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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06307652
Registration number
NCT06307652
Ethics application status
Date submitted
6/02/2024
Date registered
13/03/2024
Titles & IDs
Public title
Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function
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Scientific title
A Phase III, Randomised, Double-blind Study to Evaluate the Effect of Balcinrenone/Dapagliflozin, Compared With Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients With Heart Failure and Impaired Kidney Function
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Secondary ID [1]
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D6402C00012
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Universal Trial Number (UTN)
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Trial acronym
BalanceD-HF
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure and Impaired Kidney Function
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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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 - balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg
Treatment: Drugs - balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg
Treatment: Drugs - dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin
Experimental: balcinrenone/dapagliflozin 15 mg/10 mg - Patients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin
Experimental: balcinrenone/dapagliflozin 40 mg/10 mg - Patients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin
Active comparator: dapagliflozin 10 mg - Patients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin
Treatment: Drugs: balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg
1 capsule of balcinrenone/dapagliflozin 15 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
Treatment: Drugs: balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg
1 capsule of balcinrenone/dapagliflozin 40 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
Treatment: Drugs: dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin
1 tablet of dapagliflozin 10 mg and 1 capsule of matching placebo for balcinrenone/dapagliflozin once daily, oral use
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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 first occurrence of any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation
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Assessment method [1]
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To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of CV death and HF events with and without hospitalisation
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Timepoint [1]
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Approximately 38 months
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Secondary outcome [1]
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Total occurrences (first and recurrent) of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation
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Assessment method [1]
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To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the rate of total occurrences of CV death, and HF events with and without hospitalisation
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Timepoint [1]
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Approximately 38 months
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Secondary outcome [2]
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Total occurrences (first and recurrent) of HF hospitalisations
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Assessment method [2]
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To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the rate of total HF hospitalisations
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Timepoint [2]
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Approximately 38 months
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Secondary outcome [3]
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Time to CV death
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Assessment method [3]
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To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of CV death
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Timepoint [3]
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Approximately 38 months
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Secondary outcome [4]
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The hierarchical composite endpoint of death from any cause, total HF events, and change from baseline in KCCQ total symptom score to 24-week post-randomisation
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Assessment method [4]
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To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of death from any cause, HF events, and improving patient reported symptoms of HF
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Timepoint [4]
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Approximately 24 weeks
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Secondary outcome [5]
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Time to death from any cause
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Assessment method [5]
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To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of death from any cause
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Timepoint [5]
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Approximately 38 months
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Eligibility
Key inclusion criteria
* Age = 18 years
* Documented diagnosis of symptomatic HF (NYHA functional class II-IV)
* Having had a recent HF event within 6 months (hospitalization or urgent visit)
* Have a LVEF value from an assessment within the last 12 months
* Managed with SoC therapy for HF and renal impairment according to local guidelines
* NT-proBNP must be >300 pg/mL (>600 pg/mL if concomitant atrial fibrillation or atrial flutter)
* Not taking an MRA
* An eGFR = 20 to < 60 mL/min/1.73 m2
* Serum/plasma potassium = 3.5 mmol/L and = 5.0 mmol/L
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Minimum age
18
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Maximum age
130
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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
* Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months
* Major cardiac surgery, coronary revascularisation or valvular repair or replacement, or implantation of a Cardiac resynchronisation therapy device within 3 months prior to enrolment or planned to undergo any of these operations
* History of hypertrophic obstructive cardiomyopathy
* Complex congenital heart disease or severe uncorrected primary valvular disease
* Symptomatic bradycardia or second- or third-degree heart block without a pacemaker
* Systolic BP < 100 mmHg, or symptomatic hypotension within the past 24 hours
* Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD or exacerbation of COPD requiring invasive mechanical ventilation assistance within 12 months prior to enrolment
* Type 1 diabetes mellitus
* Kidney replacement therapy in the past 4 weeks, currently requiring kidney replacement or imminent plan to start kidney replacement therapy
* Hepatic disease, including active HBV or HCV infection, or other cause of hepatitis, and/or hepatic impairment (Child-Pugh class A-C), AST or ALT >3 × ULN; or TBL > 2 × ULN at time of screening
* Suspected or confirmed COVID-19 infection within the last 4 weeks or hospitalisation for COVID-19 within the last 12 weeks
* Treatment with strong or moderate CYP3A4 inhibitor or inducer
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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 assessing the outcomes
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
Recruiting
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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
12/04/2024
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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
11/06/2027
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Actual
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Sample size
Target
4800
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Accrual to date
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Final
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Recruitment in Australia
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Research Site - Blacktown
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2148 - Blacktown
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4870 - Cairns
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2605 - Canberra
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4032 - Chermside
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3168 - Clayton
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3199 - Frankston
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3220 - Geelong
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WA6150 - Murdoch
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0
China
Query!
State/province [111]
0
0
Xianyang
Query!
Country [112]
0
0
China
Query!
State/province [112]
0
0
Xian
Query!
Country [113]
0
0
China
Query!
State/province [113]
0
0
Xuzhou
Query!
Country [114]
0
0
China
Query!
State/province [114]
0
0
Yangzhou
Query!
Country [115]
0
0
Colombia
Query!
State/province [115]
0
0
Armenia
Query!
Country [116]
0
0
Colombia
Query!
State/province [116]
0
0
Barranquilla
Query!
Country [117]
0
0
Colombia
Query!
State/province [117]
0
0
Bogotá
Query!
Country [118]
0
0
Colombia
Query!
State/province [118]
0
0
Bucaramanga
Query!
Country [119]
0
0
Colombia
Query!
State/province [119]
0
0
Cali
Query!
Country [120]
0
0
Colombia
Query!
State/province [120]
0
0
Medellin
Query!
Country [121]
0
0
Colombia
Query!
State/province [121]
0
0
Rionegro
Query!
Country [122]
0
0
Czechia
Query!
State/province [122]
0
0
Brno
Query!
Country [123]
0
0
Czechia
Query!
State/province [123]
0
0
Broumov
Query!
Country [124]
0
0
Czechia
Query!
State/province [124]
0
0
Ceska Lipa
Query!
Country [125]
0
0
Czechia
Query!
State/province [125]
0
0
Jaromer
Query!
Country [126]
0
0
Czechia
Query!
State/province [126]
0
0
Louny
Query!
Country [127]
0
0
Czechia
Query!
State/province [127]
0
0
Plzen - Bory
Query!
Country [128]
0
0
Czechia
Query!
State/province [128]
0
0
Plzen
Query!
Country [129]
0
0
Czechia
Query!
State/province [129]
0
0
Praha 2
Query!
Country [130]
0
0
Czechia
Query!
State/province [130]
0
0
Prerov
Query!
Country [131]
0
0
Czechia
Query!
State/province [131]
0
0
Slany
Query!
Country [132]
0
0
Czechia
Query!
State/province [132]
0
0
Svitavy
Query!
Country [133]
0
0
Czechia
Query!
State/province [133]
0
0
Ustí nad Labem
Query!
Country [134]
0
0
Czechia
Query!
State/province [134]
0
0
Zlin
Query!
Country [135]
0
0
Czechia
Query!
State/province [135]
0
0
Ústí nad Labem
Query!
Country [136]
0
0
Finland
Query!
State/province [136]
0
0
Helsinki
Query!
Country [137]
0
0
Finland
Query!
State/province [137]
0
0
Jyväskylä
Query!
Country [138]
0
0
Finland
Query!
State/province [138]
0
0
Tampere
Query!
Country [139]
0
0
Finland
Query!
State/province [139]
0
0
Turku
Query!
Country [140]
0
0
France
Query!
State/province [140]
0
0
Beziers
Query!
Country [141]
0
0
France
Query!
State/province [141]
0
0
Bron
Query!
Country [142]
0
0
France
Query!
State/province [142]
0
0
Caen Cedex 9
Query!
Country [143]
0
0
France
Query!
State/province [143]
0
0
Creteil
Query!
Country [144]
0
0
France
Query!
State/province [144]
0
0
Dijon
Query!
Country [145]
0
0
France
Query!
State/province [145]
0
0
La Tronche
Query!
Country [146]
0
0
France
Query!
State/province [146]
0
0
Le Coudray
Query!
Country [147]
0
0
France
Query!
State/province [147]
0
0
Limoges
Query!
Country [148]
0
0
France
Query!
State/province [148]
0
0
Montauban
Query!
Country [149]
0
0
France
Query!
State/province [149]
0
0
Montpellier Cedex
Query!
Country [150]
0
0
France
Query!
State/province [150]
0
0
Nantes cedex 1
Query!
Country [151]
0
0
France
Query!
State/province [151]
0
0
Orleans
Query!
Country [152]
0
0
France
Query!
State/province [152]
0
0
Paris
Query!
Country [153]
0
0
France
Query!
State/province [153]
0
0
Poitiers
Query!
Country [154]
0
0
France
Query!
State/province [154]
0
0
Reims
Query!
Country [155]
0
0
France
Query!
State/province [155]
0
0
Rennes Cedex 9
Query!
Country [156]
0
0
France
Query!
State/province [156]
0
0
Rouen
Query!
Country [157]
0
0
France
Query!
State/province [157]
0
0
Strasbourg Cedex
Query!
Country [158]
0
0
France
Query!
State/province [158]
0
0
Toulon
Query!
Country [159]
0
0
France
Query!
State/province [159]
0
0
Toulouse
Query!
Country [160]
0
0
France
Query!
State/province [160]
0
0
TOURS Cedex 9
Query!
Country [161]
0
0
France
Query!
State/province [161]
0
0
Valenciennes
Query!
Country [162]
0
0
Germany
Query!
State/province [162]
0
0
Bad Nauheim
Query!
Country [163]
0
0
Germany
Query!
State/province [163]
0
0
Bechhofen
Query!
Country [164]
0
0
Germany
Query!
State/province [164]
0
0
Bernau bei Berlin
Query!
Country [165]
0
0
Germany
Query!
State/province [165]
0
0
Chemnitz
Query!
Country [166]
0
0
Germany
Query!
State/province [166]
0
0
Coburg
Query!
Country [167]
0
0
Germany
Query!
State/province [167]
0
0
Dresden
Query!
Country [168]
0
0
Germany
Query!
State/province [168]
0
0
Elsterwerda
Query!
Country [169]
0
0
Germany
Query!
State/province [169]
0
0
Frankfurt
Query!
Country [170]
0
0
Germany
Query!
State/province [170]
0
0
Freiburg
Query!
Country [171]
0
0
Germany
Query!
State/province [171]
0
0
Hagen
Query!
Country [172]
0
0
Germany
Query!
State/province [172]
0
0
Hamburg
Query!
Country [173]
0
0
Germany
Query!
State/province [173]
0
0
Heidelberg
Query!
Country [174]
0
0
Germany
Query!
State/province [174]
0
0
Kaiserslautern
Query!
Country [175]
0
0
Germany
Query!
State/province [175]
0
0
Köln
Query!
Country [176]
0
0
Germany
Query!
State/province [176]
0
0
Langen
Query!
Country [177]
0
0
Germany
Query!
State/province [177]
0
0
Leipzig
Query!
Country [178]
0
0
Germany
Query!
State/province [178]
0
0
Leverkusen
Query!
Country [179]
0
0
Germany
Query!
State/province [179]
0
0
Mainz
Query!
Country [180]
0
0
Germany
Query!
State/province [180]
0
0
Mönchengladbach
Query!
Country [181]
0
0
Germany
Query!
State/province [181]
0
0
Münster
Query!
Country [182]
0
0
Germany
Query!
State/province [182]
0
0
Papenburg
Query!
Country [183]
0
0
Germany
Query!
State/province [183]
0
0
Regensburg
Query!
Country [184]
0
0
Germany
Query!
State/province [184]
0
0
Remscheid
Query!
Country [185]
0
0
Germany
Query!
State/province [185]
0
0
Rostock
Query!
Country [186]
0
0
Germany
Query!
State/province [186]
0
0
Völklingen
Query!
Country [187]
0
0
Germany
Query!
State/province [187]
0
0
Wermsdorf
Query!
Country [188]
0
0
Germany
Query!
State/province [188]
0
0
Witten
Query!
Country [189]
0
0
Greece
Query!
State/province [189]
0
0
Athens
Query!
Country [190]
0
0
Greece
Query!
State/province [190]
0
0
Dragana
Query!
Country [191]
0
0
Greece
Query!
State/province [191]
0
0
Heraklio
Query!
Country [192]
0
0
Greece
Query!
State/province [192]
0
0
Thessaloniki
Query!
Country [193]
0
0
Hungary
Query!
State/province [193]
0
0
Budapest
Query!
Country [194]
0
0
Hungary
Query!
State/province [194]
0
0
Békéscsaba
Query!
Country [195]
0
0
Hungary
Query!
State/province [195]
0
0
Gyula
Query!
Country [196]
0
0
Hungary
Query!
State/province [196]
0
0
Hódmezovásárhely
Query!
Country [197]
0
0
Hungary
Query!
State/province [197]
0
0
Kecskemét
Query!
Country [198]
0
0
Hungary
Query!
State/province [198]
0
0
Orosháza
Query!
Country [199]
0
0
Hungary
Query!
State/province [199]
0
0
Pécs
Query!
Country [200]
0
0
Hungary
Query!
State/province [200]
0
0
Székesfehérvár
Query!
Country [201]
0
0
India
Query!
State/province [201]
0
0
Ahmedabad
Query!
Country [202]
0
0
India
Query!
State/province [202]
0
0
Ajmer
Query!
Country [203]
0
0
India
Query!
State/province [203]
0
0
Bangalore
Query!
Country [204]
0
0
India
Query!
State/province [204]
0
0
Belagavi
Query!
Country [205]
0
0
India
Query!
State/province [205]
0
0
Delhi
Query!
Country [206]
0
0
India
Query!
State/province [206]
0
0
Hyderabad
Query!
Country [207]
0
0
India
Query!
State/province [207]
0
0
Kanpur
Query!
Country [208]
0
0
India
Query!
State/province [208]
0
0
Karamsad
Query!
Country [209]
0
0
India
Query!
State/province [209]
0
0
Kolkata
Query!
Country [210]
0
0
India
Query!
State/province [210]
0
0
Manipal
Query!
Country [211]
0
0
India
Query!
State/province [211]
0
0
Mysuru
Query!
Country [212]
0
0
India
Query!
State/province [212]
0
0
Nagpur
Query!
Country [213]
0
0
India
Query!
State/province [213]
0
0
New Delhi
Query!
Country [214]
0
0
India
Query!
State/province [214]
0
0
Pune
Query!
Country [215]
0
0
India
Query!
State/province [215]
0
0
Vijayawada
Query!
Country [216]
0
0
Israel
Query!
State/province [216]
0
0
Afula
Query!
Country [217]
0
0
Israel
Query!
State/province [217]
0
0
Ashkelon
Query!
Country [218]
0
0
Israel
Query!
State/province [218]
0
0
Be'er Ya'akov
Query!
Country [219]
0
0
Israel
Query!
State/province [219]
0
0
Beer Sheva
Query!
Country [220]
0
0
Israel
Query!
State/province [220]
0
0
Haifa
Query!
Country [221]
0
0
Israel
Query!
State/province [221]
0
0
Holon
Query!
Country [222]
0
0
Israel
Query!
State/province [222]
0
0
Jerusalem
Query!
Country [223]
0
0
Israel
Query!
State/province [223]
0
0
Kfar-Saba
Query!
Country [224]
0
0
Israel
Query!
State/province [224]
0
0
Nahariya
Query!
Country [225]
0
0
Israel
Query!
State/province [225]
0
0
Petah Tikva
Query!
Country [226]
0
0
Israel
Query!
State/province [226]
0
0
Tel Aviv
Query!
Country [227]
0
0
Israel
Query!
State/province [227]
0
0
Tiberias
Query!
Country [228]
0
0
Italy
Query!
State/province [228]
0
0
Acquaviva delle Fonti
Query!
Country [229]
0
0
Italy
Query!
State/province [229]
0
0
Bari
Query!
Country [230]
0
0
Italy
Query!
State/province [230]
0
0
Bergamo
Query!
Country [231]
0
0
Italy
Query!
State/province [231]
0
0
Brescia
Query!
Country [232]
0
0
Italy
Query!
State/province [232]
0
0
Catanzaro
Query!
Country [233]
0
0
Italy
Query!
State/province [233]
0
0
Cona
Query!
Country [234]
0
0
Italy
Query!
State/province [234]
0
0
Cortona
Query!
Country [235]
0
0
Italy
Query!
State/province [235]
0
0
Firenze
Query!
Country [236]
0
0
Italy
Query!
State/province [236]
0
0
Milan
Query!
Country [237]
0
0
Italy
Query!
State/province [237]
0
0
Novara
Query!
Country [238]
0
0
Italy
Query!
State/province [238]
0
0
Pavia
Query!
Country [239]
0
0
Italy
Query!
State/province [239]
0
0
San Giovanni Rotondo
Query!
Country [240]
0
0
Japan
Query!
State/province [240]
0
0
Bunkyo-ku
Query!
Country [241]
0
0
Japan
Query!
State/province [241]
0
0
Fujisawa-shi
Query!
Country [242]
0
0
Japan
Query!
State/province [242]
0
0
Fukui-shi
Query!
Country [243]
0
0
Japan
Query!
State/province [243]
0
0
Fukuoka-Shi
Query!
Country [244]
0
0
Japan
Query!
State/province [244]
0
0
Fukuoka-shi
Query!
Country [245]
0
0
Japan
Query!
State/province [245]
0
0
Fukutsu-shi
Query!
Country [246]
0
0
Japan
Query!
State/province [246]
0
0
Hakusan-shi
Query!
Country [247]
0
0
Japan
Query!
State/province [247]
0
0
Himeji
Query!
Country [248]
0
0
Japan
Query!
State/province [248]
0
0
Iwakuni-shi
Query!
Country [249]
0
0
Japan
Query!
State/province [249]
0
0
Kanazawa-shi
Query!
Country [250]
0
0
Japan
Query!
State/province [250]
0
0
Kanonji-shi
Query!
Country [251]
0
0
Japan
Query!
State/province [251]
0
0
Kasuga-shi
Query!
Country [252]
0
0
Japan
Query!
State/province [252]
0
0
Kasugai-shi
Query!
Country [253]
0
0
Japan
Query!
State/province [253]
0
0
Kawaguchi
Query!
Country [254]
0
0
Japan
Query!
State/province [254]
0
0
Kawanishi-shi
Query!
Country [255]
0
0
Japan
Query!
State/province [255]
0
0
Kishiwada-shi
Query!
Country [256]
0
0
Japan
Query!
State/province [256]
0
0
Kitakyusyu-shi
Query!
Country [257]
0
0
Japan
Query!
State/province [257]
0
0
Kobe-shi
Query!
Country [258]
0
0
Japan
Query!
State/province [258]
0
0
Kochi-shi
Query!
Country [259]
0
0
Japan
Query!
State/province [259]
0
0
Maebashi-shi
Query!
Country [260]
0
0
Japan
Query!
State/province [260]
0
0
Matsumoto-shi
Query!
Country [261]
0
0
Japan
Query!
State/province [261]
0
0
Mito-shi
Query!
Country [262]
0
0
Japan
Query!
State/province [262]
0
0
Moriyama-shi
Query!
Country [263]
0
0
Japan
Query!
State/province [263]
0
0
Nagoya-shi
Query!
Country [264]
0
0
Japan
Query!
State/province [264]
0
0
Oita-shi
Query!
Country [265]
0
0
Japan
Query!
State/province [265]
0
0
Osaka-shi
Query!
Country [266]
0
0
Japan
Query!
State/province [266]
0
0
Sagamihara-shi
Query!
Country [267]
0
0
Japan
Query!
State/province [267]
0
0
Saitama shi
Query!
Country [268]
0
0
Japan
Query!
State/province [268]
0
0
Saitama-shi
Query!
Country [269]
0
0
Japan
Query!
State/province [269]
0
0
Sakai-shi
Query!
Country [270]
0
0
Japan
Query!
State/province [270]
0
0
Sakata City
Query!
Country [271]
0
0
Japan
Query!
State/province [271]
0
0
Sanyoonoda-shi
Query!
Country [272]
0
0
Japan
Query!
State/province [272]
0
0
Toshima-ku
Query!
Country [273]
0
0
Japan
Query!
State/province [273]
0
0
Toyota City
Query!
Country [274]
0
0
Japan
Query!
State/province [274]
0
0
Tsuchiura-shi
Query!
Country [275]
0
0
Japan
Query!
State/province [275]
0
0
Ueda-shi
Query!
Country [276]
0
0
Japan
Query!
State/province [276]
0
0
Uji-shi
Query!
Country [277]
0
0
Japan
Query!
State/province [277]
0
0
Uwajima-shi
Query!
Country [278]
0
0
Japan
Query!
State/province [278]
0
0
Yanagawa-shi
Query!
Country [279]
0
0
Japan
Query!
State/province [279]
0
0
Yokohama-shi
Query!
Country [280]
0
0
Korea, Republic of
Query!
State/province [280]
0
0
Busan
Query!
Country [281]
0
0
Korea, Republic of
Query!
State/province [281]
0
0
Gwangju
Query!
Country [282]
0
0
Korea, Republic of
Query!
State/province [282]
0
0
Incheon
Query!
Country [283]
0
0
Korea, Republic of
Query!
State/province [283]
0
0
Seongnam-si
Query!
Country [284]
0
0
Korea, Republic of
Query!
State/province [284]
0
0
Seoul
Query!
Country [285]
0
0
Korea, Republic of
Query!
State/province [285]
0
0
Wonju-si
Query!
Country [286]
0
0
Korea, Republic of
Query!
State/province [286]
0
0
Yangsan-si
Query!
Country [287]
0
0
Malaysia
Query!
State/province [287]
0
0
Kajang
Query!
Country [288]
0
0
Malaysia
Query!
State/province [288]
0
0
Kota Kinabalu
Query!
Country [289]
0
0
Malaysia
Query!
State/province [289]
0
0
Kota Samarahan
Query!
Country [290]
0
0
Malaysia
Query!
State/province [290]
0
0
Kuala Lumpur
Query!
Country [291]
0
0
Malaysia
Query!
State/province [291]
0
0
Kuala Terengganu
Query!
Country [292]
0
0
Malaysia
Query!
State/province [292]
0
0
Kuantan
Query!
Country [293]
0
0
Malaysia
Query!
State/province [293]
0
0
Sungai Buloh
Query!
Country [294]
0
0
Mexico
Query!
State/province [294]
0
0
Aguascalientes
Query!
Country [295]
0
0
Mexico
Query!
State/province [295]
0
0
Chihuahua
Query!
Country [296]
0
0
Mexico
Query!
State/province [296]
0
0
Cuauhtémoc
Query!
Country [297]
0
0
Mexico
Query!
State/province [297]
0
0
Culiacan
Query!
Country [298]
0
0
Mexico
Query!
State/province [298]
0
0
Culiacán
Query!
Country [299]
0
0
Mexico
Query!
State/province [299]
0
0
Guadalajara
Query!
Country [300]
0
0
Mexico
Query!
State/province [300]
0
0
Mazatlán
Query!
Country [301]
0
0
Mexico
Query!
State/province [301]
0
0
Metepec
Query!
Country [302]
0
0
Mexico
Query!
State/province [302]
0
0
Mexico City
Query!
Country [303]
0
0
Mexico
Query!
State/province [303]
0
0
Mexico
Query!
Country [304]
0
0
Mexico
Query!
State/province [304]
0
0
Monterey
Query!
Country [305]
0
0
Mexico
Query!
State/province [305]
0
0
Morelia
Query!
Country [306]
0
0
Mexico
Query!
State/province [306]
0
0
México
Query!
Country [307]
0
0
Mexico
Query!
State/province [307]
0
0
Querétaro
Query!
Country [308]
0
0
Mexico
Query!
State/province [308]
0
0
San Luis Potosí
Query!
Country [309]
0
0
Mexico
Query!
State/province [309]
0
0
Tijuana
Query!
Country [310]
0
0
Mexico
Query!
State/province [310]
0
0
Torreon
Query!
Country [311]
0
0
Mexico
Query!
State/province [311]
0
0
Veracruz
Query!
Country [312]
0
0
Mexico
Query!
State/province [312]
0
0
Xalapa
Query!
Country [313]
0
0
Netherlands
Query!
State/province [313]
0
0
Amsterdam
Query!
Country [314]
0
0
Netherlands
Query!
State/province [314]
0
0
Arnhem
Query!
Country [315]
0
0
Netherlands
Query!
State/province [315]
0
0
Emmen
Query!
Country [316]
0
0
Netherlands
Query!
State/province [316]
0
0
Goes
Query!
Country [317]
0
0
Netherlands
Query!
State/province [317]
0
0
Groningen
Query!
Country [318]
0
0
Netherlands
Query!
State/province [318]
0
0
Hardenberg
Query!
Country [319]
0
0
Peru
Query!
State/province [319]
0
0
Bellavista
Query!
Country [320]
0
0
Peru
Query!
State/province [320]
0
0
Lima
Query!
Country [321]
0
0
Peru
Query!
State/province [321]
0
0
Piura
Query!
Country [322]
0
0
Philippines
Query!
State/province [322]
0
0
Angeles City
Query!
Country [323]
0
0
Philippines
Query!
State/province [323]
0
0
Cebu City
Query!
Country [324]
0
0
Philippines
Query!
State/province [324]
0
0
Davao City
Query!
Country [325]
0
0
Philippines
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State/province [325]
0
0
Iloilo City
Query!
Country [326]
0
0
Philippines
Query!
State/province [326]
0
0
Las Pinas City
Query!
Country [327]
0
0
Philippines
Query!
State/province [327]
0
0
Mabalacat
Query!
Country [328]
0
0
Philippines
Query!
State/province [328]
0
0
Makati
Query!
Country [329]
0
0
Philippines
Query!
State/province [329]
0
0
Manadaluyong City
Query!
Country [330]
0
0
Philippines
Query!
State/province [330]
0
0
Manila
Query!
Country [331]
0
0
Philippines
Query!
State/province [331]
0
0
Marikina
Query!
Country [332]
0
0
Philippines
Query!
State/province [332]
0
0
Pasig City
Query!
Country [333]
0
0
Philippines
Query!
State/province [333]
0
0
Quezon City
Query!
Country [334]
0
0
Philippines
Query!
State/province [334]
0
0
Roxas City
Query!
Country [335]
0
0
Philippines
Query!
State/province [335]
0
0
Taguig City
Query!
Country [336]
0
0
Philippines
Query!
State/province [336]
0
0
West San Juan City
Query!
Country [337]
0
0
Poland
Query!
State/province [337]
0
0
Biala Podlaska
Query!
Country [338]
0
0
Poland
Query!
State/province [338]
0
0
Bielsko-Biala
Query!
Country [339]
0
0
Poland
Query!
State/province [339]
0
0
Bydgoszcz
Query!
Country [340]
0
0
Poland
Query!
State/province [340]
0
0
Chrzanów
Query!
Country [341]
0
0
Poland
Query!
State/province [341]
0
0
Gdynia
Query!
Country [342]
0
0
Poland
Query!
State/province [342]
0
0
Kazimierza Wielka
Query!
Country [343]
0
0
Poland
Query!
State/province [343]
0
0
Kraków
Query!
Country [344]
0
0
Poland
Query!
State/province [344]
0
0
Kedzierzyn-Kozle
Query!
Country [345]
0
0
Poland
Query!
State/province [345]
0
0
Lublin
Query!
Country [346]
0
0
Poland
Query!
State/province [346]
0
0
Olsztyn
Query!
Country [347]
0
0
Poland
Query!
State/province [347]
0
0
Ostrów Mazowiecka
Query!
Country [348]
0
0
Poland
Query!
State/province [348]
0
0
Piekary Slaskie
Query!
Country [349]
0
0
Poland
Query!
State/province [349]
0
0
Poznan
Query!
Country [350]
0
0
Poland
Query!
State/province [350]
0
0
Rzeszow
Query!
Country [351]
0
0
Poland
Query!
State/province [351]
0
0
Rzeszów
Query!
Country [352]
0
0
Poland
Query!
State/province [352]
0
0
Szczecin
Query!
Country [353]
0
0
Poland
Query!
State/province [353]
0
0
Tarnów
Query!
Country [354]
0
0
Poland
Query!
State/province [354]
0
0
Torun
Query!
Country [355]
0
0
Poland
Query!
State/province [355]
0
0
Tychy
Query!
Country [356]
0
0
Poland
Query!
State/province [356]
0
0
Warszawa
Query!
Country [357]
0
0
Poland
Query!
State/province [357]
0
0
Zabrze
Query!
Country [358]
0
0
Poland
Query!
State/province [358]
0
0
Lódz
Query!
Country [359]
0
0
Romania
Query!
State/province [359]
0
0
Bucharest
Query!
Country [360]
0
0
Romania
Query!
State/province [360]
0
0
Bucuresti
Query!
Country [361]
0
0
Romania
Query!
State/province [361]
0
0
Cluj-Napoca
Query!
Country [362]
0
0
Romania
Query!
State/province [362]
0
0
Iasi
Query!
Country [363]
0
0
Romania
Query!
State/province [363]
0
0
Targu Mures
Query!
Country [364]
0
0
Romania
Query!
State/province [364]
0
0
Timisoara
Query!
Country [365]
0
0
Romania
Query!
State/province [365]
0
0
Timi?oara
Query!
Country [366]
0
0
Saudi Arabia
Query!
State/province [366]
0
0
Ar Riya?
Query!
Country [367]
0
0
Saudi Arabia
Query!
State/province [367]
0
0
Dammam
Query!
Country [368]
0
0
Saudi Arabia
Query!
State/province [368]
0
0
Jeddah
Query!
Country [369]
0
0
Saudi Arabia
Query!
State/province [369]
0
0
Riyadh
Query!
Country [370]
0
0
Slovakia
Query!
State/province [370]
0
0
Banska Bystrica
Query!
Country [371]
0
0
Slovakia
Query!
State/province [371]
0
0
Bratislava
Query!
Country [372]
0
0
Slovakia
Query!
State/province [372]
0
0
Brezno
Query!
Country [373]
0
0
Slovakia
Query!
State/province [373]
0
0
Kosice
Query!
Country [374]
0
0
Slovakia
Query!
State/province [374]
0
0
Martin
Query!
Country [375]
0
0
Slovakia
Query!
State/province [375]
0
0
Myjava
Query!
Country [376]
0
0
Slovakia
Query!
State/province [376]
0
0
Nitra
Query!
Country [377]
0
0
Slovakia
Query!
State/province [377]
0
0
Nove Zamky
Query!
Country [378]
0
0
Slovakia
Query!
State/province [378]
0
0
Považská Bystrica
Query!
Country [379]
0
0
Slovakia
Query!
State/province [379]
0
0
Presov
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Country [380]
0
0
Slovakia
Query!
State/province [380]
0
0
Prešov
Query!
Country [381]
0
0
Slovakia
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State/province [381]
0
0
Rimavska Sobota
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Country [382]
0
0
Slovakia
Query!
State/province [382]
0
0
Svidník
Query!
Country [383]
0
0
South Africa
Query!
State/province [383]
0
0
Cape Town
Query!
Country [384]
0
0
South Africa
Query!
State/province [384]
0
0
Centurion
Query!
Country [385]
0
0
South Africa
Query!
State/province [385]
0
0
Durban
Query!
Country [386]
0
0
South Africa
Query!
State/province [386]
0
0
Panorama
Query!
Country [387]
0
0
South Africa
Query!
State/province [387]
0
0
Parow
Query!
Country [388]
0
0
South Africa
Query!
State/province [388]
0
0
Pretoria
Query!
Country [389]
0
0
South Africa
Query!
State/province [389]
0
0
Worcester
Query!
Country [390]
0
0
Spain
Query!
State/province [390]
0
0
A Coruña
Query!
Country [391]
0
0
Spain
Query!
State/province [391]
0
0
Barcelona
Query!
Country [392]
0
0
Spain
Query!
State/province [392]
0
0
Lugo
Query!
Country [393]
0
0
Spain
Query!
State/province [393]
0
0
Madrid
Query!
Country [394]
0
0
Spain
Query!
State/province [394]
0
0
Majadahonda
Query!
Country [395]
0
0
Spain
Query!
State/province [395]
0
0
Sevilla
Query!
Country [396]
0
0
Sweden
Query!
State/province [396]
0
0
Alingsås
Query!
Country [397]
0
0
Sweden
Query!
State/province [397]
0
0
Göteborg
Query!
Country [398]
0
0
Sweden
Query!
State/province [398]
0
0
Helsingborg
Query!
Country [399]
0
0
Sweden
Query!
State/province [399]
0
0
Jonkoping
Query!
Country [400]
0
0
Sweden
Query!
State/province [400]
0
0
Karlstad
Query!
Country [401]
0
0
Sweden
Query!
State/province [401]
0
0
Lund
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Country [402]
0
0
Sweden
Query!
State/province [402]
0
0
Molndal
Query!
Country [403]
0
0
Sweden
Query!
State/province [403]
0
0
Stockholm
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Country [404]
0
0
Sweden
Query!
State/province [404]
0
0
Uppsala
Query!
Country [405]
0
0
Sweden
Query!
State/province [405]
0
0
Vasteras
Query!
Country [406]
0
0
Taiwan
Query!
State/province [406]
0
0
Changhua
Query!
Country [407]
0
0
Taiwan
Query!
State/province [407]
0
0
Kaohsiung
Query!
Country [408]
0
0
Taiwan
Query!
State/province [408]
0
0
New Taipei City
Query!
Country [409]
0
0
Taiwan
Query!
State/province [409]
0
0
New Taipei
Query!
Country [410]
0
0
Taiwan
Query!
State/province [410]
0
0
Taichung
Query!
Country [411]
0
0
Taiwan
Query!
State/province [411]
0
0
Taipei City
Query!
Country [412]
0
0
Taiwan
Query!
State/province [412]
0
0
Taipei
Query!
Country [413]
0
0
Taiwan
Query!
State/province [413]
0
0
Taoyuan
Query!
Country [414]
0
0
Taiwan
Query!
State/province [414]
0
0
Yilan
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Country [415]
0
0
Taiwan
Query!
State/province [415]
0
0
Yung Kang City
Query!
Country [416]
0
0
Thailand
Query!
State/province [416]
0
0
Bangkok
Query!
Country [417]
0
0
Thailand
Query!
State/province [417]
0
0
Chiang Mai
Query!
Country [418]
0
0
Thailand
Query!
State/province [418]
0
0
Hat Yai
Query!
Country [419]
0
0
Thailand
Query!
State/province [419]
0
0
Khon Kaen
Query!
Country [420]
0
0
Thailand
Query!
State/province [420]
0
0
Naimuang
Query!
Country [421]
0
0
Thailand
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State/province [421]
0
0
Pathumthani
Query!
Country [422]
0
0
Turkey
Query!
State/province [422]
0
0
Adana
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Country [423]
0
0
Turkey
Query!
State/province [423]
0
0
Ankara
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Country [424]
0
0
Turkey
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State/province [424]
0
0
Antalya
Query!
Country [425]
0
0
Turkey
Query!
State/province [425]
0
0
Bursa
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Country [426]
0
0
Turkey
Query!
State/province [426]
0
0
Dinar
Query!
Country [427]
0
0
Turkey
Query!
State/province [427]
0
0
Eskisehir
Query!
Country [428]
0
0
Turkey
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State/province [428]
0
0
Istanbul
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Country [429]
0
0
Turkey
Query!
State/province [429]
0
0
Izmir
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Country [430]
0
0
Turkey
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State/province [430]
0
0
Kocaeli
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Country [431]
0
0
Turkey
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State/province [431]
0
0
Kütahya
Query!
Country [432]
0
0
Turkey
Query!
State/province [432]
0
0
Merkez
Query!
Country [433]
0
0
Turkey
Query!
State/province [433]
0
0
Mugla
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Country [434]
0
0
Turkey
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State/province [434]
0
0
Sivas
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Country [435]
0
0
United Kingdom
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State/province [435]
0
0
Airdrie
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Country [436]
0
0
United Kingdom
Query!
State/province [436]
0
0
Barnet
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Country [437]
0
0
United Kingdom
Query!
State/province [437]
0
0
Cambridge
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Country [438]
0
0
United Kingdom
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State/province [438]
0
0
Chertsey
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Country [439]
0
0
United Kingdom
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State/province [439]
0
0
Clydebank
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Country [440]
0
0
United Kingdom
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State/province [440]
0
0
Exeter
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Country [441]
0
0
United Kingdom
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State/province [441]
0
0
Harefield
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Country [442]
0
0
United Kingdom
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State/province [442]
0
0
Hastings
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Country [443]
0
0
United Kingdom
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State/province [443]
0
0
High Wycombe
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Country [444]
0
0
United Kingdom
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State/province [444]
0
0
Kent
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Country [445]
0
0
United Kingdom
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State/province [445]
0
0
King's Lynn
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Country [446]
0
0
United Kingdom
Query!
State/province [446]
0
0
Lincoln
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Country [447]
0
0
United Kingdom
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State/province [447]
0
0
London
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Country [448]
0
0
United Kingdom
Query!
State/province [448]
0
0
Middlesborough
Query!
Country [449]
0
0
United Kingdom
Query!
State/province [449]
0
0
Portsmouth
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Country [450]
0
0
United Kingdom
Query!
State/province [450]
0
0
Sheffield
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Country [451]
0
0
United Kingdom
Query!
State/province [451]
0
0
Sunderland
Query!
Country [452]
0
0
United Kingdom
Query!
State/province [452]
0
0
Wakefield
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Country [453]
0
0
Vietnam
Query!
State/province [453]
0
0
Can Tho
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Country [454]
0
0
Vietnam
Query!
State/province [454]
0
0
Da Nang
Query!
Country [455]
0
0
Vietnam
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State/province [455]
0
0
Ha Noi
Query!
Country [456]
0
0
Vietnam
Query!
State/province [456]
0
0
Hai Phong
Query!
Country [457]
0
0
Vietnam
Query!
State/province [457]
0
0
Hanoi
Query!
Country [458]
0
0
Vietnam
Query!
State/province [458]
0
0
Ho Chi Minh city
Query!
Country [459]
0
0
Vietnam
Query!
State/province [459]
0
0
Ho Chi Minh City
Query!
Country [460]
0
0
Vietnam
Query!
State/province [460]
0
0
Ho Chi Minh
Query!
Country [461]
0
0
Vietnam
Query!
State/province [461]
0
0
Hochiminh city
Query!
Country [462]
0
0
Vietnam
Query!
State/province [462]
0
0
Hochiminh
Query!
Country [463]
0
0
Vietnam
Query!
State/province [463]
0
0
Hue
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
AstraZeneca
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.
Query!
Trial website
https://clinicaltrials.gov/study/NCT06307652
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
AstraZeneca Clinical Study Information Center
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1-877-240-9479
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
Query!
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Query!
Available to whom?
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06307652