Fukushima-shi, Fukushima, Japan, 960-1295
Research Site
Fukushima-shi, Fukushima, Japan, 960-8251
Research Site
Fukushima-shi, Fukushima, Japan, 960-8530
Research Site
Ogaki-shi, Gifu, Japan, 503-8502
Research Site
Maebashi-shi, Gunma, Japan, 371-8511
Research Site
Takasaki-shi, Gunma, Japan, 370-0829
Research Site
Fukuyama-shi, Hiroshima, Japan, 721-8511
Research Site
Hiroshima-shi, Hiroshima, Japan, 734-8551
Research Site
Kure-shi, Hiroshima, Japan, 737-0023
Research Site
Hakodate-shi, Hokkaido, Japan, 041-8512
Research Site
Sapporo-shi, Hokkaido, Japan, 063-0005
Research Site
Amagasaki-shi, Hyogo, Japan, 660-8550
Research Site
Himeji-shi, Hyogo, Japan, 670-0981
Research Site
Kawanishi-shi, Hyogo, Japan, 666-0125
Research Site
Nishinomiya-shi, Hyogo, Japan, 663-8501
Research Site
Takarazuka-shi, Hyogo, Japan, 665-0873
Research Site
Higashiibaraki-gun, Ibaraki, Japan, 311-3193
Research Site
Kahoku-gun, Ishikawa, Japan, 920-0293
Research Site
Kanazawa-shi, Ishikawa, Japan, 920-8650
Research Site
Morioka-shi, Iwate, Japan, 020-0066
Research Site
Takamatsu-shi, Kagawa, Japan, 760-8557
Research Site
Hayama, Kanagawa, Japan, 240-0116
Research Site
Kawasaki-shi, Kanagawa, Japan, 210-0852
Research Site
Kawasaki-shi, Kanagawa, Japan, 211-8533
Research Site
Kawasaki-shi, Kanagawa, Japan, 216-8511
Research Site
Odawara-shi, Kanagawa, Japan, 250-8558
Research Site
Sagamihara-shi, Kanagawa, Japan, 252-0392
Research Site
Sagamihara-shi, Kanagawa, Japan, 252-5188
Research Site
Yokohama-shi, Kanagawa, Japan, 227-8501
Research Site
Yokohama-shi, Kanagawa, Japan, 231-8682
Research Site
Yokohama-shi, Kanagawa, Japan, 247-8581
Research Site
Nankoku-shi, Kochi, Japan, 783-8505
Research Site
Kumamoto-shi, Kumamoto, Japan, 861-4193
Research Site
Sendai-shi, Miyagi, Japan, 980-8574
Research Site
Nagano-shi, Nagano, Japan, 381-8551
Research Site
Kashihara-shi, Nara, Japan, 634-8522
Research Site
Oita-shi, Oita, Japan, 870-0192
Research Site
Okayama-shi, Okayama, Japan, 700-8558
Research Site
Naha-shi, Okinawa, Japan, 902-8511
Research Site
Shimajiri-gun, Okinawa, Japan, 901-0493
Research Site
Urasoe-shi, Okinawa, Japan, 901-2132
Research Site
Higashiosaka-shi, Osaka, Japan, 579-8056
Research Site
Matsubara-shi, Osaka, Japan, 580-0032
Research Site
Osaka-shi, Osaka, Japan, 530-0001
Research Site
Osaka-shi, Osaka, Japan, 533-0024
Research Site
Osaka-shi, Osaka, Japan, 540-0006
Research Site
Osaka-shi, Osaka, Japan, 556-0017
Research Site
Osaka-shi, Osaka, Japan, 559-0012
Research Site
Suita-shi, Osaka, Japan, 565-0871
Research Site
Saga-shi, Saga, Japan, 849-8501
Research Site
Ureshino-shi, Saga, Japan, 843-0301
Research Site
Ageo-shi, Saitama, Japan, 362-8588
Research Site
Koshigaya-shi, Saitama, Japan, 343-8577
Research Site
Wako-shi, Saitama, Japan, 351-0102
Research Site
Kusatsu-shi, Shiga, Japan, 525-8585
Research Site
Sunto-gun, Shizuoka, Japan, 411-8611
Research Site
Akishima-shi, Tokyo, Japan, 196-0003
Research Site
Bunkyo-ku, Tokyo, Japan, 113-8519
Research Site
Bunkyo-ku, Tokyo, Japan, 113-8603
Research Site
Chuo-ku, Tokyo, Japan, 104-8560
Research Site
Fussa-shi, Tokyo, Japan, 197-8511
Research Site
Hachioji-shi, Tokyo, Japan, 192-0918
Research Site
Itabashi-ku, Tokyo, Japan, 173-8610
Research Site
Kodaira-shi, Tokyo, Japan, 187-8510
Research Site
Meguro-ku, Tokyo, Japan, 152-8902
Research Site
Minato-ku, Tokyo, Japan, 108-8642
Research Site
Shinagawa-ku, Tokyo, Japan, 140-8522
Research Site
Shinjuku-ku, Tokyo, Japan, 162-8655
Research Site
Toyama-shi, Toyama, Japan, 939-8511
Lithuania
Research Site
Kaunas, Lithuania, 50009
Research Site
Klaipeda, Lithuania, 92288
Research Site
Vilnius, Lithuania, 08661
Research Site
Vilnius, Lithuania, 08861
Mexico
Research Site
Torreon, Coahuila, Mexico, 27000
Research Site
Mexico City, Distrito Federal, Mexico, 06700
Research Site
Mexico City, Distrito Federal, Mexico, 14080
Research Site
Mexico, Distrito Federal, Mexico, 11650
Research Site
Pachuca, Hidalgo, Mexico, 42070
Research Site
Guadalajara, Jalisco, Mexico, 44280
Research Site
Guadalajara, Jalisco, Mexico, 44340
Research Site
Guadalajara, Jalisco, Mexico, 44670
Research Site
Zapopan, Jalisco, Mexico, 45030
Research Site
Monterrey, Nuevo León, Mexico, 64060
Research Site
Monterrey, Nuevo León, Mexico, 64460
Research Site
Queretaro, Querétaro, Mexico, 76000
Research Site
San Luis Potosi, San Luis Potosí, Mexico, 78200
Research Site
Culiacan, Sinaloa, Mexico, 80230
Research Site
Xalapa, Veracruz, Mexico, 91193
Research Site
Aguascalientes, Mexico, 20230
Netherlands
Research Site
's Hertogenbosch, Netherlands, 5223 GZ
Research Site
Almelo, Netherlands, 7609 PP
Research Site
Arnhem, Netherlands, 6815 AD
Research Site
Breda, Netherlands, 4818 CK
Research Site
Capelle Aan De IJssel, Netherlands, 2906 ZC
Research Site
Den Helder, Netherlands, 1782 GZ
Research Site
Deventer, Netherlands, 7416 SE
Research Site
Doetinchem, Netherlands, 7009 BL
Research Site
Emmen, Netherlands, 7824 AA
Research Site
Goes, Netherlands, 4462 RA
Research Site
Groningen, Netherlands, 9713 GZ
Research Site
Groningen, Netherlands, 9728 NT
Research Site
Leiderdorp, Netherlands, 2353 GA
Research Site
Nijmegen, Netherlands, 6532 SZ
Research Site
Tiel, Netherlands, 4002 WP
Research Site
Tilburg, Netherlands, 5022 GC
Research Site
Tilburg, Netherlands, 5042 AD
Research Site
Uden, Netherlands, 5406 PT
Research Site
Zwolle, Netherlands, 8025 AB
New Zealand
Research Site
Christchurch, New Zealand, 8011
Research Site
Papatoetoe, Auckland, New Zealand, 2025
Research Site
Takapuna, Auckland, New Zealand, 0620
Poland
Research Site
Bialystok, Poland, 15-276
Research Site
Bytom, Poland, 41-902
Research Site
Gdansk, Poland, 80-262
Research Site
Gdynia, Poland, 81-157
Research Site
Gdynia, Poland, 81-423
Research Site
Gizycko, Poland, 11-500
Research Site
Kazimierza Wielka, Poland, 28-500
Research Site
Kielce, Poland, 25-736
Research Site
Klodzko, Poland, 57-300
Research Site
Krakow, Poland, 30-069
Research Site
Krakow, Poland, 30-082
Research Site
Krakow, Poland, 31-202
Research Site
Lodz, Poland, 90-549
Research Site
Lodz, Poland, 91-347
Research Site
Lodz, Poland, 92-213
Research Site
Lublin, Poland, 20-078
Research Site
Lublin, Poland, 20-857
Research Site
Miechow, Poland, 32-200
Research Site
Olawa, Poland, 55-200
Research Site
Piotrkow Trybunalski, Poland, 97-300
Research Site
Poznan, Poland, 61-848
Research Site
Ruda Slaska, Poland, 41-709
Research Site
Skierniewice, Poland, 96-100
Research Site
Stalowa Wola, Poland, 37-450
Research Site
Swidnik, Poland, 21-040
Research Site
Tarnow, Poland, 33-100
Research Site
Torun, Poland, 87-100
Research Site
Warszawa, Poland, 02-097
Research Site
Warszawa, Poland, 04-628
Research Site
Wloclawek, Poland, 87-800
Research Site
Wroclaw, Poland, 51-124
Research Site
Zabrze, Poland, 41-800
Portugal
Research Site
Aveiro, Portugal, 3814-501
Research Site
Coimbra, Portugal, 3000-075
Research Site
Covilha, Portugal, 6200-251
Research Site
Guimaraes, Portugal, 4835-044
Research Site
Lisboa, Portugal, 1449-005
Research Site
Lisboa, Portugal, 1500-650
Research Site
Lisboa, Portugal, 1649-035
Research Site
Setubal, Portugal, 2910-446
Puerto Rico
Research Site
San Juan, Puerto Rico, 00926-2832
Romania
Research Site
Bucarest, Romania, 014461
Research Site
Bucharest, Romania, 050098
Research Site
Bucuresti, Romania, 021659
Research Site
Bucuresti, Romania, 022322
Research Site
Cluj-Napoca, Romania, 400347
Research Site
Craiova, Romania, 200383
Research Site
Craiova, Romania, 200642
Research Site
Iasi, Romania, 700661
Research Site
Iasi, Romania, 700732
Research Site
Oradea, Romania, 410169
Research Site
Pitesti, Romania, 110438
Research Site
Targoviste, Romania, 130095
Research Site
Targu Mures, Romania, 540143
Research Site
Timisoara, Romania, 300079
Russian Federation
Research Site
Arkhangelsk, Russian Federation, 163001
Research Site
Barnaul, Russian Federation, 656038
Research Site
Ekaterinburg, Russian Federation, 620102
Research Site
Ivanovo, Russian Federation, 153012
Research Site
Izhevsk, Russian Federation, 426063
Research Site
Kemerovo, Russian Federation, 650002
Research Site
Kemerovo, Russian Federation, 650099
Research Site
Kirov, Russian Federation, 610014
Research Site
Korolev, Russian Federation, 141060
Research Site
Krasnodar, Russian Federation, 350086
Research Site
Lomonosov, Russian Federation, 198412
Research Site
Moscow, Russian Federation, 101990
Research Site
Moscow, Russian Federation, 117292
Research Site
Moscow, Russian Federation, 119192
Research Site
Moscow, Russian Federation, 121552
Research Site
Moscow, Russian Federation, 123182
Research Site
Moscow, Russian Federation, 127299
Research Site
Moscow, Russian Federation, 129090
Research Site
Moscow, Russian Federation, 129327
Research Site
Nizhniy Novgorod, Russian Federation, 603076
Research Site
Nizhny Novgorod, Russian Federation, 603126
Research Site
Novosibirsk, Russian Federation, 630008
Research Site
Novosibirsk, Russian Federation, 630087
Research Site
Novosibirsk, Russian Federation, 630089
Research Site
Omsk, Russian Federation, 644018
Research Site
Saint Petersburg, Russian Federation, 194156
Research Site
Saint Petersburg, Russian Federation, 195112
Research Site
Saint Petersburg, Russian Federation, 197022
Research Site
Saint Petersburg, Russian Federation, 198205
Research Site
Saint-Petersburg, Russian Federation, 192242
Research Site
Saint-Petersburg, Russian Federation, 196601
Research Site
Saint-Petersburg, Russian Federation, 197022
Research Site
Saint-Petersburg, Russian Federation, 199106
Research Site
Saratov, Russian Federation, 410054
Research Site
St. Petersburg, Russian Federation, 191015
Research Site
Tomsk, Russian Federation, 634012
Research Site
Village Novoseltsy, Russian Federation, 214016
Research Site
Vladimir, Russian Federation, 600020
Research Site
Yaroslavl, Russian Federation, 150030
Slovakia
Research Site
Banska Bystrica, Slovakia, 974 01
Research Site
Bardejov, Slovakia, 085 01
Research Site
Bratislava, Slovakia, 811 08
Research Site
Bratislava, Slovakia, 826 06
Research Site
Bratislava, Slovakia, 833 48
Research Site
Brezno, Slovakia, 977 42
Research Site
Kosice, Slovakia, 040 01
Research Site
Levice, Slovakia, 934 01
Research Site
Nitra, Slovakia, 950 01
Research Site
Presov, Slovakia, 080 01
Research Site
Rimavska Sobota, Slovakia, 979 01
Research Site
Snina, Slovakia, 069 01
Research Site
Svidnik, Slovakia, 089 01
Research Site
Trnava, Slovakia, 917 75
South Africa
Research Site
Bloemfontein, Free State, South Africa, 9301
Research Site
Parktown, Gauteng, South Africa, 2193
Research Site
Soweto, Gauteng, South Africa, 2013
Research Site
Sunninghill, Gauteng, South Africa, 2157
Research Site
Durban, KwaZulu-Natal, South Africa, 4001
Research Site
Umhlanga, KwaZulu-Natal, South Africa, 4320
Research Site
Parow, Western Cape, South Africa, 7505
Research Site
Somerset West, Western Cape, South Africa, 7130
Research Site
Worcester, Western Cape, South Africa, 6850
Spain
Research Site
Cordoba, Andalucía, Spain, 14004
Research Site
Granada, Andalucía, Spain, 18014
Research Site
Malaga, Andalucía, Spain, 29010
Research Site
Sevilla, Andalucía, Spain, 41009
Research Site
Ubeda, Andalucía, Spain, 23400
Research Site
Zaragoza, Aragón, Spain, 50009
Research Site
Oviedo, Asturias, Spain, 33011
Research Site
La laguna, Canarias, Spain, 38320
Research Site
Santander, Cantabria, Spain, 39008
Research Site
Valladolid, Castilla León, Spain, 47005
Research Site
Barcelona, Cataluña, Spain, 08041
Research Site
Alicante, Comunidad Valenciana, Spain, 03010
Research Site
Valencia, Comunidad Valenciana, Spain, 46010
Research Site
Valencia, Comunidad Valenciana, Spain, 46026
Research Site
A Coruña, Galicia, Spain, 15006
Research Site
Santiago de Compostela, Galicia, Spain, 15706
Research Site
Vigo, Galicia, Spain, 36312
Research Site
Majadahonda, Madrid, Spain, 28222
Research Site
El Palmar, Murcia, Spain, 30120
Research Site
Madrid, Spain, 28007
Research Site
Madrid, Spain, 28040
Research Site
Madrid, Spain, 28041
Sweden
Research Site
Falun, Sweden, 791 82
Research Site
Jonkoping, Sweden, 553 05
Research Site
Lidköping, Sweden, 531 85
Research Site
Linkoping, Sweden, 581 85
Research Site
Lund, Sweden, 222 21
Research Site
Orebro, Sweden, 701 85
Research Site
Skelleftea, Sweden, 931 86
Switzerland
Research Site
Basel, Switzerland, 4031
Research Site
Bern, Switzerland, 3010
Research Site
Fribourg, Switzerland, 1708
Research Site
Geneva 14, Switzerland, 1211
Research Site
Lausanne, Switzerland, 1011
Research Site
Lugano, Switzerland, 6900
Research Site
Zurich, Switzerland, 8032
Turkey
Research Site
Adana, Turkey, 01330
Research Site
Afyonkarahisar, Turkey, 03218
Research Site
Ankara, Turkey, 06100
Research Site
Ankara, Turkey, 06490
Research Site
Corum, Turkey, 19040
Research Site
Eskisehir, Turkey, 26040
Research Site
Istanbul, Turkey, 34096
Research Site
Istanbul, Turkey, 34098
Research Site
Istanbul, Turkey, 34200
Research Site
Istanbul, Turkey, 34865
Research Site
Izmir, Turkey, 35100
Research Site
Izmir, Turkey, 35340
Research Site
Kirikkale, Turkey, 71100
Research Site
Kocaeli, Turkey, 41380
Research Site
Konya, Turkey, 42080
Research Site
Mersin, Turkey, 33343
Research Site
Sakarya, Turkey, 54100
Research Site
Sivas, Turkey, 58140
Research Site
Van, Turkey, 65100
Ukraine
Research Site
Dnipropetrovsk, Ukraine, 49060
Research Site
Ivano-Frankivsk, Ukraine, 76018
Research Site
Kharkiv, Ukraine, 61002
Research Site
Kharkiv, Ukraine, 61018
Research Site
Kharkiv, Ukraine, 61039
Research Site
Kharkiv, Ukraine, 61106
Research Site
Kharkiv, Ukraine, 61176
Research Site
Kyiv, Ukraine, 01601
Research Site
Kyiv, Ukraine, 02091
Research Site
Kyiv, Ukraine, 02232
Research Site
Kyiv, Ukraine, 02660
Research Site
Kyiv, Ukraine, 03151
Research Site
Kyiv, Ukraine, 03680
Research Site
Lutsk, Ukraine, 43024
Research Site
Uzhgorod, Ukraine, 88014
Research Site
Vinnytsia, Ukraine, 21018
Research Site
Vinnytsia, Ukraine, 21029
Research Site
Vinnytsya, Ukraine, 21001
Research Site
Zaporizhzhia, Ukraine, 69035
Research Site
Zaporizhzhya, Ukraine, 69600
United Kingdom
Research Site
Ayr, United Kingdom, KA6 6DX
Research Site
Basingstoke, United Kingdom, RG24 9NA
Research Site
Belfast, United Kingdom, BT16 1RH
Research Site
Blackpool, United Kingdom, FY3 8NR
Research Site
Corby, United Kingdom, NN17 2UR
Research Site
Cottingham, United Kingdom, HU16 5JQ
Research Site
Dudley, United Kingdom, DY1 2HQ
Research Site
Dundee, United Kingdom, DD1 9SY
Research Site
Exeter, United Kingdom, EX2 5DW
Research Site
Gillingham, United Kingdom, ME7 5NY
Research Site
Glasgow, United Kingdom, G75 8RG
Research Site
Harlow, United Kingdom, CM20 1QX
Research Site
High Wycombe, United Kingdom, HP11 2TT
Research Site
London, United Kingdom, N18 1QX
Research Site
London, United Kingdom, SW3 6NP
Research Site
London, United Kingdom, W12 0HS
Research Site
Merthyr Tydfil, United Kingdom, CF47 9DT
Research Site
Newport, United Kingdom, PO30 5TG
Research Site
Northampton, United Kingdom, NN1 5BD
Research Site
Northwood, United Kingdom, HA6 2RN
Research Site
Norwich, United Kingdom, NR4 7UY
Research Site
Peterborough, United Kingdom, PE3 9GZ
Research Site
Portsmouth, United Kingdom, PO6 3LY
Research Site
Romford, United Kingdom, RM1 3PJ
Research Site
Sheffield, United Kingdom, S5 7AU
Research Site
Shipley, United Kingdom, BD18 3SA
Research Site
Sidcup, United Kingdom, DA14 6LT
Research Site
Solihull, United Kingdom, B91 2JL
Research Site
Stevenage, United Kingdom, SG1 4AB
Research Site
Sunderland, United Kingdom, SR4 7TP
Research Site
Swindon, United Kingdom, SN3 6BB
Research Site
Taunton, United Kingdom, TA1 5DA
Research Site
Torquay, United Kingdom, TQ2 7AA
Research Site
Worcester, United Kingdom, WR5 1DD
Sponsors and Collaborators
Amgen
Cytokinetics
Servier
Investigators
Layout table for investigator information
Study Director: MD Amgen

Additional Information:
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02929329     History of Changes
Other Study ID Numbers: 20110203
2016-002299-28 ( EudraCT Number )
First Posted: October 11, 2016    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
URL: https://www.amgen.com/datasharing
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases