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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
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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)
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Secondary ID [1]
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2016-002299-28
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Secondary ID [2]
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20110203
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Universal Trial Number (UTN)
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Trial acronym
GALACTIC-HF
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure
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Condition category
Condition code
Cardiovascular
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0
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Coronary heart disease
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Cardiovascular
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to Cardiovascular Death or First Heart Failure Event
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Assessment method [1]
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The primary outcome was a composite of a heart-failure (HF) event or cardiovascular (CV) death, whichever occurred first, in a time-to-event analysis.
A heart-failure event was defined as an urgent clinic visit, emergency department visit, or hospitalization for subjectively and objectively worsening heart failure leading to treatment intensification beyond a change in oral diuretic therapy.
All deaths and HF events were adjudicated by an independent external clinical events committee (CEC) at the Duke Clinical Research Institute, using standardized definitions based on the recent American College of Cardiology/American Heart Association (ACC/AHA) standards for endpoint definitions in cardiovascular clinical trials.
Time to cardiovascular death or first HF event was analyzed using Kaplan-Meier (KM) methods. Since the median was not calculated, the percentage of participants with a positively adjudicated event during the study is reported.
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Timepoint [1]
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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.
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Secondary outcome [1]
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Time to Cardiovascular Death
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Assessment method [1]
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Cardiovascular death includes acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, death due to cardiovascular (CV) procedures, death due to CV hemorrhage, and death due to other CV causes.
All deaths were adjudicated by an independent external clinical-events committee at the Duke Clinical Research Institute, using standardized definitions based on the recent ACC/AHA standards for endpoint definitions in cardiovascular clinical trials.
Time to cardiovascular death was analyzed using Kaplan-Meier methods. Since the median was not calculated, the percentage of participants with a positively adjudicated event during the study is reported.
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Timepoint [1]
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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.
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Secondary outcome [2]
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Change From Baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ TSS) at Week 24
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Assessment method [2]
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The Kansas City Cardiomyopathy Questionnaire is a self-administered questionnaire with a 2-week recall period that includes 23 items that map to 7 domains: symptom frequency; symptom burden; symptom stability; physical limitations; social limitations; quality of life; and self-efficacy (the patient's understanding of how to manage their heart failure). The symptom frequency and symptom burden domains are merged into a total symptom score. Scores are represented on a 0-to-100-point scale, where lower scores represent more frequent and severe symptoms and scores of 100 indicate no symptoms.
The change from baseline in KCCQ TSS was analyzed separately for each randomization setting (inpatient and outpatient).
Least squares means are from the mixed model which includes baseline total symptom score value, region, baseline eGFR, scheduled visit, treatment group and interaction of treatment with scheduled visit as covariates.
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Timepoint [2]
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Baseline and Week 24
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Secondary outcome [3]
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Time to First Heart Failure Hospitalization
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Assessment method [3]
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A HF hospitalization is defined as an event that met all of the following criteria:
1. The participant was admitted to the hospital with a primary diagnosis of HF;
2. The length of stay in the hospital extended for at least 24 hours;
3. The participant exhibited documented new or worsening symptoms due to HF on presentation;
4. The participant had objective evidence of new or worsening HF;
5. The participant received initiation or intensification of treatment specifically for HF, including an intravenous diuretic or vasoactive agent, mechanical or surgical intervention, or mechanical fluid removal.
Events were adjudicated by an independent external CEC at the Duke Clinical Research Institute using standardized definitions based on the ACC/AHA standards for endpoint definitions in CV clinical trials.
Time to first HF hospitalization was analyzed using KM methods. Since the median was not calculated, the percentage of participants with a positively adjudicated event is reported.
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Timepoint [3]
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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.
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Secondary outcome [4]
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Time to All-cause Death
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Assessment method [4]
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All events were adjudicated by an independent external clinical-events committee at the Duke Clinical Research Institute, using standardized definitions based on the recent ACC/AHA standards for endpoint definitions in cardiovascular clinical trials.
Time to all-cause death was analyzed using Kaplan-Meier methods. Since the median was not calculated, the percentage of participants with an event are reported. Events that occurred up to the earliest of last confirmed survival status date or analysis cut-off date (07 August 2020) are included.
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Timepoint [4]
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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.
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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
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Minimum age
18
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Maximum age
85
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/01/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
14/09/2020
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Sample size
Target
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Accrual to date
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Final
8256
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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2605 - Garran
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2139 - Concord
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2010 - Darlinghurst
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2170 - Liverpool
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2305 - New Lambton Heights
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4032 - Chermside
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4029 - Herston
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4102 - Woolloongabba
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5035 - Ashford
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5042 - Bedford Park
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5063 - Fullarton
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5011 - Woodville South
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3083 - Bundoora
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3199 - Frankston
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3220 - Geelong
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3121 - Richmond
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6150 - Murdoch
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Country [94]
0
0
China
Query!
State/province [94]
0
0
Guangdong
Query!
Country [95]
0
0
China
Query!
State/province [95]
0
0
Hainan
Query!
Country [96]
0
0
China
Query!
State/province [96]
0
0
Heilongjiang
Query!
Country [97]
0
0
China
Query!
State/province [97]
0
0
Henan
Query!
Country [98]
0
0
China
Query!
State/province [98]
0
0
Hunan
Query!
Country [99]
0
0
China
Query!
State/province [99]
0
0
Inner Mongolia
Query!
Country [100]
0
0
China
Query!
State/province [100]
0
0
Jiangsu
Query!
Country [101]
0
0
China
Query!
State/province [101]
0
0
Jilin
Query!
Country [102]
0
0
China
Query!
State/province [102]
0
0
Liaoning
Query!
Country [103]
0
0
China
Query!
State/province [103]
0
0
Shaanxi
Query!
Country [104]
0
0
China
Query!
State/province [104]
0
0
Shandong
Query!
Country [105]
0
0
China
Query!
State/province [105]
0
0
Shanxi
Query!
Country [106]
0
0
China
Query!
State/province [106]
0
0
Tianjin
Query!
Country [107]
0
0
China
Query!
State/province [107]
0
0
Xinjiang
Query!
Country [108]
0
0
China
Query!
State/province [108]
0
0
Zhejiang
Query!
Country [109]
0
0
China
Query!
State/province [109]
0
0
Shanghai
Query!
Country [110]
0
0
Colombia
Query!
State/province [110]
0
0
Antioquia
Query!
Country [111]
0
0
Colombia
Query!
State/province [111]
0
0
Atlántico
Query!
Country [112]
0
0
Colombia
Query!
State/province [112]
0
0
Bolívar
Query!
Country [113]
0
0
Colombia
Query!
State/province [113]
0
0
Caldas
Query!
Country [114]
0
0
Colombia
Query!
State/province [114]
0
0
Quindío
Query!
Country [115]
0
0
Colombia
Query!
State/province [115]
0
0
Santander
Query!
Country [116]
0
0
Colombia
Query!
State/province [116]
0
0
Valle Del Cauca
Query!
Country [117]
0
0
Colombia
Query!
State/province [117]
0
0
Bogota D.C.
Query!
Country [118]
0
0
Czechia
Query!
State/province [118]
0
0
Beroun
Query!
Country [119]
0
0
Czechia
Query!
State/province [119]
0
0
Brandys nad Labem
Query!
Country [120]
0
0
Czechia
Query!
State/province [120]
0
0
Brno
Query!
Country [121]
0
0
Czechia
Query!
State/province [121]
0
0
Frydek Mistek
Query!
Country [122]
0
0
Czechia
Query!
State/province [122]
0
0
Havlickuv Brod
Query!
Country [123]
0
0
Czechia
Query!
State/province [123]
0
0
Hradec Kralove
Query!
Country [124]
0
0
Czechia
Query!
State/province [124]
0
0
Jihlava
Query!
Country [125]
0
0
Czechia
Query!
State/province [125]
0
0
Karlovy Vary
Query!
Country [126]
0
0
Czechia
Query!
State/province [126]
0
0
Kladno
Query!
Country [127]
0
0
Czechia
Query!
State/province [127]
0
0
Klatovy IV
Query!
Country [128]
0
0
Czechia
Query!
State/province [128]
0
0
Kolin III
Query!
Country [129]
0
0
Czechia
Query!
State/province [129]
0
0
Liberec
Query!
Country [130]
0
0
Czechia
Query!
State/province [130]
0
0
Louny
Query!
Country [131]
0
0
Czechia
Query!
State/province [131]
0
0
Marianske Lazne
Query!
Country [132]
0
0
Czechia
Query!
State/province [132]
0
0
Mohelnice
Query!
Country [133]
0
0
Czechia
Query!
State/province [133]
0
0
Opava
Query!
Country [134]
0
0
Czechia
Query!
State/province [134]
0
0
Ostrava
Query!
Country [135]
0
0
Czechia
Query!
State/province [135]
0
0
Policka
Query!
Country [136]
0
0
Czechia
Query!
State/province [136]
0
0
Praha 10
Query!
Country [137]
0
0
Czechia
Query!
State/province [137]
0
0
Praha 1
Query!
Country [138]
0
0
Czechia
Query!
State/province [138]
0
0
Praha 2
Query!
Country [139]
0
0
Czechia
Query!
State/province [139]
0
0
Praha 5 - Smichov
Query!
Country [140]
0
0
Czechia
Query!
State/province [140]
0
0
Pribram VIII
Query!
Country [141]
0
0
Czechia
Query!
State/province [141]
0
0
Svitavy
Query!
Country [142]
0
0
Czechia
Query!
State/province [142]
0
0
Teplice
Query!
Country [143]
0
0
Czechia
Query!
State/province [143]
0
0
Uherske Hradiste
Query!
Country [144]
0
0
Czechia
Query!
State/province [144]
0
0
Zlin
Query!
Country [145]
0
0
Czechia
Query!
State/province [145]
0
0
Znojmo
Query!
Country [146]
0
0
Denmark
Query!
State/province [146]
0
0
Aalborg
Query!
Country [147]
0
0
Denmark
Query!
State/province [147]
0
0
Aarhus N
Query!
Country [148]
0
0
Denmark
Query!
State/province [148]
0
0
Esbjerg
Query!
Country [149]
0
0
Denmark
Query!
State/province [149]
0
0
Glostrup
Query!
Country [150]
0
0
Denmark
Query!
State/province [150]
0
0
Hellerup
Query!
Country [151]
0
0
Denmark
Query!
State/province [151]
0
0
Hillerod
Query!
Country [152]
0
0
Denmark
Query!
State/province [152]
0
0
Køge
Query!
Country [153]
0
0
Denmark
Query!
State/province [153]
0
0
Odense
Query!
Country [154]
0
0
Denmark
Query!
State/province [154]
0
0
Svendborg
Query!
Country [155]
0
0
France
Query!
State/province [155]
0
0
Beziers cedex
Query!
Country [156]
0
0
France
Query!
State/province [156]
0
0
Caen Cedex 9
Query!
Country [157]
0
0
France
Query!
State/province [157]
0
0
Chambray les Tours
Query!
Country [158]
0
0
France
Query!
State/province [158]
0
0
Corbeil Essonnes
Query!
Country [159]
0
0
France
Query!
State/province [159]
0
0
Créteil Cedex
Query!
Country [160]
0
0
France
Query!
State/province [160]
0
0
Dijon
Query!
Country [161]
0
0
France
Query!
State/province [161]
0
0
Grenoble Cedex 9
Query!
Country [162]
0
0
France
Query!
State/province [162]
0
0
Le Chesnay
Query!
Country [163]
0
0
France
Query!
State/province [163]
0
0
Lille Cedex
Query!
Country [164]
0
0
France
Query!
State/province [164]
0
0
Lille
Query!
Country [165]
0
0
France
Query!
State/province [165]
0
0
Limoges Cedex
Query!
Country [166]
0
0
France
Query!
State/province [166]
0
0
Lyon Cedex 03
Query!
Country [167]
0
0
France
Query!
State/province [167]
0
0
Montauban
Query!
Country [168]
0
0
France
Query!
State/province [168]
0
0
Montpellier cedex 05
Query!
Country [169]
0
0
France
Query!
State/province [169]
0
0
Nantes Cedex 1
Query!
Country [170]
0
0
France
Query!
State/province [170]
0
0
Nantes Cedex 2
Query!
Country [171]
0
0
France
Query!
State/province [171]
0
0
Nimes cedex 9
Query!
Country [172]
0
0
France
Query!
State/province [172]
0
0
Paris Cedex 13
Query!
Country [173]
0
0
France
Query!
State/province [173]
0
0
Paris
Query!
Country [174]
0
0
France
Query!
State/province [174]
0
0
Pessac Cedex
Query!
Country [175]
0
0
France
Query!
State/province [175]
0
0
Poitiers
Query!
Country [176]
0
0
France
Query!
State/province [176]
0
0
Rennes Cedex 9
Query!
Country [177]
0
0
France
Query!
State/province [177]
0
0
Saint Denis
Query!
Country [178]
0
0
France
Query!
State/province [178]
0
0
Toulon Cedex
Query!
Country [179]
0
0
France
Query!
State/province [179]
0
0
Toulouse Cedex 9
Query!
Country [180]
0
0
France
Query!
State/province [180]
0
0
Tourcoing cedex
Query!
Country [181]
0
0
France
Query!
State/province [181]
0
0
Valenciennes
Query!
Country [182]
0
0
Germany
Query!
State/province [182]
0
0
Bad Neuheim
Query!
Country [183]
0
0
Germany
Query!
State/province [183]
0
0
Berlin
Query!
Country [184]
0
0
Germany
Query!
State/province [184]
0
0
Dortmund
Query!
Country [185]
0
0
Germany
Query!
State/province [185]
0
0
Düsseldorf
Query!
Country [186]
0
0
Germany
Query!
State/province [186]
0
0
Erfurt
Query!
Country [187]
0
0
Germany
Query!
State/province [187]
0
0
Essen
Query!
Country [188]
0
0
Germany
Query!
State/province [188]
0
0
Frankfurt am Main
Query!
Country [189]
0
0
Germany
Query!
State/province [189]
0
0
Freiburg
Query!
Country [190]
0
0
Germany
Query!
State/province [190]
0
0
Greifswald
Query!
Country [191]
0
0
Germany
Query!
State/province [191]
0
0
Göttingen
Query!
Country [192]
0
0
Germany
Query!
State/province [192]
0
0
Haßloch
Query!
Country [193]
0
0
Germany
Query!
State/province [193]
0
0
Heidelberg
Query!
Country [194]
0
0
Germany
Query!
State/province [194]
0
0
Homburg
Query!
Country [195]
0
0
Germany
Query!
State/province [195]
0
0
Köln
Query!
Country [196]
0
0
Germany
Query!
State/province [196]
0
0
Langen
Query!
Country [197]
0
0
Germany
Query!
State/province [197]
0
0
Leipzig
Query!
Country [198]
0
0
Germany
Query!
State/province [198]
0
0
Ludwigshafen
Query!
Country [199]
0
0
Germany
Query!
State/province [199]
0
0
Mainz
Query!
Country [200]
0
0
Germany
Query!
State/province [200]
0
0
Markleeberg
Query!
Country [201]
0
0
Germany
Query!
State/province [201]
0
0
Witten
Query!
Country [202]
0
0
Germany
Query!
State/province [202]
0
0
Würzburg
Query!
Country [203]
0
0
Greece
Query!
State/province [203]
0
0
Alexandroupoli
Query!
Country [204]
0
0
Greece
Query!
State/province [204]
0
0
Athens
Query!
Country [205]
0
0
Greece
Query!
State/province [205]
0
0
Chaidari, Athens
Query!
Country [206]
0
0
Greece
Query!
State/province [206]
0
0
Chalkida
Query!
Country [207]
0
0
Greece
Query!
State/province [207]
0
0
Heraklion
Query!
Country [208]
0
0
Greece
Query!
State/province [208]
0
0
Ioannina
Query!
Country [209]
0
0
Greece
Query!
State/province [209]
0
0
Larissa
Query!
Country [210]
0
0
Greece
Query!
State/province [210]
0
0
Thessaloniki
Query!
Country [211]
0
0
Hungary
Query!
State/province [211]
0
0
Balatonfured
Query!
Country [212]
0
0
Hungary
Query!
State/province [212]
0
0
Bekescsaba
Query!
Country [213]
0
0
Hungary
Query!
State/province [213]
0
0
Berettyoujfalu
Query!
Country [214]
0
0
Hungary
Query!
State/province [214]
0
0
Budapest
Query!
Country [215]
0
0
Hungary
Query!
State/province [215]
0
0
Cegled
Query!
Country [216]
0
0
Hungary
Query!
State/province [216]
0
0
Dunaujvaros
Query!
Country [217]
0
0
Hungary
Query!
State/province [217]
0
0
Gyongyos
Query!
Country [218]
0
0
Hungary
Query!
State/province [218]
0
0
Gyula
Query!
Country [219]
0
0
Hungary
Query!
State/province [219]
0
0
Kaposvar
Query!
Country [220]
0
0
Hungary
Query!
State/province [220]
0
0
Komarom
Query!
Country [221]
0
0
Hungary
Query!
State/province [221]
0
0
Nyiregyhaza
Query!
Country [222]
0
0
Hungary
Query!
State/province [222]
0
0
Pecs
Query!
Country [223]
0
0
Hungary
Query!
State/province [223]
0
0
Sopron
Query!
Country [224]
0
0
Hungary
Query!
State/province [224]
0
0
Szeged
Query!
Country [225]
0
0
Hungary
Query!
State/province [225]
0
0
Szekszard
Query!
Country [226]
0
0
Hungary
Query!
State/province [226]
0
0
Szentes
Query!
Country [227]
0
0
Hungary
Query!
State/province [227]
0
0
Szolnok
Query!
Country [228]
0
0
Hungary
Query!
State/province [228]
0
0
Zalaegerszeg
Query!
Country [229]
0
0
Italy
Query!
State/province [229]
0
0
Ariccia
Query!
Country [230]
0
0
Italy
Query!
State/province [230]
0
0
Arzignano
Query!
Country [231]
0
0
Italy
Query!
State/province [231]
0
0
Bergamo
Query!
Country [232]
0
0
Italy
Query!
State/province [232]
0
0
Bologna
Query!
Country [233]
0
0
Italy
Query!
State/province [233]
0
0
Brescia
Query!
Country [234]
0
0
Italy
Query!
State/province [234]
0
0
Cagliari
Query!
Country [235]
0
0
Italy
Query!
State/province [235]
0
0
Catania
Query!
Country [236]
0
0
Italy
Query!
State/province [236]
0
0
Catanzaro
Query!
Country [237]
0
0
Italy
Query!
State/province [237]
0
0
Cona FE
Query!
Country [238]
0
0
Italy
Query!
State/province [238]
0
0
Cuneo
Query!
Country [239]
0
0
Italy
Query!
State/province [239]
0
0
Foggia
Query!
Country [240]
0
0
Italy
Query!
State/province [240]
0
0
Milano
Query!
Country [241]
0
0
Italy
Query!
State/province [241]
0
0
Monza (MB)
Query!
Country [242]
0
0
Italy
Query!
State/province [242]
0
0
Monza
Query!
Country [243]
0
0
Italy
Query!
State/province [243]
0
0
Napoli
Query!
Country [244]
0
0
Italy
Query!
State/province [244]
0
0
Palermo
Query!
Country [245]
0
0
Italy
Query!
State/province [245]
0
0
Pavia
Query!
Country [246]
0
0
Italy
Query!
State/province [246]
0
0
Perugia
Query!
Country [247]
0
0
Italy
Query!
State/province [247]
0
0
Piacenza
Query!
Country [248]
0
0
Italy
Query!
State/province [248]
0
0
Rimini
Query!
Country [249]
0
0
Italy
Query!
State/province [249]
0
0
Roma
Query!
Country [250]
0
0
Italy
Query!
State/province [250]
0
0
Rozzano MI
Query!
Country [251]
0
0
Italy
Query!
State/province [251]
0
0
Seriate
Query!
Country [252]
0
0
Italy
Query!
State/province [252]
0
0
Siena
Query!
Country [253]
0
0
Italy
Query!
State/province [253]
0
0
Torrette Di Ancona
Query!
Country [254]
0
0
Italy
Query!
State/province [254]
0
0
Trieste
Query!
Country [255]
0
0
Italy
Query!
State/province [255]
0
0
Vimercate MB
Query!
Country [256]
0
0
Japan
Query!
State/province [256]
0
0
Aichi
Query!
Country [257]
0
0
Japan
Query!
State/province [257]
0
0
Chiba
Query!
Country [258]
0
0
Japan
Query!
State/province [258]
0
0
Ehime
Query!
Country [259]
0
0
Japan
Query!
State/province [259]
0
0
Fukuoka
Query!
Country [260]
0
0
Japan
Query!
State/province [260]
0
0
Fukushima
Query!
Country [261]
0
0
Japan
Query!
State/province [261]
0
0
Gifu
Query!
Country [262]
0
0
Japan
Query!
State/province [262]
0
0
Gunma
Query!
Country [263]
0
0
Japan
Query!
State/province [263]
0
0
Hiroshima
Query!
Country [264]
0
0
Japan
Query!
State/province [264]
0
0
Hokkaido
Query!
Country [265]
0
0
Japan
Query!
State/province [265]
0
0
Hyogo
Query!
Country [266]
0
0
Japan
Query!
State/province [266]
0
0
Ibaraki
Query!
Country [267]
0
0
Japan
Query!
State/province [267]
0
0
Ishikawa
Query!
Country [268]
0
0
Japan
Query!
State/province [268]
0
0
Iwate
Query!
Country [269]
0
0
Japan
Query!
State/province [269]
0
0
Kagawa
Query!
Country [270]
0
0
Japan
Query!
State/province [270]
0
0
Kanagawa
Query!
Country [271]
0
0
Japan
Query!
State/province [271]
0
0
Kochi
Query!
Country [272]
0
0
Japan
Query!
State/province [272]
0
0
Kumamoto
Query!
Country [273]
0
0
Japan
Query!
State/province [273]
0
0
Miyagi
Query!
Country [274]
0
0
Japan
Query!
State/province [274]
0
0
Nagano
Query!
Country [275]
0
0
Japan
Query!
State/province [275]
0
0
Nara
Query!
Country [276]
0
0
Japan
Query!
State/province [276]
0
0
Oita
Query!
Country [277]
0
0
Japan
Query!
State/province [277]
0
0
Okayama
Query!
Country [278]
0
0
Japan
Query!
State/province [278]
0
0
Okinawa
Query!
Country [279]
0
0
Japan
Query!
State/province [279]
0
0
Osaka
Query!
Country [280]
0
0
Japan
Query!
State/province [280]
0
0
Saga
Query!
Country [281]
0
0
Japan
Query!
State/province [281]
0
0
Saitama
Query!
Country [282]
0
0
Japan
Query!
State/province [282]
0
0
Shiga
Query!
Country [283]
0
0
Japan
Query!
State/province [283]
0
0
Shizuoka
Query!
Country [284]
0
0
Japan
Query!
State/province [284]
0
0
Tokyo
Query!
Country [285]
0
0
Japan
Query!
State/province [285]
0
0
Toyama
Query!
Country [286]
0
0
Lithuania
Query!
State/province [286]
0
0
Kaunas
Query!
Country [287]
0
0
Lithuania
Query!
State/province [287]
0
0
Klaipeda
Query!
Country [288]
0
0
Lithuania
Query!
State/province [288]
0
0
Vilnius
Query!
Country [289]
0
0
Mexico
Query!
State/province [289]
0
0
Coahuila
Query!
Country [290]
0
0
Mexico
Query!
State/province [290]
0
0
Distrito Federal
Query!
Country [291]
0
0
Mexico
Query!
State/province [291]
0
0
Hidalgo
Query!
Country [292]
0
0
Mexico
Query!
State/province [292]
0
0
Jalisco
Query!
Country [293]
0
0
Mexico
Query!
State/province [293]
0
0
Nuevo León
Query!
Country [294]
0
0
Mexico
Query!
State/province [294]
0
0
Querétaro
Query!
Country [295]
0
0
Mexico
Query!
State/province [295]
0
0
San Luis Potosí
Query!
Country [296]
0
0
Mexico
Query!
State/province [296]
0
0
Sinaloa
Query!
Country [297]
0
0
Mexico
Query!
State/province [297]
0
0
Veracruz
Query!
Country [298]
0
0
Mexico
Query!
State/province [298]
0
0
Aguascalientes
Query!
Country [299]
0
0
Netherlands
Query!
State/province [299]
0
0
's Hertogenbosch
Query!
Country [300]
0
0
Netherlands
Query!
State/province [300]
0
0
Almelo
Query!
Country [301]
0
0
Netherlands
Query!
State/province [301]
0
0
Arnhem
Query!
Country [302]
0
0
Netherlands
Query!
State/province [302]
0
0
Breda
Query!
Country [303]
0
0
Netherlands
Query!
State/province [303]
0
0
Capelle Aan De IJssel
Query!
Country [304]
0
0
Netherlands
Query!
State/province [304]
0
0
Den Helder
Query!
Country [305]
0
0
Netherlands
Query!
State/province [305]
0
0
Deventer
Query!
Country [306]
0
0
Netherlands
Query!
State/province [306]
0
0
Doetinchem
Query!
Country [307]
0
0
Netherlands
Query!
State/province [307]
0
0
Emmen
Query!
Country [308]
0
0
Netherlands
Query!
State/province [308]
0
0
Goes
Query!
Country [309]
0
0
Netherlands
Query!
State/province [309]
0
0
Groningen
Query!
Country [310]
0
0
Netherlands
Query!
State/province [310]
0
0
Leiderdorp
Query!
Country [311]
0
0
Netherlands
Query!
State/province [311]
0
0
Nijmegen
Query!
Country [312]
0
0
Netherlands
Query!
State/province [312]
0
0
Tiel
Query!
Country [313]
0
0
Netherlands
Query!
State/province [313]
0
0
Tilburg
Query!
Country [314]
0
0
Netherlands
Query!
State/province [314]
0
0
Uden
Query!
Country [315]
0
0
Netherlands
Query!
State/province [315]
0
0
Zwolle
Query!
Country [316]
0
0
New Zealand
Query!
State/province [316]
0
0
Christchurch
Query!
Country [317]
0
0
New Zealand
Query!
State/province [317]
0
0
Papatoetoe, Auckland
Query!
Country [318]
0
0
New Zealand
Query!
State/province [318]
0
0
Takapuna, Auckland
Query!
Country [319]
0
0
Poland
Query!
State/province [319]
0
0
Bialystok
Query!
Country [320]
0
0
Poland
Query!
State/province [320]
0
0
Bytom
Query!
Country [321]
0
0
Poland
Query!
State/province [321]
0
0
Gdansk
Query!
Country [322]
0
0
Poland
Query!
State/province [322]
0
0
Gdynia
Query!
Country [323]
0
0
Poland
Query!
State/province [323]
0
0
Gizycko
Query!
Country [324]
0
0
Poland
Query!
State/province [324]
0
0
Kazimierza Wielka
Query!
Country [325]
0
0
Poland
Query!
State/province [325]
0
0
Kielce
Query!
Country [326]
0
0
Poland
Query!
State/province [326]
0
0
Klodzko
Query!
Country [327]
0
0
Poland
Query!
State/province [327]
0
0
Krakow
Query!
Country [328]
0
0
Poland
Query!
State/province [328]
0
0
Lodz
Query!
Country [329]
0
0
Poland
Query!
State/province [329]
0
0
Lublin
Query!
Country [330]
0
0
Poland
Query!
State/province [330]
0
0
Miechow
Query!
Country [331]
0
0
Poland
Query!
State/province [331]
0
0
Olawa
Query!
Country [332]
0
0
Poland
Query!
State/province [332]
0
0
Piotrkow Trybunalski
Query!
Country [333]
0
0
Poland
Query!
State/province [333]
0
0
Poznan
Query!
Country [334]
0
0
Poland
Query!
State/province [334]
0
0
Ruda Slaska
Query!
Country [335]
0
0
Poland
Query!
State/province [335]
0
0
Skierniewice
Query!
Country [336]
0
0
Poland
Query!
State/province [336]
0
0
Stalowa Wola
Query!
Country [337]
0
0
Poland
Query!
State/province [337]
0
0
Swidnik
Query!
Country [338]
0
0
Poland
Query!
State/province [338]
0
0
Tarnow
Query!
Country [339]
0
0
Poland
Query!
State/province [339]
0
0
Torun
Query!
Country [340]
0
0
Poland
Query!
State/province [340]
0
0
Warszawa
Query!
Country [341]
0
0
Poland
Query!
State/province [341]
0
0
Wloclawek
Query!
Country [342]
0
0
Poland
Query!
State/province [342]
0
0
Wroclaw
Query!
Country [343]
0
0
Poland
Query!
State/province [343]
0
0
Zabrze
Query!
Country [344]
0
0
Portugal
Query!
State/province [344]
0
0
Aveiro
Query!
Country [345]
0
0
Portugal
Query!
State/province [345]
0
0
Coimbra
Query!
Country [346]
0
0
Portugal
Query!
State/province [346]
0
0
Covilha
Query!
Country [347]
0
0
Portugal
Query!
State/province [347]
0
0
Guimaraes
Query!
Country [348]
0
0
Portugal
Query!
State/province [348]
0
0
Lisboa
Query!
Country [349]
0
0
Portugal
Query!
State/province [349]
0
0
Setubal
Query!
Country [350]
0
0
Puerto Rico
Query!
State/province [350]
0
0
San Juan
Query!
Country [351]
0
0
Romania
Query!
State/province [351]
0
0
Bucarest
Query!
Country [352]
0
0
Romania
Query!
State/province [352]
0
0
Bucharest
Query!
Country [353]
0
0
Romania
Query!
State/province [353]
0
0
Bucuresti
Query!
Country [354]
0
0
Romania
Query!
State/province [354]
0
0
Cluj-Napoca
Query!
Country [355]
0
0
Romania
Query!
State/province [355]
0
0
Craiova
Query!
Country [356]
0
0
Romania
Query!
State/province [356]
0
0
Iasi
Query!
Country [357]
0
0
Romania
Query!
State/province [357]
0
0
Oradea
Query!
Country [358]
0
0
Romania
Query!
State/province [358]
0
0
Pitesti
Query!
Country [359]
0
0
Romania
Query!
State/province [359]
0
0
Targoviste
Query!
Country [360]
0
0
Romania
Query!
State/province [360]
0
0
Targu Mures
Query!
Country [361]
0
0
Romania
Query!
State/province [361]
0
0
Timisoara
Query!
Country [362]
0
0
Russian Federation
Query!
State/province [362]
0
0
Arkhangelsk
Query!
Country [363]
0
0
Russian Federation
Query!
State/province [363]
0
0
Barnaul
Query!
Country [364]
0
0
Russian Federation
Query!
State/province [364]
0
0
Ekaterinburg
Query!
Country [365]
0
0
Russian Federation
Query!
State/province [365]
0
0
Ivanovo
Query!
Country [366]
0
0
Russian Federation
Query!
State/province [366]
0
0
Izhevsk
Query!
Country [367]
0
0
Russian Federation
Query!
State/province [367]
0
0
Kemerovo
Query!
Country [368]
0
0
Russian Federation
Query!
State/province [368]
0
0
Kirov
Query!
Country [369]
0
0
Russian Federation
Query!
State/province [369]
0
0
Korolev
Query!
Country [370]
0
0
Russian Federation
Query!
State/province [370]
0
0
Krasnodar
Query!
Country [371]
0
0
Russian Federation
Query!
State/province [371]
0
0
Lomonosov
Query!
Country [372]
0
0
Russian Federation
Query!
State/province [372]
0
0
Moscow
Query!
Country [373]
0
0
Russian Federation
Query!
State/province [373]
0
0
Nizhniy Novgorod
Query!
Country [374]
0
0
Russian Federation
Query!
State/province [374]
0
0
Nizhny Novgorod
Query!
Country [375]
0
0
Russian Federation
Query!
State/province [375]
0
0
Novosibirsk
Query!
Country [376]
0
0
Russian Federation
Query!
State/province [376]
0
0
Omsk
Query!
Country [377]
0
0
Russian Federation
Query!
State/province [377]
0
0
Saint Petersburg
Query!
Country [378]
0
0
Russian Federation
Query!
State/province [378]
0
0
Saint-Petersburg
Query!
Country [379]
0
0
Russian Federation
Query!
State/province [379]
0
0
Saratov
Query!
Country [380]
0
0
Russian Federation
Query!
State/province [380]
0
0
St. Petersburg
Query!
Country [381]
0
0
Russian Federation
Query!
State/province [381]
0
0
Tomsk
Query!
Country [382]
0
0
Russian Federation
Query!
State/province [382]
0
0
Village Novoseltsy
Query!
Country [383]
0
0
Russian Federation
Query!
State/province [383]
0
0
Vladimir
Query!
Country [384]
0
0
Russian Federation
Query!
State/province [384]
0
0
Yaroslavl
Query!
Country [385]
0
0
Slovakia
Query!
State/province [385]
0
0
Banska Bystrica
Query!
Country [386]
0
0
Slovakia
Query!
State/province [386]
0
0
Bardejov
Query!
Country [387]
0
0
Slovakia
Query!
State/province [387]
0
0
Bratislava
Query!
Country [388]
0
0
Slovakia
Query!
State/province [388]
0
0
Brezno
Query!
Country [389]
0
0
Slovakia
Query!
State/province [389]
0
0
Kosice
Query!
Country [390]
0
0
Slovakia
Query!
State/province [390]
0
0
Levice
Query!
Country [391]
0
0
Slovakia
Query!
State/province [391]
0
0
Nitra
Query!
Country [392]
0
0
Slovakia
Query!
State/province [392]
0
0
Presov
Query!
Country [393]
0
0
Slovakia
Query!
State/province [393]
0
0
Rimavska Sobota
Query!
Country [394]
0
0
Slovakia
Query!
State/province [394]
0
0
Snina
Query!
Country [395]
0
0
Slovakia
Query!
State/province [395]
0
0
Svidnik
Query!
Country [396]
0
0
Slovakia
Query!
State/province [396]
0
0
Trnava
Query!
Country [397]
0
0
South Africa
Query!
State/province [397]
0
0
Free State
Query!
Country [398]
0
0
South Africa
Query!
State/province [398]
0
0
Gauteng
Query!
Country [399]
0
0
South Africa
Query!
State/province [399]
0
0
KwaZulu-Natal
Query!
Country [400]
0
0
South Africa
Query!
State/province [400]
0
0
Western Cape
Query!
Country [401]
0
0
Spain
Query!
State/province [401]
0
0
Andalucía
Query!
Country [402]
0
0
Spain
Query!
State/province [402]
0
0
Aragón
Query!
Country [403]
0
0
Spain
Query!
State/province [403]
0
0
Asturias
Query!
Country [404]
0
0
Spain
Query!
State/province [404]
0
0
Canarias
Query!
Country [405]
0
0
Spain
Query!
State/province [405]
0
0
Cantabria
Query!
Country [406]
0
0
Spain
Query!
State/province [406]
0
0
Castilla León
Query!
Country [407]
0
0
Spain
Query!
State/province [407]
0
0
Cataluña
Query!
Country [408]
0
0
Spain
Query!
State/province [408]
0
0
Comunidad Valenciana
Query!
Country [409]
0
0
Spain
Query!
State/province [409]
0
0
Galicia
Query!
Country [410]
0
0
Spain
Query!
State/province [410]
0
0
Madrid
Query!
Country [411]
0
0
Spain
Query!
State/province [411]
0
0
Murcia
Query!
Country [412]
0
0
Sweden
Query!
State/province [412]
0
0
Falun
Query!
Country [413]
0
0
Sweden
Query!
State/province [413]
0
0
Jonkoping
Query!
Country [414]
0
0
Sweden
Query!
State/province [414]
0
0
Lidköping
Query!
Country [415]
0
0
Sweden
Query!
State/province [415]
0
0
Linkoping
Query!
Country [416]
0
0
Sweden
Query!
State/province [416]
0
0
Lund
Query!
Country [417]
0
0
Sweden
Query!
State/province [417]
0
0
Orebro
Query!
Country [418]
0
0
Sweden
Query!
State/province [418]
0
0
Skelleftea
Query!
Country [419]
0
0
Switzerland
Query!
State/province [419]
0
0
Basel
Query!
Country [420]
0
0
Switzerland
Query!
State/province [420]
0
0
Bern
Query!
Country [421]
0
0
Switzerland
Query!
State/province [421]
0
0
Fribourg
Query!
Country [422]
0
0
Switzerland
Query!
State/province [422]
0
0
Geneva 14
Query!
Country [423]
0
0
Switzerland
Query!
State/province [423]
0
0
Lausanne
Query!
Country [424]
0
0
Switzerland
Query!
State/province [424]
0
0
Lugano
Query!
Country [425]
0
0
Switzerland
Query!
State/province [425]
0
0
Zurich
Query!
Country [426]
0
0
Turkey
Query!
State/province [426]
0
0
Adana
Query!
Country [427]
0
0
Turkey
Query!
State/province [427]
0
0
Afyonkarahisar
Query!
Country [428]
0
0
Turkey
Query!
State/province [428]
0
0
Ankara
Query!
Country [429]
0
0
Turkey
Query!
State/province [429]
0
0
Corum
Query!
Country [430]
0
0
Turkey
Query!
State/province [430]
0
0
Eskisehir
Query!
Country [431]
0
0
Turkey
Query!
State/province [431]
0
0
Istanbul
Query!
Country [432]
0
0
Turkey
Query!
State/province [432]
0
0
Izmir
Query!
Country [433]
0
0
Turkey
Query!
State/province [433]
0
0
Kirikkale
Query!
Country [434]
0
0
Turkey
Query!
State/province [434]
0
0
Kocaeli
Query!
Country [435]
0
0
Turkey
Query!
State/province [435]
0
0
Konya
Query!
Country [436]
0
0
Turkey
Query!
State/province [436]
0
0
Mersin
Query!
Country [437]
0
0
Turkey
Query!
State/province [437]
0
0
Sakarya
Query!
Country [438]
0
0
Turkey
Query!
State/province [438]
0
0
Sivas
Query!
Country [439]
0
0
Turkey
Query!
State/province [439]
0
0
Van
Query!
Country [440]
0
0
Ukraine
Query!
State/province [440]
0
0
Dnipropetrovsk
Query!
Country [441]
0
0
Ukraine
Query!
State/province [441]
0
0
Ivano-Frankivsk
Query!
Country [442]
0
0
Ukraine
Query!
State/province [442]
0
0
Kharkiv
Query!
Country [443]
0
0
Ukraine
Query!
State/province [443]
0
0
Kyiv
Query!
Country [444]
0
0
Ukraine
Query!
State/province [444]
0
0
Lutsk
Query!
Country [445]
0
0
Ukraine
Query!
State/province [445]
0
0
Uzhgorod
Query!
Country [446]
0
0
Ukraine
Query!
State/province [446]
0
0
Vinnytsia
Query!
Country [447]
0
0
Ukraine
Query!
State/province [447]
0
0
Vinnytsya
Query!
Country [448]
0
0
Ukraine
Query!
State/province [448]
0
0
Zaporizhzhia
Query!
Country [449]
0
0
Ukraine
Query!
State/province [449]
0
0
Zaporizhzhya
Query!
Country [450]
0
0
United Kingdom
Query!
State/province [450]
0
0
Ayr
Query!
Country [451]
0
0
United Kingdom
Query!
State/province [451]
0
0
Basingstoke
Query!
Country [452]
0
0
United Kingdom
Query!
State/province [452]
0
0
Belfast
Query!
Country [453]
0
0
United Kingdom
Query!
State/province [453]
0
0
Blackpool
Query!
Country [454]
0
0
United Kingdom
Query!
State/province [454]
0
0
Corby
Query!
Country [455]
0
0
United Kingdom
Query!
State/province [455]
0
0
Cottingham
Query!
Country [456]
0
0
United Kingdom
Query!
State/province [456]
0
0
Dudley
Query!
Country [457]
0
0
United Kingdom
Query!
State/province [457]
0
0
Dundee
Query!
Country [458]
0
0
United Kingdom
Query!
State/province [458]
0
0
Exeter
Query!
Country [459]
0
0
United Kingdom
Query!
State/province [459]
0
0
Gillingham
Query!
Country [460]
0
0
United Kingdom
Query!
State/province [460]
0
0
Glasgow
Query!
Country [461]
0
0
United Kingdom
Query!
State/province [461]
0
0
Harlow
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Country [462]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Cytokinetics
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Ethics approval
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Summary
Brief summary
The purpose of this study is to determine if treatment with omecamtiv mecarbil 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 adults with chronic heart failure with reduced ejection fraction (HFrEF).
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Trial website
https://clinicaltrials.gov/study/NCT02929329
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Trial related presentations / publications
Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Biering-Sorensen T, Bohm M, Bonderman D, Fang JC, Lanfear DE, Lund M, Momomura SI, O'Meara E, Ponikowski P, Spinar J, Flores-Arredondo JH, Claggett BL, Heitner SB, Kupfer S, Abbasi SA, Malik FI; GALACTIC-HF Investigators. Effect of Ejection Fraction on Clinical Outcomes in Patients Treated With Omecamtiv Mecarbil in GALACTIC-HF. J Am Coll Cardiol. 2021 Jul 13;78(2):97-108. doi: 10.1016/j.jacc.2021.04.065. Epub 2021 May 17. Solomon SD, Claggett BL, Miao ZM, Diaz R, Felker GM, McMurray JJV, Metra M, Corbalan R, Filippatos G, Goudev AR, Mareev V, Serpytis P, Suter T, Yilmaz MB, Zannad F, Kupfer S, Heitner SB, Malik FI, Teerlink JR. Influence of atrial fibrillation on efficacy and safety of omecamtiv mecarbil in heart failure: the GALACTIC-HF trial. Eur Heart J. 2022 Jun 14;43(23):2212-2220. doi: 10.1093/eurheartj/ehac144. Erratum In: Eur Heart J. 2022 Aug 7;43(30):2903. doi: 10.1093/eurheartj/ehac332. Felker GM, Solomon SD, Claggett B, Diaz R, McMurray JJV, Metra M, Anand I, Crespo-Leiro MG, Dahlstrom U, Goncalvesova E, Howlett JG, MacDonald P, Parkhomenko A, Tomcsanyi J, Abbasi SA, Heitner SB, Hucko T, Kupfer S, Malik FI, Teerlink JR. Assessment of Omecamtiv Mecarbil for the Treatment of Patients With Severe Heart Failure: A Post Hoc Analysis of Data From the GALACTIC-HF Randomized Clinical Trial. JAMA Cardiol. 2022 Jan 1;7(1):26-34. doi: 10.1001/jamacardio.2021.4027. Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Adams KF, Anand I, Arias-Mendoza A, Biering-Sorensen T, Bohm M, Bonderman D, Cleland JGF, Corbalan R, Crespo-Leiro MG, Dahlstrom U, Echeverria LE, Fang JC, Filippatos G, Fonseca C, Goncalvesova E, Goudev AR, Howlett JG, Lanfear DE, Li J, Lund M, Macdonald P, Mareev V, Momomura SI, O'Meara E, Parkhomenko A, Ponikowski P, Ramires FJA, Serpytis P, Sliwa K, Spinar J, Suter TM, Tomcsanyi J, Vandekerckhove H, Vinereanu D, Voors AA, Yilmaz MB, Zannad F, Sharpsten L, Legg JC, Varin C, Honarpour N, Abbasi SA, Malik FI, Kurtz CE; GALACTIC-HF Investigators. Cardiac Myosin Activation with Omecamtiv Mecarbil in Systolic Heart Failure. N Engl J Med. 2021 Jan 14;384(2):105-116. doi: 10.1056/NEJMoa2025797. Epub 2020 Nov 13. Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Legg JC, Buchele G, Varin C, Kurtz CE, Malik FI, Honarpour N. Omecamtiv Mecarbil in Chronic Heart Failure With Reduced Ejection Fraction: Rationale and Design of GALACTIC-HF. JACC Heart Fail. 2020 Apr;8(4):329-340. doi: 10.1016/j.jchf.2019.12.001. Epub 2020 Feb 6.
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Public notes
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Contacts
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Amgen
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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)
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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.
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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.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.amgen.com/datasharing
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/29/NCT02929329/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/29/NCT02929329/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02929329