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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00853658
Registration number
NCT00853658
Ethics application status
Date submitted
26/02/2009
Date registered
2/03/2009
Date last updated
25/11/2016
Titles & IDs
Public title
Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbidity-mortality in Patients With Chronic Heart Failure
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Scientific title
A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of Both Aliskiren Monotherapy and Aliskiren/Enalapril Combination Therapy Compared to Enalapril Monotherapy, on Morbidity and Mortality in Patients With Chronic Heart Failure (NYHA Class II - IV). The Study is Also Known as Aliskiren Trial of Minimizing OutcomeS in Patients With HEart Failure (ATMOSPHERE).
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Secondary ID [1]
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2008-004104-31
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Secondary ID [2]
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CSPP100F2301
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Universal Trial Number (UTN)
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Trial acronym
ATMOSPHERE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Heart Failure
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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 - Enalapril
Treatment: Drugs - Aliskiren
Experimental: Combination Aliskiren / Enalapril - Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
Experimental: Aliskiren - Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
Active comparator: Enalapril - Enalapril monotherapy -10 mg film-coated tablet and administered orally.
Treatment: Drugs: Enalapril
Enalapril 10 mg film-coated tablet and administered orally.
Treatment: Drugs: Aliskiren
Aliskiren 150 mg titrated to 300 mg film-coated tablet and administered orally.
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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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Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization
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Assessment method [1]
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Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization due to HF.
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Timepoint [1]
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up to End of Study (78 months)
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Secondary outcome [1]
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Change From Baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score
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Assessment method [1]
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Change from baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
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Timepoint [1]
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Baseline, Month 12
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Secondary outcome [2]
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All Cause Death
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Assessment method [2]
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Number of patients - All-cause death. All-cause death is common in Heart Failure HF patients this measures how many patients had this event.
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Timepoint [2]
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up to end of study (78 months)
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Eligibility
Key inclusion criteria
Inclusion Criteria
Patients eligible for inclusion in this study had to fulfill all of the following criteria:
1. Patients = 18 years of age, male or female.
2. Patients with a diagnosis of chronic heart failure (NYHA
Class II - IV):
1. LVEF = 35% at Visit 1 (local measurement, within the past 6 months assessed by echocardiography, multiple uptake gated acquisition scan (MUGA), computerized tomography(CT) scan, magnetic resonance imaging (MRI) or ventricular angiography)
2. Elevated BNP or NT-proBNP at Visit 1:
BNP = 150 pg/mL (or BNP = 100 pg/mL and unplanned hospitalization for HF within the last 12 months prior to Visit 1) (according to local measurement). OR NT-proBNP = 600 pg/mL (or NT-proBNP = 400 pg/mL and unplanned hospitalization for HF within the last 12 months prior to Visit 1) (according to local measurement).
3. Patients had to be treated with an ACEI at a stable dose enalapril 10 mg daily at least or any other ACEI, e.g. ramipril, quinapril, lisinopril, fosinopril, perindopril, trandolapril; based on equivalent doses, for at least 4 weeks prior to Visit 1
4. Patients had to be treated with a beta-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks prior to visit 1 (for patients not on target dose, according to local guidelines, or in absence of that medication, the reason should be documented).
5. Written informed consent to participate in the study and ability to comply with all requirements.
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Minimum age
18
Years
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Maximum age
No limit
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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
Exclusion Criteria
Patients with any of the following were to be excluded from participation in the study:
1. History of hypersensitivity to any of the study drugs including history or allergy to ACEIs as well as known or suspected contraindications to the study drugs or previous history of intolerance to high doses of ACEIs during up- titration process.
2. Patients treated concomitantly with both an ARB and an aldosterone antagonist in addition to study drug at Visit 1.
3. Current acute decompensated HF (defined as an acute exacerbation of a chronic heart failure status manifested by typical signs and symptoms of HF like dyspnea, fatigue etc., that may require IV therapy with diuretics, vasodilators and/or inotropic drugs).
4. Symptomatic hypotension and/or less than 95 mmHg systolic blood pressure (SBP) at Visit 1 and/or less than 90 mmHg SBP at Visit 4.
5. Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or major vascular surgery, percutaneous coronary intervention (PCI) or carotid angioplasty, within the past 3 months prior to Visit 1.
6. Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 6 months after Visit 1.
7. Right heart failure due to severe pulmonary disease.
8. Patients with Diabetes Mellitus.
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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
1/03/2009
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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
1/10/2015
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Sample size
Target
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Accrual to date
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Final
7064
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Canberra
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Novartis Investigative Site - Darlinghurst
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2605 - Canberra
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2010 - Darlinghurst
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2747 - Kingswood
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2500 - Wollongong
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4066 - Auchenflower
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4101 - Woolloongabba
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4102 - Wooloongabba
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5042 - Bedford Park
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7250 - Launceston
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3220 - Geelong
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3181 - Prahran
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Recruitment outside Australia
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0
Denmark
Query!
State/province [114]
0
0
Hillerød
Query!
Country [115]
0
0
Denmark
Query!
State/province [115]
0
0
Hjørring
Query!
Country [116]
0
0
Denmark
Query!
State/province [116]
0
0
Holbæk
Query!
Country [117]
0
0
Denmark
Query!
State/province [117]
0
0
Hvidovre
Query!
Country [118]
0
0
Denmark
Query!
State/province [118]
0
0
Køge
Query!
Country [119]
0
0
Denmark
Query!
State/province [119]
0
0
Næstved
Query!
Country [120]
0
0
Denmark
Query!
State/province [120]
0
0
Odense C
Query!
Country [121]
0
0
Denmark
Query!
State/province [121]
0
0
Randers NØ
Query!
Country [122]
0
0
Denmark
Query!
State/province [122]
0
0
Silkeborg
Query!
Country [123]
0
0
Denmark
Query!
State/province [123]
0
0
Svendborg
Query!
Country [124]
0
0
Denmark
Query!
State/province [124]
0
0
Viborg
Query!
Country [125]
0
0
Denmark
Query!
State/province [125]
0
0
Århus N
Query!
Country [126]
0
0
Dominican Republic
Query!
State/province [126]
0
0
Republica Dominicana
Query!
Country [127]
0
0
Dominican Republic
Query!
State/province [127]
0
0
San Cristobal
Query!
Country [128]
0
0
Estonia
Query!
State/province [128]
0
0
Parnu
Query!
Country [129]
0
0
Estonia
Query!
State/province [129]
0
0
Tallinn
Query!
Country [130]
0
0
Estonia
Query!
State/province [130]
0
0
Tartu
Query!
Country [131]
0
0
Finland
Query!
State/province [131]
0
0
Hyvinkää
Query!
Country [132]
0
0
Finland
Query!
State/province [132]
0
0
Jyvaskyla
Query!
Country [133]
0
0
Finland
Query!
State/province [133]
0
0
Seinajoki
Query!
Country [134]
0
0
Finland
Query!
State/province [134]
0
0
Tammisaari
Query!
Country [135]
0
0
Finland
Query!
State/province [135]
0
0
Turku
Query!
Country [136]
0
0
France
Query!
State/province [136]
0
0
Albi
Query!
Country [137]
0
0
France
Query!
State/province [137]
0
0
Angers
Query!
Country [138]
0
0
France
Query!
State/province [138]
0
0
Becon Les Granits
Query!
Country [139]
0
0
France
Query!
State/province [139]
0
0
Clichy
Query!
Country [140]
0
0
France
Query!
State/province [140]
0
0
Dijon
Query!
Country [141]
0
0
France
Query!
State/province [141]
0
0
Grenoble
Query!
Country [142]
0
0
France
Query!
State/province [142]
0
0
Marseille Cedex 05
Query!
Country [143]
0
0
France
Query!
State/province [143]
0
0
Marseille
Query!
Country [144]
0
0
France
Query!
State/province [144]
0
0
Paris
Query!
Country [145]
0
0
France
Query!
State/province [145]
0
0
Pessac Cedex
Query!
Country [146]
0
0
France
Query!
State/province [146]
0
0
Saint-Etienne
Query!
Country [147]
0
0
France
Query!
State/province [147]
0
0
Vandoeuvre Les Nancy
Query!
Country [148]
0
0
Germany
Query!
State/province [148]
0
0
Lower Saxony
Query!
Country [149]
0
0
Germany
Query!
State/province [149]
0
0
Augsburg
Query!
Country [150]
0
0
Germany
Query!
State/province [150]
0
0
Bad Nauheim
Query!
Country [151]
0
0
Germany
Query!
State/province [151]
0
0
Bad Neustadt an der Saale
Query!
Country [152]
0
0
Germany
Query!
State/province [152]
0
0
Bensheim
Query!
Country [153]
0
0
Germany
Query!
State/province [153]
0
0
Berlin
Query!
Country [154]
0
0
Germany
Query!
State/province [154]
0
0
Bochum
Query!
Country [155]
0
0
Germany
Query!
State/province [155]
0
0
Bonn
Query!
Country [156]
0
0
Germany
Query!
State/province [156]
0
0
Brake
Query!
Country [157]
0
0
Germany
Query!
State/province [157]
0
0
Celle
Query!
Country [158]
0
0
Germany
Query!
State/province [158]
0
0
Chemnitz
Query!
Country [159]
0
0
Germany
Query!
State/province [159]
0
0
Coburg
Query!
Country [160]
0
0
Germany
Query!
State/province [160]
0
0
Darmstadt
Query!
Country [161]
0
0
Germany
Query!
State/province [161]
0
0
Dessau-Roßlau
Query!
Country [162]
0
0
Germany
Query!
State/province [162]
0
0
Dinkelsbühl
Query!
Country [163]
0
0
Germany
Query!
State/province [163]
0
0
Dorsten
Query!
Country [164]
0
0
Germany
Query!
State/province [164]
0
0
Dortmund
Query!
Country [165]
0
0
Germany
Query!
State/province [165]
0
0
Dresden
Query!
Country [166]
0
0
Germany
Query!
State/province [166]
0
0
Duisburg
Query!
Country [167]
0
0
Germany
Query!
State/province [167]
0
0
Düsseldorf
Query!
Country [168]
0
0
Germany
Query!
State/province [168]
0
0
Ebersbach
Query!
Country [169]
0
0
Germany
Query!
State/province [169]
0
0
Erfurt
Query!
Country [170]
0
0
Germany
Query!
State/province [170]
0
0
Erkner
Query!
Country [171]
0
0
Germany
Query!
State/province [171]
0
0
Essen
Query!
Country [172]
0
0
Germany
Query!
State/province [172]
0
0
Frankfurt
Query!
Country [173]
0
0
Germany
Query!
State/province [173]
0
0
Goettingen
Query!
Country [174]
0
0
Germany
Query!
State/province [174]
0
0
Gotha
Query!
Country [175]
0
0
Germany
Query!
State/province [175]
0
0
Göttingen
Query!
Country [176]
0
0
Germany
Query!
State/province [176]
0
0
Gütersloh
Query!
Country [177]
0
0
Germany
Query!
State/province [177]
0
0
Halle (Saale)
Query!
Country [178]
0
0
Germany
Query!
State/province [178]
0
0
Halle/Saale
Query!
Country [179]
0
0
Germany
Query!
State/province [179]
0
0
Hamburg
Query!
Country [180]
0
0
Germany
Query!
State/province [180]
0
0
Hannover
Query!
Country [181]
0
0
Germany
Query!
State/province [181]
0
0
Hassloch
Query!
Country [182]
0
0
Germany
Query!
State/province [182]
0
0
Heidelberg
Query!
Country [183]
0
0
Germany
Query!
State/province [183]
0
0
Heilbronn
Query!
Country [184]
0
0
Germany
Query!
State/province [184]
0
0
Helmbrechts
Query!
Country [185]
0
0
Germany
Query!
State/province [185]
0
0
Heppenheim
Query!
Country [186]
0
0
Germany
Query!
State/province [186]
0
0
Kassel
Query!
Country [187]
0
0
Germany
Query!
State/province [187]
0
0
Kleve
Query!
Country [188]
0
0
Germany
Query!
State/province [188]
0
0
Koblenz
Query!
Country [189]
0
0
Germany
Query!
State/province [189]
0
0
Krefeld
Query!
Country [190]
0
0
Germany
Query!
State/province [190]
0
0
Köln
Query!
Country [191]
0
0
Germany
Query!
State/province [191]
0
0
Königsbrück
Query!
Country [192]
0
0
Germany
Query!
State/province [192]
0
0
Köthen
Query!
Country [193]
0
0
Germany
Query!
State/province [193]
0
0
Lambrecht
Query!
Country [194]
0
0
Germany
Query!
State/province [194]
0
0
Landshut
Query!
Country [195]
0
0
Germany
Query!
State/province [195]
0
0
Leipzig
Query!
Country [196]
0
0
Germany
Query!
State/province [196]
0
0
Lichtentanne
Query!
Country [197]
0
0
Germany
Query!
State/province [197]
0
0
Lienen
Query!
Country [198]
0
0
Germany
Query!
State/province [198]
0
0
Ludwigsburg
Query!
Country [199]
0
0
Germany
Query!
State/province [199]
0
0
Lörrach
Query!
Country [200]
0
0
Germany
Query!
State/province [200]
0
0
Lüneburg
Query!
Country [201]
0
0
Germany
Query!
State/province [201]
0
0
Magdeburg
Query!
Country [202]
0
0
Germany
Query!
State/province [202]
0
0
Mainz
Query!
Country [203]
0
0
Germany
Query!
State/province [203]
0
0
Markkleeberg
Query!
Country [204]
0
0
Germany
Query!
State/province [204]
0
0
Mayen
Query!
Country [205]
0
0
Germany
Query!
State/province [205]
0
0
Melsungen
Query!
Country [206]
0
0
Germany
Query!
State/province [206]
0
0
Muehldorf am Inn
Query!
Country [207]
0
0
Germany
Query!
State/province [207]
0
0
Muehlheim an der Ruhr
Query!
Country [208]
0
0
Germany
Query!
State/province [208]
0
0
Muenchen
Query!
Country [209]
0
0
Germany
Query!
State/province [209]
0
0
Mülheim
Query!
Country [210]
0
0
Germany
Query!
State/province [210]
0
0
Northeim
Query!
Country [211]
0
0
Germany
Query!
State/province [211]
0
0
Nürnberg
Query!
Country [212]
0
0
Germany
Query!
State/province [212]
0
0
Oelde
Query!
Country [213]
0
0
Germany
Query!
State/province [213]
0
0
Pirna
Query!
Country [214]
0
0
Germany
Query!
State/province [214]
0
0
Potsdam
Query!
Country [215]
0
0
Germany
Query!
State/province [215]
0
0
Reinfeld
Query!
Country [216]
0
0
Germany
Query!
State/province [216]
0
0
Salzwedel
Query!
Country [217]
0
0
Germany
Query!
State/province [217]
0
0
Schwalmstadt
Query!
Country [218]
0
0
Germany
Query!
State/province [218]
0
0
Schwäbisch Hall
Query!
Country [219]
0
0
Germany
Query!
State/province [219]
0
0
Siegen
Query!
Country [220]
0
0
Germany
Query!
State/province [220]
0
0
Solingen
Query!
Country [221]
0
0
Germany
Query!
State/province [221]
0
0
Stade
Query!
Country [222]
0
0
Germany
Query!
State/province [222]
0
0
Stuttgart
Query!
Country [223]
0
0
Germany
Query!
State/province [223]
0
0
Wedel
Query!
Country [224]
0
0
Germany
Query!
State/province [224]
0
0
Witten
Query!
Country [225]
0
0
Germany
Query!
State/province [225]
0
0
Wuerzburg
Query!
Country [226]
0
0
Germany
Query!
State/province [226]
0
0
Zwickau
Query!
Country [227]
0
0
Greece
Query!
State/province [227]
0
0
GR
Query!
Country [228]
0
0
Greece
Query!
State/province [228]
0
0
Athens
Query!
Country [229]
0
0
Greece
Query!
State/province [229]
0
0
Chios
Query!
Country [230]
0
0
Greece
Query!
State/province [230]
0
0
Edessa
Query!
Country [231]
0
0
India
Query!
State/province [231]
0
0
Andhra Pradesh
Query!
Country [232]
0
0
India
Query!
State/province [232]
0
0
Delhi
Query!
Country [233]
0
0
India
Query!
State/province [233]
0
0
Gujarat
Query!
Country [234]
0
0
India
Query!
State/province [234]
0
0
Karnataka
Query!
Country [235]
0
0
India
Query!
State/province [235]
0
0
Kerela
Query!
Country [236]
0
0
India
Query!
State/province [236]
0
0
Maharashtra
Query!
Country [237]
0
0
India
Query!
State/province [237]
0
0
New Delhi
Query!
Country [238]
0
0
India
Query!
State/province [238]
0
0
Rajasthan
Query!
Country [239]
0
0
India
Query!
State/province [239]
0
0
Tamil Nadu
Query!
Country [240]
0
0
India
Query!
State/province [240]
0
0
Telangana
Query!
Country [241]
0
0
India
Query!
State/province [241]
0
0
Uttar Pradesh
Query!
Country [242]
0
0
India
Query!
State/province [242]
0
0
Bangalore
Query!
Country [243]
0
0
India
Query!
State/province [243]
0
0
Hyderabad
Query!
Country [244]
0
0
India
Query!
State/province [244]
0
0
Lucknow
Query!
Country [245]
0
0
India
Query!
State/province [245]
0
0
Mumbai
Query!
Country [246]
0
0
India
Query!
State/province [246]
0
0
Noida
Query!
Country [247]
0
0
Ireland
Query!
State/province [247]
0
0
Co Dublin
Query!
Country [248]
0
0
Ireland
Query!
State/province [248]
0
0
Dublin 7
Query!
Country [249]
0
0
Ireland
Query!
State/province [249]
0
0
Dublin
Query!
Country [250]
0
0
Ireland
Query!
State/province [250]
0
0
Galway
Query!
Country [251]
0
0
Italy
Query!
State/province [251]
0
0
(pv)
Query!
Country [252]
0
0
Italy
Query!
State/province [252]
0
0
AN
Query!
Country [253]
0
0
Italy
Query!
State/province [253]
0
0
AR
Query!
Country [254]
0
0
Italy
Query!
State/province [254]
0
0
BG
Query!
Country [255]
0
0
Italy
Query!
State/province [255]
0
0
BO
Query!
Country [256]
0
0
Italy
Query!
State/province [256]
0
0
BS
Query!
Country [257]
0
0
Italy
Query!
State/province [257]
0
0
CH
Query!
Country [258]
0
0
Italy
Query!
State/province [258]
0
0
CS
Query!
Country [259]
0
0
Italy
Query!
State/province [259]
0
0
FC
Query!
Country [260]
0
0
Italy
Query!
State/province [260]
0
0
FE
Query!
Country [261]
0
0
Italy
Query!
State/province [261]
0
0
FG
Query!
Country [262]
0
0
Italy
Query!
State/province [262]
0
0
FI
Query!
Country [263]
0
0
Italy
Query!
State/province [263]
0
0
IS
Query!
Country [264]
0
0
Italy
Query!
State/province [264]
0
0
LE
Query!
Country [265]
0
0
Italy
Query!
State/province [265]
0
0
LI
Query!
Country [266]
0
0
Italy
Query!
State/province [266]
0
0
LU
Query!
Country [267]
0
0
Italy
Query!
State/province [267]
0
0
MI
Query!
Country [268]
0
0
Italy
Query!
State/province [268]
0
0
MN
Query!
Country [269]
0
0
Italy
Query!
State/province [269]
0
0
MS
Query!
Country [270]
0
0
Italy
Query!
State/province [270]
0
0
PA
Query!
Country [271]
0
0
Italy
Query!
State/province [271]
0
0
PG
Query!
Country [272]
0
0
Italy
Query!
State/province [272]
0
0
PR
Query!
Country [273]
0
0
Italy
Query!
State/province [273]
0
0
PV
Query!
Country [274]
0
0
Italy
Query!
State/province [274]
0
0
RA
Query!
Country [275]
0
0
Italy
Query!
State/province [275]
0
0
RM
Query!
Country [276]
0
0
Italy
Query!
State/province [276]
0
0
RN
Query!
Country [277]
0
0
Italy
Query!
State/province [277]
0
0
SA
Query!
Country [278]
0
0
Italy
Query!
State/province [278]
0
0
SI
Query!
Country [279]
0
0
Italy
Query!
State/province [279]
0
0
SO
Query!
Country [280]
0
0
Italy
Query!
State/province [280]
0
0
SP
Query!
Country [281]
0
0
Italy
Query!
State/province [281]
0
0
SS
Query!
Country [282]
0
0
Italy
Query!
State/province [282]
0
0
TO
Query!
Country [283]
0
0
Italy
Query!
State/province [283]
0
0
TR
Query!
Country [284]
0
0
Italy
Query!
State/province [284]
0
0
TS
Query!
Country [285]
0
0
Italy
Query!
State/province [285]
0
0
TV
Query!
Country [286]
0
0
Italy
Query!
State/province [286]
0
0
UD
Query!
Country [287]
0
0
Italy
Query!
State/province [287]
0
0
VA
Query!
Country [288]
0
0
Italy
Query!
State/province [288]
0
0
VR
Query!
Country [289]
0
0
Japan
Query!
State/province [289]
0
0
Aichi
Query!
Country [290]
0
0
Japan
Query!
State/province [290]
0
0
Chiba
Query!
Country [291]
0
0
Japan
Query!
State/province [291]
0
0
Fukuoka
Query!
Country [292]
0
0
Japan
Query!
State/province [292]
0
0
Gifu
Query!
Country [293]
0
0
Japan
Query!
State/province [293]
0
0
Hiroshima
Query!
Country [294]
0
0
Japan
Query!
State/province [294]
0
0
Hokkaido
Query!
Country [295]
0
0
Japan
Query!
State/province [295]
0
0
Hyogo
Query!
Country [296]
0
0
Japan
Query!
State/province [296]
0
0
Ibaraki
Query!
Country [297]
0
0
Japan
Query!
State/province [297]
0
0
Ishikawa
Query!
Country [298]
0
0
Japan
Query!
State/province [298]
0
0
Kanagawa
Query!
Country [299]
0
0
Japan
Query!
State/province [299]
0
0
Kumamoto
Query!
Country [300]
0
0
Japan
Query!
State/province [300]
0
0
Miyagi
Query!
Country [301]
0
0
Japan
Query!
State/province [301]
0
0
Nara
Query!
Country [302]
0
0
Japan
Query!
State/province [302]
0
0
Okayama
Query!
Country [303]
0
0
Japan
Query!
State/province [303]
0
0
Osaka
Query!
Country [304]
0
0
Japan
Query!
State/province [304]
0
0
Saga
Query!
Country [305]
0
0
Japan
Query!
State/province [305]
0
0
Shimane
Query!
Country [306]
0
0
Japan
Query!
State/province [306]
0
0
Tokushima
Query!
Country [307]
0
0
Japan
Query!
State/province [307]
0
0
Tokyo
Query!
Country [308]
0
0
Japan
Query!
State/province [308]
0
0
Yamaguchi
Query!
Country [309]
0
0
Japan
Query!
State/province [309]
0
0
Fukushima
Query!
Country [310]
0
0
Japan
Query!
State/province [310]
0
0
Nagasaki
Query!
Country [311]
0
0
Japan
Query!
State/province [311]
0
0
Toyama
Query!
Country [312]
0
0
Korea, Republic of
Query!
State/province [312]
0
0
Gyeonggi
Query!
Country [313]
0
0
Korea, Republic of
Query!
State/province [313]
0
0
Korea
Query!
Country [314]
0
0
Korea, Republic of
Query!
State/province [314]
0
0
Busan
Query!
Country [315]
0
0
Korea, Republic of
Query!
State/province [315]
0
0
Daejeon
Query!
Country [316]
0
0
Korea, Republic of
Query!
State/province [316]
0
0
Gwangju
Query!
Country [317]
0
0
Korea, Republic of
Query!
State/province [317]
0
0
Incheon
Query!
Country [318]
0
0
Korea, Republic of
Query!
State/province [318]
0
0
Seoul
Query!
Country [319]
0
0
Korea, Republic of
Query!
State/province [319]
0
0
Taegu
Query!
Country [320]
0
0
Latvia
Query!
State/province [320]
0
0
Daugavpils
Query!
Country [321]
0
0
Latvia
Query!
State/province [321]
0
0
Riga
Query!
Country [322]
0
0
Lithuania
Query!
State/province [322]
0
0
LTU
Query!
Country [323]
0
0
Lithuania
Query!
State/province [323]
0
0
Kaunas
Query!
Country [324]
0
0
Lithuania
Query!
State/province [324]
0
0
Klaipeda
Query!
Country [325]
0
0
Lithuania
Query!
State/province [325]
0
0
Vilnius
Query!
Country [326]
0
0
Mexico
Query!
State/province [326]
0
0
Jalisco
Query!
Country [327]
0
0
Mexico
Query!
State/province [327]
0
0
Nuevo León
Query!
Country [328]
0
0
Mexico
Query!
State/province [328]
0
0
Sinaloa
Query!
Country [329]
0
0
Mexico
Query!
State/province [329]
0
0
Aguascalientes
Query!
Country [330]
0
0
Mexico
Query!
State/province [330]
0
0
Querétaro
Query!
Country [331]
0
0
Mexico
Query!
State/province [331]
0
0
San Luis Potosi
Query!
Country [332]
0
0
Netherlands
Query!
State/province [332]
0
0
Alkmaar
Query!
Country [333]
0
0
Netherlands
Query!
State/province [333]
0
0
Amsterdam
Query!
Country [334]
0
0
Netherlands
Query!
State/province [334]
0
0
Apeldoorn
Query!
Country [335]
0
0
Netherlands
Query!
State/province [335]
0
0
Deventer
Query!
Country [336]
0
0
Netherlands
Query!
State/province [336]
0
0
Dirksland
Query!
Country [337]
0
0
Netherlands
Query!
State/province [337]
0
0
Enschede
Query!
Country [338]
0
0
Netherlands
Query!
State/province [338]
0
0
Groningen
Query!
Country [339]
0
0
Netherlands
Query!
State/province [339]
0
0
Haarlem
Query!
Country [340]
0
0
Netherlands
Query!
State/province [340]
0
0
Heerlen
Query!
Country [341]
0
0
Netherlands
Query!
State/province [341]
0
0
Leeuwarden
Query!
Country [342]
0
0
Netherlands
Query!
State/province [342]
0
0
Leiderdorp
Query!
Country [343]
0
0
Netherlands
Query!
State/province [343]
0
0
Meppel
Query!
Country [344]
0
0
Netherlands
Query!
State/province [344]
0
0
Rotterdam
Query!
Country [345]
0
0
Netherlands
Query!
State/province [345]
0
0
Venlo
Query!
Country [346]
0
0
Netherlands
Query!
State/province [346]
0
0
Wildervank
Query!
Country [347]
0
0
Netherlands
Query!
State/province [347]
0
0
Zutphen
Query!
Country [348]
0
0
Netherlands
Query!
State/province [348]
0
0
Zwolle
Query!
Country [349]
0
0
Norway
Query!
State/province [349]
0
0
Oslo
Query!
Country [350]
0
0
Norway
Query!
State/province [350]
0
0
Trondheim
Query!
Country [351]
0
0
Norway
Query!
State/province [351]
0
0
Tønsberg
Query!
Country [352]
0
0
Peru
Query!
State/province [352]
0
0
La Libertad
Query!
Country [353]
0
0
Peru
Query!
State/province [353]
0
0
Lambayeque
Query!
Country [354]
0
0
Peru
Query!
State/province [354]
0
0
Lima
Query!
Country [355]
0
0
Poland
Query!
State/province [355]
0
0
Bytom
Query!
Country [356]
0
0
Poland
Query!
State/province [356]
0
0
Chorzow
Query!
Country [357]
0
0
Poland
Query!
State/province [357]
0
0
Gdansk
Query!
Country [358]
0
0
Poland
Query!
State/province [358]
0
0
Gdynia
Query!
Country [359]
0
0
Poland
Query!
State/province [359]
0
0
Gliwice
Query!
Country [360]
0
0
Poland
Query!
State/province [360]
0
0
Grodzisk Mazowiecki
Query!
Country [361]
0
0
Poland
Query!
State/province [361]
0
0
Katowice
Query!
Country [362]
0
0
Poland
Query!
State/province [362]
0
0
Klodzko
Query!
Country [363]
0
0
Poland
Query!
State/province [363]
0
0
Krakow
Query!
Country [364]
0
0
Poland
Query!
State/province [364]
0
0
Kraków
Query!
Country [365]
0
0
Poland
Query!
State/province [365]
0
0
Lomza
Query!
Country [366]
0
0
Poland
Query!
State/province [366]
0
0
Olawa
Query!
Country [367]
0
0
Poland
Query!
State/province [367]
0
0
Opole
Query!
Country [368]
0
0
Poland
Query!
State/province [368]
0
0
Ostrow Wielkopolski
Query!
Country [369]
0
0
Poland
Query!
State/province [369]
0
0
Ostrowiec Swietokrzyski
Query!
Country [370]
0
0
Poland
Query!
State/province [370]
0
0
Piotrkow Trybunalski
Query!
Country [371]
0
0
Poland
Query!
State/province [371]
0
0
Plock
Query!
Country [372]
0
0
Poland
Query!
State/province [372]
0
0
Poznan
Query!
Country [373]
0
0
Poland
Query!
State/province [373]
0
0
Sandomierz
Query!
Country [374]
0
0
Poland
Query!
State/province [374]
0
0
Tarnow
Query!
Country [375]
0
0
Poland
Query!
State/province [375]
0
0
Torun
Query!
Country [376]
0
0
Poland
Query!
State/province [376]
0
0
Warszawa
Query!
Country [377]
0
0
Poland
Query!
State/province [377]
0
0
Wroclaw
Query!
Country [378]
0
0
Poland
Query!
State/province [378]
0
0
Zabrze
Query!
Country [379]
0
0
Portugal
Query!
State/province [379]
0
0
Amadora
Query!
Country [380]
0
0
Portugal
Query!
State/province [380]
0
0
Aveiro
Query!
Country [381]
0
0
Portugal
Query!
State/province [381]
0
0
Carnaxide
Query!
Country [382]
0
0
Portugal
Query!
State/province [382]
0
0
Coimbra
Query!
Country [383]
0
0
Portugal
Query!
State/province [383]
0
0
Faro
Query!
Country [384]
0
0
Portugal
Query!
State/province [384]
0
0
Lisboa
Query!
Country [385]
0
0
Portugal
Query!
State/province [385]
0
0
Penafiel
Query!
Country [386]
0
0
Portugal
Query!
State/province [386]
0
0
Porto
Query!
Country [387]
0
0
Puerto Rico
Query!
State/province [387]
0
0
Humacao
Query!
Country [388]
0
0
Puerto Rico
Query!
State/province [388]
0
0
Ponce
Query!
Country [389]
0
0
Puerto Rico
Query!
State/province [389]
0
0
San Juan
Query!
Country [390]
0
0
Romania
Query!
State/province [390]
0
0
District 1
Query!
Country [391]
0
0
Romania
Query!
State/province [391]
0
0
District 2
Query!
Country [392]
0
0
Romania
Query!
State/province [392]
0
0
Jud Iasi
Query!
Country [393]
0
0
Romania
Query!
State/province [393]
0
0
jud Mures
Query!
Country [394]
0
0
Romania
Query!
State/province [394]
0
0
Jud. Iasi
Query!
Country [395]
0
0
Romania
Query!
State/province [395]
0
0
Mures
Query!
Country [396]
0
0
Romania
Query!
State/province [396]
0
0
Baia Mare
Query!
Country [397]
0
0
Romania
Query!
State/province [397]
0
0
Brasov
Query!
Country [398]
0
0
Romania
Query!
State/province [398]
0
0
Cluj Napoca
Query!
Country [399]
0
0
Romania
Query!
State/province [399]
0
0
Cluj-Napoca
Query!
Country [400]
0
0
Romania
Query!
State/province [400]
0
0
Iasi
Query!
Country [401]
0
0
Romania
Query!
State/province [401]
0
0
Oradea
Query!
Country [402]
0
0
Romania
Query!
State/province [402]
0
0
Pitesti
Query!
Country [403]
0
0
Romania
Query!
State/province [403]
0
0
Targu Mures
Query!
Country [404]
0
0
Romania
Query!
State/province [404]
0
0
Timisoara
Query!
Country [405]
0
0
Russian Federation
Query!
State/province [405]
0
0
Barnaul
Query!
Country [406]
0
0
Russian Federation
Query!
State/province [406]
0
0
Chelyabinsk
Query!
Country [407]
0
0
Russian Federation
Query!
State/province [407]
0
0
Ekaterinburg
Query!
Country [408]
0
0
Russian Federation
Query!
State/province [408]
0
0
Izhevsk
Query!
Country [409]
0
0
Russian Federation
Query!
State/province [409]
0
0
Kirov
Query!
Country [410]
0
0
Russian Federation
Query!
State/province [410]
0
0
Krasnodar
Query!
Country [411]
0
0
Russian Federation
Query!
State/province [411]
0
0
Kursk
Query!
Country [412]
0
0
Russian Federation
Query!
State/province [412]
0
0
Lubertsi
Query!
Country [413]
0
0
Russian Federation
Query!
State/province [413]
0
0
Moscow
Query!
Country [414]
0
0
Russian Federation
Query!
State/province [414]
0
0
Nizhny Novgorod
Query!
Country [415]
0
0
Russian Federation
Query!
State/province [415]
0
0
Novosibirsk
Query!
Country [416]
0
0
Russian Federation
Query!
State/province [416]
0
0
Omsk
Query!
Country [417]
0
0
Russian Federation
Query!
State/province [417]
0
0
Perm
Query!
Country [418]
0
0
Russian Federation
Query!
State/province [418]
0
0
Pushkin,St-Petersburg
Query!
Country [419]
0
0
Russian Federation
Query!
State/province [419]
0
0
Ryazan
Query!
Country [420]
0
0
Russian Federation
Query!
State/province [420]
0
0
S.-Petersburg
Query!
Country [421]
0
0
Russian Federation
Query!
State/province [421]
0
0
Saint Petersburg
Query!
Country [422]
0
0
Russian Federation
Query!
State/province [422]
0
0
Saint-Petersburg
Query!
Country [423]
0
0
Russian Federation
Query!
State/province [423]
0
0
Saratov
Query!
Country [424]
0
0
Russian Federation
Query!
State/province [424]
0
0
St-Petersburg
Query!
Country [425]
0
0
Russian Federation
Query!
State/province [425]
0
0
St. Petersburg
Query!
Country [426]
0
0
Russian Federation
Query!
State/province [426]
0
0
Tyumen
Query!
Country [427]
0
0
Russian Federation
Query!
State/province [427]
0
0
Volgograd
Query!
Country [428]
0
0
Russian Federation
Query!
State/province [428]
0
0
Voronezh
Query!
Country [429]
0
0
Russian Federation
Query!
State/province [429]
0
0
Yaroslavl
Query!
Country [430]
0
0
Slovakia
Query!
State/province [430]
0
0
Slovak Republic
Query!
Country [431]
0
0
Slovakia
Query!
State/province [431]
0
0
Slovak republic
Query!
Country [432]
0
0
Slovakia
Query!
State/province [432]
0
0
Bardejov
Query!
Country [433]
0
0
Slovakia
Query!
State/province [433]
0
0
Bratislava
Query!
Country [434]
0
0
Slovakia
Query!
State/province [434]
0
0
Kosice
Query!
Country [435]
0
0
Slovakia
Query!
State/province [435]
0
0
Lucenec
Query!
Country [436]
0
0
Slovakia
Query!
State/province [436]
0
0
Piestany
Query!
Country [437]
0
0
Slovakia
Query!
State/province [437]
0
0
Presov
Query!
Country [438]
0
0
Slovakia
Query!
State/province [438]
0
0
Trebisov
Query!
Country [439]
0
0
Slovakia
Query!
State/province [439]
0
0
Trencin
Query!
Country [440]
0
0
Slovakia
Query!
State/province [440]
0
0
Zilina
Query!
Country [441]
0
0
South Africa
Query!
State/province [441]
0
0
Gauteng
Query!
Country [442]
0
0
South Africa
Query!
State/province [442]
0
0
Benoni
Query!
Country [443]
0
0
South Africa
Query!
State/province [443]
0
0
Boksburg
Query!
Country [444]
0
0
South Africa
Query!
State/province [444]
0
0
Centurion
Query!
Country [445]
0
0
South Africa
Query!
State/province [445]
0
0
Johannesburg
Query!
Country [446]
0
0
South Africa
Query!
State/province [446]
0
0
Western Cape
Query!
Country [447]
0
0
South Africa
Query!
State/province [447]
0
0
Worcester
Query!
Country [448]
0
0
Spain
Query!
State/province [448]
0
0
Andalucia
Query!
Country [449]
0
0
Spain
Query!
State/province [449]
0
0
Asturias
Query!
Country [450]
0
0
Spain
Query!
State/province [450]
0
0
Barcelona
Query!
Country [451]
0
0
Spain
Query!
State/province [451]
0
0
Cadiz
Query!
Country [452]
0
0
Spain
Query!
State/province [452]
0
0
Catalunya
Query!
Country [453]
0
0
Spain
Query!
State/province [453]
0
0
Cataluña
Query!
Country [454]
0
0
Spain
Query!
State/province [454]
0
0
Comunidad Valenciana
Query!
Country [455]
0
0
Spain
Query!
State/province [455]
0
0
Galicia
Query!
Country [456]
0
0
Spain
Query!
State/province [456]
0
0
Madrid
Query!
Country [457]
0
0
Sweden
Query!
State/province [457]
0
0
Falun
Query!
Country [458]
0
0
Sweden
Query!
State/province [458]
0
0
Göteborg
Query!
Country [459]
0
0
Sweden
Query!
State/province [459]
0
0
Karlstad
Query!
Country [460]
0
0
Sweden
Query!
State/province [460]
0
0
Linkoping
Query!
Country [461]
0
0
Sweden
Query!
State/province [461]
0
0
Lund
Query!
Country [462]
0
0
Sweden
Query!
State/province [462]
0
0
Malmo
Query!
Country [463]
0
0
Sweden
Query!
State/province [463]
0
0
Malmö
Query!
Country [464]
0
0
Sweden
Query!
State/province [464]
0
0
Mölndal
Query!
Country [465]
0
0
Sweden
Query!
State/province [465]
0
0
Nässjö
Query!
Country [466]
0
0
Sweden
Query!
State/province [466]
0
0
Skelleftea
Query!
Country [467]
0
0
Sweden
Query!
State/province [467]
0
0
Stockholm
Query!
Country [468]
0
0
Sweden
Query!
State/province [468]
0
0
Sundsvall
Query!
Country [469]
0
0
Sweden
Query!
State/province [469]
0
0
Umeå
Query!
Country [470]
0
0
Sweden
Query!
State/province [470]
0
0
Uppsala
Query!
Country [471]
0
0
Sweden
Query!
State/province [471]
0
0
Västerås
Query!
Country [472]
0
0
Sweden
Query!
State/province [472]
0
0
Örebro
Query!
Country [473]
0
0
Switzerland
Query!
State/province [473]
0
0
Basel
Query!
Country [474]
0
0
Switzerland
Query!
State/province [474]
0
0
Bellinzona
Query!
Country [475]
0
0
Switzerland
Query!
State/province [475]
0
0
Bern
Query!
Country [476]
0
0
Switzerland
Query!
State/province [476]
0
0
Biel
Query!
Country [477]
0
0
Switzerland
Query!
State/province [477]
0
0
Bruderholz
Query!
Country [478]
0
0
Switzerland
Query!
State/province [478]
0
0
Lugano
Query!
Country [479]
0
0
Switzerland
Query!
State/province [479]
0
0
Olten
Query!
Country [480]
0
0
Switzerland
Query!
State/province [480]
0
0
Winterthur
Query!
Country [481]
0
0
Switzerland
Query!
State/province [481]
0
0
Zuerich
Query!
Country [482]
0
0
Taiwan
Query!
State/province [482]
0
0
Tainan
Query!
Country [483]
0
0
Taiwan
Query!
State/province [483]
0
0
Taiwan ROC
Query!
Country [484]
0
0
Taiwan
Query!
State/province [484]
0
0
Kaohsiung
Query!
Country [485]
0
0
Taiwan
Query!
State/province [485]
0
0
Lin-Kou
Query!
Country [486]
0
0
Taiwan
Query!
State/province [486]
0
0
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Sivas
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Funding & Sponsors
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Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Summary
Brief summary
The study will evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy as compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV.
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Trial website
https://clinicaltrials.gov/study/NCT00853658
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Trial related presentations / publications
Shen L, Claggett BL, Jhund PS, Abraham WT, Desai AS, Dickstein K, Gong J, Kober LV, Lefkowitz MP, Rouleau JL, Shi VC, Swedberg K, Zile MR, Solomon SD, McMurray JJV. Development and external validation of prognostic models to predict sudden and pump-failure death in patients with HFrEF from PARADIGM-HF and ATMOSPHERE. Clin Res Cardiol. 2021 Aug;110(8):1334-1349. doi: 10.1007/s00392-021-01888-x. Epub 2021 Jun 8. Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD012569. doi: 10.1002/14651858.CD012569.pub2. Kristensen SL, Castagno D, Shen L, Jhund PS, Docherty KF, Rorth R, Abraham WT, Desai AS, Dickstein K, Rouleau JL, Zile MR, Swedberg K, Packer M, Solomon SD, Kober L, McMurray JJV; PARADIGM-HF and ATMOSPHERE Committees and Investigators.. Prevalence and incidence of intra-ventricular conduction delays and outcomes in patients with heart failure and reduced ejection fraction: insights from PARADIGM-HF and ATMOSPHERE. Eur J Heart Fail. 2020 Dec;22(12):2370-2379. doi: 10.1002/ejhf.1972. Epub 2020 Sep 14. Docherty KF, Shen L, Castagno D, Petrie MC, Abraham WT, Bohm M, Desai AS, Dickstein K, Kober LV, Packer M, Rouleau JL, Solomon SD, Swedberg K, Vazir A, Zile MR, Jhund PS, McMurray JJV. Relationship between heart rate and outcomes in patients in sinus rhythm or atrial fibrillation with heart failure and reduced ejection fraction. Eur J Heart Fail. 2020 Mar;22(3):528-538. doi: 10.1002/ejhf.1682. Epub 2019 Dec 17. Dewan P, Rorth R, Raparelli V, Campbell RT, Shen L, Jhund PS, Petrie MC, Anand IS, Carson PE, Desai AS, Granger CB, Kober L, Komajda M, McKelvie RS, O'Meara E, Pfeffer MA, Pitt B, Solomon SD, Swedberg K, Zile MR, McMurray JJV. Sex-Related Differences in Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2019 Dec;12(12):e006539. doi: 10.1161/CIRCHEARTFAILURE.119.006539. Epub 2019 Dec 9. Erratum In: Circ Heart Fail. 2020 Jan;13(1):e000036. doi: 10.1161/HHF.0000000000000036. Shen L, Ramires F, Martinez F, Bodanese LC, Echeverria LE, Gomez EA, Abraham WT, Dickstein K, Kober L, Packer M, Rouleau JL, Solomon SD, Swedberg K, Zile MR, Jhund PS, Gimpelewicz CR, McMurray JJV; PARADIGM-HF and ATMOSPHERE Investigators and Committees. Contemporary Characteristics and Outcomes in Chagasic Heart Failure Compared With Other Nonischemic and Ischemic Cardiomyopathy. Circ Heart Fail. 2017 Nov;10(11):e004361. doi: 10.1161/CIRCHEARTFAILURE.117.004361. Kristensen SL, Jhund PS, Mogensen UM, Rorth R, Abraham WT, Desai A, Dickstein K, Rouleau JL, Zile MR, Swedberg K, Packer M, Solomon SD, Kober L, McMurray JJV; PARADIGM-HF and ATMOSPHERE Committees and Investigators. Prognostic Value of N-Terminal Pro-B-Type Natriuretic Peptide Levels in Heart Failure Patients With and Without Atrial Fibrillation. Circ Heart Fail. 2017 Oct;10(10):e004409. doi: 10.1161/CIRCHEARTFAILURE.117.004409. Kristensen SL, Mogensen UM, Tarnesby G, Gimpelewicz CR, Ali MA, Shao Q, Chiang Y, Jhund PS, Abraham WT, Dickstein K, McMurray JJV, Kober L. Aliskiren alone or in combination with enalapril vs. enalapril among patients with chronic heart failure with and without diabetes: a subgroup analysis from the ATMOSPHERE trial. Eur J Heart Fail. 2018 Jan;20(1):136-147. doi: 10.1002/ejhf.896. Epub 2017 Sep 25. McMurray JJ, Krum H, Abraham WT, Dickstein K, Kober LV, Desai AS, Solomon SD, Greenlaw N, Ali MA, Chiang Y, Shao Q, Tarnesby G, Massie BM; ATMOSPHERE Committees Investigators. Aliskiren, Enalapril, or Aliskiren and Enalapril in Heart Failure. N Engl J Med. 2016 Apr 21;374(16):1521-32. doi: 10.1056/NEJMoa1514859. Epub 2016 Apr 4.
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Public notes
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Contacts
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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No information has been provided regarding IPD availability
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 are available at
https://clinicaltrials.gov/study/NCT00853658
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