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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02929329




Registration number
NCT02929329
Ethics application status
Date submitted
30/09/2016
Date registered
11/10/2016

Titles & IDs
Public title
Registrational Study With Omecamtiv Mecarbil (AMG 423) to Treat Chronic Heart Failure With Reduced Ejection Fraction
Scientific 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)
Secondary ID [1] 0 0
2016-002299-28
Secondary ID [2] 0 0
20110203
Universal Trial Number (UTN)
Trial acronym
GALACTIC-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Omecamtiv Mecarbil
Treatment: Drugs - Placebo
Treatment: Drugs - Standard of Care

Experimental: Omecamtiv Mecarbil - Participants received oral omecamtiv mecarbil (OM) twice daily in addition to standard heart failure therapy. The starting dose of OM was 25 mg; At week 4, participants with week 2 OM predose plasma concentrations \< 200 ng/mL had their dose increased to 50 mg BID; participants with week 2 predose plasma concentrations = 200 and \< 300 ng/mL had their dose increased to 37.5 mg BID and participants with week 2 predose plasma concentrations = 300 ng/mL and \< 1000 ng/mL maintained a 25 mg BID dosing regimen.

Placebo comparator: Placebo - Participants received matching placebo tablets twice a day in addition to standard heart failure therapy.


Treatment: Drugs: Omecamtiv Mecarbil
Omecamtiv mecarbil tablets for oral administration

Treatment: Drugs: Placebo
Matching placebo tablets

Treatment: Drugs: Standard of Care
Participants were required to be optimally managed with standard of care therapies for chronic HF (eg, beta blockers, renin angiotensin aldosterone system inhibitors), consistent with regional clinical practice guidelines, unless contraindicated.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Cardiovascular Death or First Heart Failure Event
Timepoint [1] 0 0
From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.
Secondary outcome [1] 0 0
Time to Cardiovascular Death
Timepoint [1] 0 0
From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.
Secondary outcome [2] 0 0
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ TSS) at Week 24
Timepoint [2] 0 0
Baseline and Week 24
Secondary outcome [3] 0 0
Time to First Heart Failure Hospitalization
Timepoint [3] 0 0
From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.
Secondary outcome [4] 0 0
Time to All-cause Death
Timepoint [4] 0 0
From randomization up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.

Eligibility
Key inclusion criteria
Key

* Subject has provided informed consent
* Male or female, = 18 to = 85 years
* History of chronic heart failure (HF), defined as requiring treatment for HF for a minimum of 30 days before randomization
* Left ventricle ejection fraction (LVEF) = 35%, per subjects most recent medical record, within 12 months prior to screening.
* New York Heart Association (NYHA) class II to IV at most recent screening assessment.
* Managed with HF standard of care (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 B-type natriuretic peptide (BNP) or n-terminal-prohormone brain natriuretic peptide (NT-proBNP)

Other Inclusion Criteria May apply

Key
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/09/2020
Sample size
Target
Accrual to date
Final
8256
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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2139 - Concord
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2010 - Darlinghurst
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State/province [200] 0 0
Markleeberg
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Germany
State/province [201] 0 0
Witten
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Germany
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Würzburg
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Greece
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Alexandroupoli
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Greece
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Athens
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Greece
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Chaidari, Athens
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Greece
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Chalkida
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Greece
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Heraklion
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Greece
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Ioannina
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Greece
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Larissa
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Greece
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Thessaloniki
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Hungary
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Balatonfured
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Hungary
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Bekescsaba
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Hungary
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Berettyoujfalu
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Hungary
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Budapest
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Hungary
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Cegled
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Hungary
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Dunaujvaros
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Hungary
State/province [217] 0 0
Gyongyos
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Hungary
State/province [218] 0 0
Gyula
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Hungary
State/province [219] 0 0
Kaposvar
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Hungary
State/province [220] 0 0
Komarom
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Hungary
State/province [221] 0 0
Nyiregyhaza
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Hungary
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Pecs
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Hungary
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Sopron
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Hungary
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Szeged
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Hungary
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Szekszard
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Hungary
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Szentes
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Hungary
State/province [227] 0 0
Szolnok
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Hungary
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Zalaegerszeg
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Italy
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Ariccia
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Italy
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Arzignano
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Italy
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Bergamo
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Italy
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Bologna
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Italy
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Brescia
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Italy
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Cagliari
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Italy
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Catania
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Italy
State/province [236] 0 0
Catanzaro
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Italy
State/province [237] 0 0
Cona FE
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Italy
State/province [238] 0 0
Cuneo
Country [239] 0 0
Italy
State/province [239] 0 0
Foggia
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Italy
State/province [240] 0 0
Milano
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Italy
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Monza (MB)
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Italy
State/province [242] 0 0
Monza
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Italy
State/province [243] 0 0
Napoli
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Italy
State/province [244] 0 0
Palermo
Country [245] 0 0
Italy
State/province [245] 0 0
Pavia
Country [246] 0 0
Italy
State/province [246] 0 0
Perugia
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Italy
State/province [247] 0 0
Piacenza
Country [248] 0 0
Italy
State/province [248] 0 0
Rimini
Country [249] 0 0
Italy
State/province [249] 0 0
Roma
Country [250] 0 0
Italy
State/province [250] 0 0
Rozzano MI
Country [251] 0 0
Italy
State/province [251] 0 0
Seriate
Country [252] 0 0
Italy
State/province [252] 0 0
Siena
Country [253] 0 0
Italy
State/province [253] 0 0
Torrette Di Ancona
Country [254] 0 0
Italy
State/province [254] 0 0
Trieste
Country [255] 0 0
Italy
State/province [255] 0 0
Vimercate MB
Country [256] 0 0
Japan
State/province [256] 0 0
Aichi
Country [257] 0 0
Japan
State/province [257] 0 0
Chiba
Country [258] 0 0
Japan
State/province [258] 0 0
Ehime
Country [259] 0 0
Japan
State/province [259] 0 0
Fukuoka
Country [260] 0 0
Japan
State/province [260] 0 0
Fukushima
Country [261] 0 0
Japan
State/province [261] 0 0
Gifu
Country [262] 0 0
Japan
State/province [262] 0 0
Gunma
Country [263] 0 0
Japan
State/province [263] 0 0
Hiroshima
Country [264] 0 0
Japan
State/province [264] 0 0
Hokkaido
Country [265] 0 0
Japan
State/province [265] 0 0
Hyogo
Country [266] 0 0
Japan
State/province [266] 0 0
Ibaraki
Country [267] 0 0
Japan
State/province [267] 0 0
Ishikawa
Country [268] 0 0
Japan
State/province [268] 0 0
Iwate
Country [269] 0 0
Japan
State/province [269] 0 0
Kagawa
Country [270] 0 0
Japan
State/province [270] 0 0
Kanagawa
Country [271] 0 0
Japan
State/province [271] 0 0
Kochi
Country [272] 0 0
Japan
State/province [272] 0 0
Kumamoto
Country [273] 0 0
Japan
State/province [273] 0 0
Miyagi
Country [274] 0 0
Japan
State/province [274] 0 0
Nagano
Country [275] 0 0
Japan
State/province [275] 0 0
Nara
Country [276] 0 0
Japan
State/province [276] 0 0
Oita
Country [277] 0 0
Japan
State/province [277] 0 0
Okayama
Country [278] 0 0
Japan
State/province [278] 0 0
Okinawa
Country [279] 0 0
Japan
State/province [279] 0 0
Osaka
Country [280] 0 0
Japan
State/province [280] 0 0
Saga
Country [281] 0 0
Japan
State/province [281] 0 0
Saitama
Country [282] 0 0
Japan
State/province [282] 0 0
Shiga
Country [283] 0 0
Japan
State/province [283] 0 0
Shizuoka
Country [284] 0 0
Japan
State/province [284] 0 0
Tokyo
Country [285] 0 0
Japan
State/province [285] 0 0
Toyama
Country [286] 0 0
Lithuania
State/province [286] 0 0
Kaunas
Country [287] 0 0
Lithuania
State/province [287] 0 0
Klaipeda
Country [288] 0 0
Lithuania
State/province [288] 0 0
Vilnius
Country [289] 0 0
Mexico
State/province [289] 0 0
Coahuila
Country [290] 0 0
Mexico
State/province [290] 0 0
Distrito Federal
Country [291] 0 0
Mexico
State/province [291] 0 0
Hidalgo
Country [292] 0 0
Mexico
State/province [292] 0 0
Jalisco
Country [293] 0 0
Mexico
State/province [293] 0 0
Nuevo León
Country [294] 0 0
Mexico
State/province [294] 0 0
Querétaro
Country [295] 0 0
Mexico
State/province [295] 0 0
San Luis Potosí
Country [296] 0 0
Mexico
State/province [296] 0 0
Sinaloa
Country [297] 0 0
Mexico
State/province [297] 0 0
Veracruz
Country [298] 0 0
Mexico
State/province [298] 0 0
Aguascalientes
Country [299] 0 0
Netherlands
State/province [299] 0 0
's Hertogenbosch
Country [300] 0 0
Netherlands
State/province [300] 0 0
Almelo
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Netherlands
State/province [301] 0 0
Arnhem
Country [302] 0 0
Netherlands
State/province [302] 0 0
Breda
Country [303] 0 0
Netherlands
State/province [303] 0 0
Capelle Aan De IJssel
Country [304] 0 0
Netherlands
State/province [304] 0 0
Den Helder
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Netherlands
State/province [305] 0 0
Deventer
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Netherlands
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Doetinchem
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Netherlands
State/province [307] 0 0
Emmen
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Netherlands
State/province [308] 0 0
Goes
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Netherlands
State/province [309] 0 0
Groningen
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Netherlands
State/province [310] 0 0
Leiderdorp
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Netherlands
State/province [311] 0 0
Nijmegen
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Netherlands
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Tiel
Country [313] 0 0
Netherlands
State/province [313] 0 0
Tilburg
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Netherlands
State/province [314] 0 0
Uden
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Netherlands
State/province [315] 0 0
Zwolle
Country [316] 0 0
New Zealand
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Christchurch
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New Zealand
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Papatoetoe, Auckland
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New Zealand
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Takapuna, Auckland
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Poland
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Bialystok
Country [320] 0 0
Poland
State/province [320] 0 0
Bytom
Country [321] 0 0
Poland
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Gdansk
Country [322] 0 0
Poland
State/province [322] 0 0
Gdynia
Country [323] 0 0
Poland
State/province [323] 0 0
Gizycko
Country [324] 0 0
Poland
State/province [324] 0 0
Kazimierza Wielka
Country [325] 0 0
Poland
State/province [325] 0 0
Kielce
Country [326] 0 0
Poland
State/province [326] 0 0
Klodzko
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Poland
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Krakow
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Poland
State/province [328] 0 0
Lodz
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Poland
State/province [329] 0 0
Lublin
Country [330] 0 0
Poland
State/province [330] 0 0
Miechow
Country [331] 0 0
Poland
State/province [331] 0 0
Olawa
Country [332] 0 0
Poland
State/province [332] 0 0
Piotrkow Trybunalski
Country [333] 0 0
Poland
State/province [333] 0 0
Poznan
Country [334] 0 0
Poland
State/province [334] 0 0
Ruda Slaska
Country [335] 0 0
Poland
State/province [335] 0 0
Skierniewice
Country [336] 0 0
Poland
State/province [336] 0 0
Stalowa Wola
Country [337] 0 0
Poland
State/province [337] 0 0
Swidnik
Country [338] 0 0
Poland
State/province [338] 0 0
Tarnow
Country [339] 0 0
Poland
State/province [339] 0 0
Torun
Country [340] 0 0
Poland
State/province [340] 0 0
Warszawa
Country [341] 0 0
Poland
State/province [341] 0 0
Wloclawek
Country [342] 0 0
Poland
State/province [342] 0 0
Wroclaw
Country [343] 0 0
Poland
State/province [343] 0 0
Zabrze
Country [344] 0 0
Portugal
State/province [344] 0 0
Aveiro
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Portugal
State/province [345] 0 0
Coimbra
Country [346] 0 0
Portugal
State/province [346] 0 0
Covilha
Country [347] 0 0
Portugal
State/province [347] 0 0
Guimaraes
Country [348] 0 0
Portugal
State/province [348] 0 0
Lisboa
Country [349] 0 0
Portugal
State/province [349] 0 0
Setubal
Country [350] 0 0
Puerto Rico
State/province [350] 0 0
San Juan
Country [351] 0 0
Romania
State/province [351] 0 0
Bucarest
Country [352] 0 0
Romania
State/province [352] 0 0
Bucharest
Country [353] 0 0
Romania
State/province [353] 0 0
Bucuresti
Country [354] 0 0
Romania
State/province [354] 0 0
Cluj-Napoca
Country [355] 0 0
Romania
State/province [355] 0 0
Craiova
Country [356] 0 0
Romania
State/province [356] 0 0
Iasi
Country [357] 0 0
Romania
State/province [357] 0 0
Oradea
Country [358] 0 0
Romania
State/province [358] 0 0
Pitesti
Country [359] 0 0
Romania
State/province [359] 0 0
Targoviste
Country [360] 0 0
Romania
State/province [360] 0 0
Targu Mures
Country [361] 0 0
Romania
State/province [361] 0 0
Timisoara
Country [362] 0 0
Russian Federation
State/province [362] 0 0
Arkhangelsk
Country [363] 0 0
Russian Federation
State/province [363] 0 0
Barnaul
Country [364] 0 0
Russian Federation
State/province [364] 0 0
Ekaterinburg
Country [365] 0 0
Russian Federation
State/province [365] 0 0
Ivanovo
Country [366] 0 0
Russian Federation
State/province [366] 0 0
Izhevsk
Country [367] 0 0
Russian Federation
State/province [367] 0 0
Kemerovo
Country [368] 0 0
Russian Federation
State/province [368] 0 0
Kirov
Country [369] 0 0
Russian Federation
State/province [369] 0 0
Korolev
Country [370] 0 0
Russian Federation
State/province [370] 0 0
Krasnodar
Country [371] 0 0
Russian Federation
State/province [371] 0 0
Lomonosov
Country [372] 0 0
Russian Federation
State/province [372] 0 0
Moscow
Country [373] 0 0
Russian Federation
State/province [373] 0 0
Nizhniy Novgorod
Country [374] 0 0
Russian Federation
State/province [374] 0 0
Nizhny Novgorod
Country [375] 0 0
Russian Federation
State/province [375] 0 0
Novosibirsk
Country [376] 0 0
Russian Federation
State/province [376] 0 0
Omsk
Country [377] 0 0
Russian Federation
State/province [377] 0 0
Saint Petersburg
Country [378] 0 0
Russian Federation
State/province [378] 0 0
Saint-Petersburg
Country [379] 0 0
Russian Federation
State/province [379] 0 0
Saratov
Country [380] 0 0
Russian Federation
State/province [380] 0 0
St. Petersburg
Country [381] 0 0
Russian Federation
State/province [381] 0 0
Tomsk
Country [382] 0 0
Russian Federation
State/province [382] 0 0
Village Novoseltsy
Country [383] 0 0
Russian Federation
State/province [383] 0 0
Vladimir
Country [384] 0 0
Russian Federation
State/province [384] 0 0
Yaroslavl
Country [385] 0 0
Slovakia
State/province [385] 0 0
Banska Bystrica
Country [386] 0 0
Slovakia
State/province [386] 0 0
Bardejov
Country [387] 0 0
Slovakia
State/province [387] 0 0
Bratislava
Country [388] 0 0
Slovakia
State/province [388] 0 0
Brezno
Country [389] 0 0
Slovakia
State/province [389] 0 0
Kosice
Country [390] 0 0
Slovakia
State/province [390] 0 0
Levice
Country [391] 0 0
Slovakia
State/province [391] 0 0
Nitra
Country [392] 0 0
Slovakia
State/province [392] 0 0
Presov
Country [393] 0 0
Slovakia
State/province [393] 0 0
Rimavska Sobota
Country [394] 0 0
Slovakia
State/province [394] 0 0
Snina
Country [395] 0 0
Slovakia
State/province [395] 0 0
Svidnik
Country [396] 0 0
Slovakia
State/province [396] 0 0
Trnava
Country [397] 0 0
South Africa
State/province [397] 0 0
Free State
Country [398] 0 0
South Africa
State/province [398] 0 0
Gauteng
Country [399] 0 0
South Africa
State/province [399] 0 0
KwaZulu-Natal
Country [400] 0 0
South Africa
State/province [400] 0 0
Western Cape
Country [401] 0 0
Spain
State/province [401] 0 0
Andalucía
Country [402] 0 0
Spain
State/province [402] 0 0
Aragón
Country [403] 0 0
Spain
State/province [403] 0 0
Asturias
Country [404] 0 0
Spain
State/province [404] 0 0
Canarias
Country [405] 0 0
Spain
State/province [405] 0 0
Cantabria
Country [406] 0 0
Spain
State/province [406] 0 0
Castilla León
Country [407] 0 0
Spain
State/province [407] 0 0
Cataluña
Country [408] 0 0
Spain
State/province [408] 0 0
Comunidad Valenciana
Country [409] 0 0
Spain
State/province [409] 0 0
Galicia
Country [410] 0 0
Spain
State/province [410] 0 0
Madrid
Country [411] 0 0
Spain
State/province [411] 0 0
Murcia
Country [412] 0 0
Sweden
State/province [412] 0 0
Falun
Country [413] 0 0
Sweden
State/province [413] 0 0
Jonkoping
Country [414] 0 0
Sweden
State/province [414] 0 0
Lidköping
Country [415] 0 0
Sweden
State/province [415] 0 0
Linkoping
Country [416] 0 0
Sweden
State/province [416] 0 0
Lund
Country [417] 0 0
Sweden
State/province [417] 0 0
Orebro
Country [418] 0 0
Sweden
State/province [418] 0 0
Skelleftea
Country [419] 0 0
Switzerland
State/province [419] 0 0
Basel
Country [420] 0 0
Switzerland
State/province [420] 0 0
Bern
Country [421] 0 0
Switzerland
State/province [421] 0 0
Fribourg
Country [422] 0 0
Switzerland
State/province [422] 0 0
Geneva 14
Country [423] 0 0
Switzerland
State/province [423] 0 0
Lausanne
Country [424] 0 0
Switzerland
State/province [424] 0 0
Lugano
Country [425] 0 0
Switzerland
State/province [425] 0 0
Zurich
Country [426] 0 0
Turkey
State/province [426] 0 0
Adana
Country [427] 0 0
Turkey
State/province [427] 0 0
Afyonkarahisar
Country [428] 0 0
Turkey
State/province [428] 0 0
Ankara
Country [429] 0 0
Turkey
State/province [429] 0 0
Corum
Country [430] 0 0
Turkey
State/province [430] 0 0
Eskisehir
Country [431] 0 0
Turkey
State/province [431] 0 0
Istanbul
Country [432] 0 0
Turkey
State/province [432] 0 0
Izmir
Country [433] 0 0
Turkey
State/province [433] 0 0
Kirikkale
Country [434] 0 0
Turkey
State/province [434] 0 0
Kocaeli
Country [435] 0 0
Turkey
State/province [435] 0 0
Konya
Country [436] 0 0
Turkey
State/province [436] 0 0
Mersin
Country [437] 0 0
Turkey
State/province [437] 0 0
Sakarya
Country [438] 0 0
Turkey
State/province [438] 0 0
Sivas
Country [439] 0 0
Turkey
State/province [439] 0 0
Van
Country [440] 0 0
Ukraine
State/province [440] 0 0
Dnipropetrovsk
Country [441] 0 0
Ukraine
State/province [441] 0 0
Ivano-Frankivsk
Country [442] 0 0
Ukraine
State/province [442] 0 0
Kharkiv
Country [443] 0 0
Ukraine
State/province [443] 0 0
Kyiv
Country [444] 0 0
Ukraine
State/province [444] 0 0
Lutsk
Country [445] 0 0
Ukraine
State/province [445] 0 0
Uzhgorod
Country [446] 0 0
Ukraine
State/province [446] 0 0
Vinnytsia
Country [447] 0 0
Ukraine
State/province [447] 0 0
Vinnytsya
Country [448] 0 0
Ukraine
State/province [448] 0 0
Zaporizhzhia
Country [449] 0 0
Ukraine
State/province [449] 0 0
Zaporizhzhya
Country [450] 0 0
United Kingdom
State/province [450] 0 0
Ayr
Country [451] 0 0
United Kingdom
State/province [451] 0 0
Basingstoke
Country [452] 0 0
United Kingdom
State/province [452] 0 0
Belfast
Country [453] 0 0
United Kingdom
State/province [453] 0 0
Blackpool
Country [454] 0 0
United Kingdom
State/province [454] 0 0
Corby
Country [455] 0 0
United Kingdom
State/province [455] 0 0
Cottingham
Country [456] 0 0
United Kingdom
State/province [456] 0 0
Dudley
Country [457] 0 0
United Kingdom
State/province [457] 0 0
Dundee
Country [458] 0 0
United Kingdom
State/province [458] 0 0
Exeter
Country [459] 0 0
United Kingdom
State/province [459] 0 0
Gillingham
Country [460] 0 0
United Kingdom
State/province [460] 0 0
Glasgow
Country [461] 0 0
United Kingdom
State/province [461] 0 0
Harlow
Country [462] 0 0
United Kingdom
State/province [462] 0 0
High Wycombe
Country [463] 0 0
United Kingdom
State/province [463] 0 0
London
Country [464] 0 0
United Kingdom
State/province [464] 0 0
Merthyr Tydfil
Country [465] 0 0
United Kingdom
State/province [465] 0 0
Newport
Country [466] 0 0
United Kingdom
State/province [466] 0 0
Northampton
Country [467] 0 0
United Kingdom
State/province [467] 0 0
Northwood
Country [468] 0 0
United Kingdom
State/province [468] 0 0
Norwich
Country [469] 0 0
United Kingdom
State/province [469] 0 0
Peterborough
Country [470] 0 0
United Kingdom
State/province [470] 0 0
Portsmouth
Country [471] 0 0
United Kingdom
State/province [471] 0 0
Romford
Country [472] 0 0
United Kingdom
State/province [472] 0 0
Sheffield
Country [473] 0 0
United Kingdom
State/province [473] 0 0
Shipley
Country [474] 0 0
United Kingdom
State/province [474] 0 0
Sidcup
Country [475] 0 0
United Kingdom
State/province [475] 0 0
Solihull
Country [476] 0 0
United Kingdom
State/province [476] 0 0
Stevenage
Country [477] 0 0
United Kingdom
State/province [477] 0 0
Sunderland
Country [478] 0 0
United Kingdom
State/province [478] 0 0
Swindon
Country [479] 0 0
United Kingdom
State/province [479] 0 0
Taunton
Country [480] 0 0
United Kingdom
State/province [480] 0 0
Torquay
Country [481] 0 0
United Kingdom
State/province [481] 0 0
Worcester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cytokinetics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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 URL below.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.amgen.com/datasharing


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02929329