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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02104817
Registration number
NCT02104817
Ethics application status
Date submitted
2/04/2014
Date registered
4/04/2014
Titles & IDs
Public title
Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia
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Scientific title
A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh Cardiovascular Risk PatienTs With Hypertriglyceridemia (STRENGTH)
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Secondary ID [1]
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2014-001069-28
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Secondary ID [2]
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D5881C00004
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Universal Trial Number (UTN)
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Trial acronym
STRENGTH
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Metabolic and Endocrine
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0
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Epanova® (omega-3 carboxylic acids)
Treatment: Drugs - corn oil control
Experimental: EPANOVA - Epanova + statin, once daily
Active comparator: Corn oil - Corn oil + Statin
Treatment: Drugs: Epanova® (omega-3 carboxylic acids)
Adjunct to statin therapy and diet in high risk adult patients for the prevention and reduction of major adverse cardiovascular events (MACE)
Treatment: Drugs: corn oil control
corn oil control arm
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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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The Composite of Major Adverse Cardiovascular Events (MACE)
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Assessment method [1]
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MACE components include: cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
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Timepoint [1]
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From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
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Secondary outcome [1]
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The Composite of MACE in the Subgroup of Participants With Established CV Disease(CVD) at Baseline
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Assessment method [1]
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MACE components include: cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
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Timepoint [1]
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From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
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Secondary outcome [2]
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The Composite of CV Events
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Assessment method [2]
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CV events include: cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
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Timepoint [2]
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From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
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Secondary outcome [3]
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The Composite of CV Events in the Subgroup of Participants With Established CV Disease (CVD) at Baseline
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Assessment method [3]
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CV events include: cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
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Timepoint [3]
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From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
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Secondary outcome [4]
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The Composite of Coronary Events
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Assessment method [4]
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Coronary events include: cardiac death (including death due to acute myocardial infarction, sudden cardiac death and death due to cardiovascular procedures), non-fatal myocardial infarction (MI), emergent/elective coronary revascularization and hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
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Timepoint [4]
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From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
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Secondary outcome [5]
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The Composite of Coronary Events in the Subgroup of Participants With Established CVD at Baseline
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Assessment method [5]
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Coronary events include: cardiac death (including death due to acute myocardial infarction, sudden cardiac death and death due to cardiovascular procedures), non-fatal myocardial infarction (MI), emergent/elective coronary revascularization and hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed) in the subgroup of participants with established CVD at baseline
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Timepoint [5]
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From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
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Secondary outcome [6]
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CV Death
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Assessment method [6]
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Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed), last date known to be alive, and date of non-cardiovascular death.
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Timepoint [6]
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0
From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
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Secondary outcome [7]
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CV Death in the Subgroup of Participants With Established CVD at Baseline
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Assessment method [7]
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Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed), last date known to be alive, and date of non-cardiovascular death in the subgroup of participants with established CVD at baseline
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Timepoint [7]
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From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
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Secondary outcome [8]
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All-cause Death
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Assessment method [8]
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Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed) and last date known to be alive.
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Timepoint [8]
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From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
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Secondary outcome [9]
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All-cause Death in the Subgroup of Participants With Established CVD at Baseline
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Assessment method [9]
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Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed) and last date known to be alive in the subgroup of participants with established CVD at baseline
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Timepoint [9]
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From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
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Eligibility
Key inclusion criteria
1. Men or women, =18 years of age.
2. Patient must be on a stable diet and statin* therapy at least 4 weeks prior to randomization (Visit 2) and meet the following criteria:
1. LDL-C <100 mg/dL
2. TG level =180 and <500 mg/dL and HDL-C <42 mg/dL for men or HDL-C <47 mg/dL for women
3. Patient is at high risk for a future cardiovascular event if at least one of the following criteria (3a, 3b or 3c)* is present via patient history, physical exam, or medical records at the time of screening:
1. Any atherosclerotic CVD as defined in protocol.
2. History of diabetes mellitus (type 1 or 2) and =40 years of age for men and =50 years of age for women, plus one of the risk factors defined in protocol.
3. Male patients >50 years of age or females >60 years of age, with at least one of the risk factors defined in protocol.
Key
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Minimum age
18
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Maximum age
99
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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
1. Allergy or intolerance to omega-3 carboxylic acids, omega-3 fatty acids, omega-3-acid ethyl esters, or corn oil. 2.Use of fibrates, bile acid sequestrants, or niacin or its analogues (>250 mg/day) within 4 weeks prior to Visit 2. 3.Statin naïve at Visit 1.
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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 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
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
30/10/2014
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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
27/05/2020
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Sample size
Target
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Accrual to date
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Final
13078
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Adelaide
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Research Site - Blacktown
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Research Site - Box Hill
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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2148 - Blacktown
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Recruitment postcode(s) [3]
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3128 - Box Hill
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Recruitment postcode(s) [4]
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2794 - Cowra
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Recruitment postcode(s) [5]
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2871 - Forbes
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Recruitment postcode(s) [6]
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6160 - Fremantle
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Recruitment postcode(s) [7]
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4029 - Herston
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6027 - Joondalup
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Recruitment postcode(s) [9]
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2035 - Maroubra
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Recruitment postcode(s) [10]
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4064 - Milton
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4101 - South Brisbane
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Recruitment postcode(s) [12]
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4215 - Southport
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Recruitment postcode(s) [13]
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2261 - Tumbi Umbi
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Recruitment postcode(s) [14]
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2500 - Wollongong
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Recruitment outside Australia
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Alabama
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0
0
Praha 10 - Strasnice
Query!
Country [93]
0
0
Czechia
Query!
State/province [93]
0
0
Praha 5
Query!
Country [94]
0
0
Czechia
Query!
State/province [94]
0
0
Praha 8
Query!
Country [95]
0
0
Czechia
Query!
State/province [95]
0
0
Praha
Query!
Country [96]
0
0
Czechia
Query!
State/province [96]
0
0
Prerov
Query!
Country [97]
0
0
Czechia
Query!
State/province [97]
0
0
Slany
Query!
Country [98]
0
0
Czechia
Query!
State/province [98]
0
0
Tremosna
Query!
Country [99]
0
0
Czechia
Query!
State/province [99]
0
0
Trutnov
Query!
Country [100]
0
0
Czechia
Query!
State/province [100]
0
0
Zlin
Query!
Country [101]
0
0
Denmark
Query!
State/province [101]
0
0
Hellerup
Query!
Country [102]
0
0
Denmark
Query!
State/province [102]
0
0
Herlev
Query!
Country [103]
0
0
Denmark
Query!
State/province [103]
0
0
København Ø
Query!
Country [104]
0
0
Denmark
Query!
State/province [104]
0
0
Svendborg
Query!
Country [105]
0
0
Denmark
Query!
State/province [105]
0
0
Viborg
Query!
Country [106]
0
0
Denmark
Query!
State/province [106]
0
0
Ålborg
Query!
Country [107]
0
0
Denmark
Query!
State/province [107]
0
0
Århus N
Query!
Country [108]
0
0
Estonia
Query!
State/province [108]
0
0
Haabneeme
Query!
Country [109]
0
0
Estonia
Query!
State/province [109]
0
0
Pärnu
Query!
Country [110]
0
0
Estonia
Query!
State/province [110]
0
0
Tallinn
Query!
Country [111]
0
0
Estonia
Query!
State/province [111]
0
0
Tartu
Query!
Country [112]
0
0
Hungary
Query!
State/province [112]
0
0
Baja
Query!
Country [113]
0
0
Hungary
Query!
State/province [113]
0
0
Balatonfured
Query!
Country [114]
0
0
Hungary
Query!
State/province [114]
0
0
Balatongyorok
Query!
Country [115]
0
0
Hungary
Query!
State/province [115]
0
0
Ballasagyarmat
Query!
Country [116]
0
0
Hungary
Query!
State/province [116]
0
0
Budapest
Query!
Country [117]
0
0
Hungary
Query!
State/province [117]
0
0
Békéscsaba
Query!
Country [118]
0
0
Hungary
Query!
State/province [118]
0
0
Csorna
Query!
Country [119]
0
0
Hungary
Query!
State/province [119]
0
0
Debrecen
Query!
Country [120]
0
0
Hungary
Query!
State/province [120]
0
0
Eger
Query!
Country [121]
0
0
Hungary
Query!
State/province [121]
0
0
Godollo
Query!
Country [122]
0
0
Hungary
Query!
State/province [122]
0
0
Gyula
Query!
Country [123]
0
0
Hungary
Query!
State/province [123]
0
0
Gödöllo
Query!
Country [124]
0
0
Hungary
Query!
State/province [124]
0
0
Hajdúszoboszló
Query!
Country [125]
0
0
Hungary
Query!
State/province [125]
0
0
Hatvan
Query!
Country [126]
0
0
Hungary
Query!
State/province [126]
0
0
Kalocsa
Query!
Country [127]
0
0
Hungary
Query!
State/province [127]
0
0
Kiskunhalas
Query!
Country [128]
0
0
Hungary
Query!
State/province [128]
0
0
Komarom
Query!
Country [129]
0
0
Hungary
Query!
State/province [129]
0
0
Létavértes
Query!
Country [130]
0
0
Hungary
Query!
State/province [130]
0
0
Mohacs
Query!
Country [131]
0
0
Hungary
Query!
State/province [131]
0
0
Nagykanizsa
Query!
Country [132]
0
0
Hungary
Query!
State/province [132]
0
0
Nyiregyhaza
Query!
Country [133]
0
0
Hungary
Query!
State/province [133]
0
0
Nyíregyháza
Query!
Country [134]
0
0
Hungary
Query!
State/province [134]
0
0
Szeged
Query!
Country [135]
0
0
Hungary
Query!
State/province [135]
0
0
Szekszárd
Query!
Country [136]
0
0
Hungary
Query!
State/province [136]
0
0
Szentes
Query!
Country [137]
0
0
Hungary
Query!
State/province [137]
0
0
Székesfehérvár
Query!
Country [138]
0
0
Hungary
Query!
State/province [138]
0
0
Veszprem
Query!
Country [139]
0
0
Hungary
Query!
State/province [139]
0
0
Zalaegerszeg
Query!
Country [140]
0
0
Italy
Query!
State/province [140]
0
0
Bergamo
Query!
Country [141]
0
0
Italy
Query!
State/province [141]
0
0
Bologna
Query!
Country [142]
0
0
Italy
Query!
State/province [142]
0
0
Brescia
Query!
Country [143]
0
0
Italy
Query!
State/province [143]
0
0
Cinisello Balsamo
Query!
Country [144]
0
0
Italy
Query!
State/province [144]
0
0
Cona
Query!
Country [145]
0
0
Italy
Query!
State/province [145]
0
0
L'Aquila
Query!
Country [146]
0
0
Italy
Query!
State/province [146]
0
0
Milano
Query!
Country [147]
0
0
Italy
Query!
State/province [147]
0
0
Napoli
Query!
Country [148]
0
0
Italy
Query!
State/province [148]
0
0
Parma
Query!
Country [149]
0
0
Italy
Query!
State/province [149]
0
0
Pavia
Query!
Country [150]
0
0
Italy
Query!
State/province [150]
0
0
Perugia
Query!
Country [151]
0
0
Italy
Query!
State/province [151]
0
0
Roma
Query!
Country [152]
0
0
Italy
Query!
State/province [152]
0
0
San Giovanni Rotondo
Query!
Country [153]
0
0
Italy
Query!
State/province [153]
0
0
Trieste
Query!
Country [154]
0
0
Japan
Query!
State/province [154]
0
0
Adachi-ku
Query!
Country [155]
0
0
Japan
Query!
State/province [155]
0
0
Akishima-shi
Query!
Country [156]
0
0
Japan
Query!
State/province [156]
0
0
Akita-shi
Query!
Country [157]
0
0
Japan
Query!
State/province [157]
0
0
Amagasaki-shi
Query!
Country [158]
0
0
Japan
Query!
State/province [158]
0
0
Chikushi-gun
Query!
Country [159]
0
0
Japan
Query!
State/province [159]
0
0
Chikushino-shi
Query!
Country [160]
0
0
Japan
Query!
State/province [160]
0
0
Chuo-ku
Query!
Country [161]
0
0
Japan
Query!
State/province [161]
0
0
Fujisawa-shi
Query!
Country [162]
0
0
Japan
Query!
State/province [162]
0
0
Gifu-shi
Query!
Country [163]
0
0
Japan
Query!
State/province [163]
0
0
Hachioji-shi
Query!
Country [164]
0
0
Japan
Query!
State/province [164]
0
0
Hakusan-shi
Query!
Country [165]
0
0
Japan
Query!
State/province [165]
0
0
Ichikawa-shi
Query!
Country [166]
0
0
Japan
Query!
State/province [166]
0
0
Imabari-shi
Query!
Country [167]
0
0
Japan
Query!
State/province [167]
0
0
Itoshima-shi
Query!
Country [168]
0
0
Japan
Query!
State/province [168]
0
0
Kasugai-shi
Query!
Country [169]
0
0
Japan
Query!
State/province [169]
0
0
Kawanishi-shi
Query!
Country [170]
0
0
Japan
Query!
State/province [170]
0
0
Kishiwada-shi
Query!
Country [171]
0
0
Japan
Query!
State/province [171]
0
0
Kitakyushu-shi
Query!
Country [172]
0
0
Japan
Query!
State/province [172]
0
0
Kochi-shi
Query!
Country [173]
0
0
Japan
Query!
State/province [173]
0
0
Kyoto-shi
Query!
Country [174]
0
0
Japan
Query!
State/province [174]
0
0
Maebashi-shi
Query!
Country [175]
0
0
Japan
Query!
State/province [175]
0
0
Matsudo-shi
Query!
Country [176]
0
0
Japan
Query!
State/province [176]
0
0
Matsumoto-shi
Query!
Country [177]
0
0
Japan
Query!
State/province [177]
0
0
Matsuyama-shi
Query!
Country [178]
0
0
Japan
Query!
State/province [178]
0
0
Meguro-ku
Query!
Country [179]
0
0
Japan
Query!
State/province [179]
0
0
Minato-ku
Query!
Country [180]
0
0
Japan
Query!
State/province [180]
0
0
Nagoya-shi
Query!
Country [181]
0
0
Japan
Query!
State/province [181]
0
0
Nakagami-gun
Query!
Country [182]
0
0
Japan
Query!
State/province [182]
0
0
Niigata-shi
Query!
Country [183]
0
0
Japan
Query!
State/province [183]
0
0
Oita-shi
Query!
Country [184]
0
0
Japan
Query!
State/province [184]
0
0
Onga-gun
Query!
Country [185]
0
0
Japan
Query!
State/province [185]
0
0
Osaka-shi
Query!
Country [186]
0
0
Japan
Query!
State/province [186]
0
0
Saga-shi
Query!
Country [187]
0
0
Japan
Query!
State/province [187]
0
0
Sapporo-shi
Query!
Country [188]
0
0
Japan
Query!
State/province [188]
0
0
Sendai-shi
Query!
Country [189]
0
0
Japan
Query!
State/province [189]
0
0
Shinagawa-ku
Query!
Country [190]
0
0
Japan
Query!
State/province [190]
0
0
Shinjuku-ku
Query!
Country [191]
0
0
Japan
Query!
State/province [191]
0
0
Takamatsu-shi
Query!
Country [192]
0
0
Japan
Query!
State/province [192]
0
0
Takasaki-shi
Query!
Country [193]
0
0
Japan
Query!
State/province [193]
0
0
Tokorozawa-shi
Query!
Country [194]
0
0
Japan
Query!
State/province [194]
0
0
Toshima-ku
Query!
Country [195]
0
0
Japan
Query!
State/province [195]
0
0
Tsuchiura-shi
Query!
Country [196]
0
0
Japan
Query!
State/province [196]
0
0
Yokohama-shi
Query!
Country [197]
0
0
Korea, Republic of
Query!
State/province [197]
0
0
Busan
Query!
Country [198]
0
0
Korea, Republic of
Query!
State/province [198]
0
0
Gwangju
Query!
Country [199]
0
0
Korea, Republic of
Query!
State/province [199]
0
0
Incheon
Query!
Country [200]
0
0
Korea, Republic of
Query!
State/province [200]
0
0
Seongnam-si
Query!
Country [201]
0
0
Korea, Republic of
Query!
State/province [201]
0
0
Seoul
Query!
Country [202]
0
0
Korea, Republic of
Query!
State/province [202]
0
0
Ulsan
Query!
Country [203]
0
0
Lithuania
Query!
State/province [203]
0
0
Alytus
Query!
Country [204]
0
0
Lithuania
Query!
State/province [204]
0
0
Kaunas
Query!
Country [205]
0
0
Lithuania
Query!
State/province [205]
0
0
Klaipeda
Query!
Country [206]
0
0
Lithuania
Query!
State/province [206]
0
0
Panevezys
Query!
Country [207]
0
0
Lithuania
Query!
State/province [207]
0
0
Siauliai
Query!
Country [208]
0
0
Lithuania
Query!
State/province [208]
0
0
Vilnius
Query!
Country [209]
0
0
Mexico
Query!
State/province [209]
0
0
Chihuahua
Query!
Country [210]
0
0
Mexico
Query!
State/province [210]
0
0
Cuautitlan Izcalli
Query!
Country [211]
0
0
Mexico
Query!
State/province [211]
0
0
Culiacan
Query!
Country [212]
0
0
Mexico
Query!
State/province [212]
0
0
Guadalajara
Query!
Country [213]
0
0
Mexico
Query!
State/province [213]
0
0
Merida
Query!
Country [214]
0
0
Mexico
Query!
State/province [214]
0
0
Mexico
Query!
Country [215]
0
0
Mexico
Query!
State/province [215]
0
0
Monterrey
Query!
Country [216]
0
0
Mexico
Query!
State/province [216]
0
0
Zapopan, Jalisco
Query!
Country [217]
0
0
Netherlands
Query!
State/province [217]
0
0
Almelo
Query!
Country [218]
0
0
Netherlands
Query!
State/province [218]
0
0
Almere
Query!
Country [219]
0
0
Netherlands
Query!
State/province [219]
0
0
Amsterdam
Query!
Country [220]
0
0
Netherlands
Query!
State/province [220]
0
0
Apeldoorn
Query!
Country [221]
0
0
Netherlands
Query!
State/province [221]
0
0
Arnhem
Query!
Country [222]
0
0
Netherlands
Query!
State/province [222]
0
0
Beek
Query!
Country [223]
0
0
Netherlands
Query!
State/province [223]
0
0
Delft
Query!
Country [224]
0
0
Netherlands
Query!
State/province [224]
0
0
EDE
Query!
Country [225]
0
0
Netherlands
Query!
State/province [225]
0
0
Eindhoven
Query!
Country [226]
0
0
Netherlands
Query!
State/province [226]
0
0
Harderwijk
Query!
Country [227]
0
0
Netherlands
Query!
State/province [227]
0
0
Heerlen
Query!
Country [228]
0
0
Netherlands
Query!
State/province [228]
0
0
Hilversum
Query!
Country [229]
0
0
Netherlands
Query!
State/province [229]
0
0
Hoofddorp
Query!
Country [230]
0
0
Netherlands
Query!
State/province [230]
0
0
Hoogeveen
Query!
Country [231]
0
0
Netherlands
Query!
State/province [231]
0
0
Hoorn
Query!
Country [232]
0
0
Netherlands
Query!
State/province [232]
0
0
Maastricht
Query!
Country [233]
0
0
Netherlands
Query!
State/province [233]
0
0
Nijmegen
Query!
Country [234]
0
0
Netherlands
Query!
State/province [234]
0
0
Rotterdam
Query!
Country [235]
0
0
Netherlands
Query!
State/province [235]
0
0
Schiedam
Query!
Country [236]
0
0
Netherlands
Query!
State/province [236]
0
0
Sneek
Query!
Country [237]
0
0
Netherlands
Query!
State/province [237]
0
0
Tilburg
Query!
Country [238]
0
0
Netherlands
Query!
State/province [238]
0
0
Utrecht
Query!
Country [239]
0
0
Netherlands
Query!
State/province [239]
0
0
Venlo
Query!
Country [240]
0
0
Netherlands
Query!
State/province [240]
0
0
Zoetermeer
Query!
Country [241]
0
0
Netherlands
Query!
State/province [241]
0
0
Zwijndrecht
Query!
Country [242]
0
0
New Zealand
Query!
State/province [242]
0
0
Auckland
Query!
Country [243]
0
0
New Zealand
Query!
State/province [243]
0
0
Christchurch
Query!
Country [244]
0
0
New Zealand
Query!
State/province [244]
0
0
Havelock North
Query!
Country [245]
0
0
New Zealand
Query!
State/province [245]
0
0
Rotorua
Query!
Country [246]
0
0
New Zealand
Query!
State/province [246]
0
0
Wellington
Query!
Country [247]
0
0
Poland
Query!
State/province [247]
0
0
Bialystok
Query!
Country [248]
0
0
Poland
Query!
State/province [248]
0
0
Chorzów
Query!
Country [249]
0
0
Poland
Query!
State/province [249]
0
0
Elblag
Query!
Country [250]
0
0
Poland
Query!
State/province [250]
0
0
Gdansk
Query!
Country [251]
0
0
Poland
Query!
State/province [251]
0
0
Gdynia
Query!
Country [252]
0
0
Poland
Query!
State/province [252]
0
0
Katowice
Query!
Country [253]
0
0
Poland
Query!
State/province [253]
0
0
Krakow
Query!
Country [254]
0
0
Poland
Query!
State/province [254]
0
0
Kraków
Query!
Country [255]
0
0
Poland
Query!
State/province [255]
0
0
Lodz
Query!
Country [256]
0
0
Poland
Query!
State/province [256]
0
0
Lublin
Query!
Country [257]
0
0
Poland
Query!
State/province [257]
0
0
Oswiecim
Query!
Country [258]
0
0
Poland
Query!
State/province [258]
0
0
Parczew
Query!
Country [259]
0
0
Poland
Query!
State/province [259]
0
0
Piaseczno
Query!
Country [260]
0
0
Poland
Query!
State/province [260]
0
0
Poznan
Query!
Country [261]
0
0
Poland
Query!
State/province [261]
0
0
Pulawy
Query!
Country [262]
0
0
Poland
Query!
State/province [262]
0
0
Ruda Slaska
Query!
Country [263]
0
0
Poland
Query!
State/province [263]
0
0
Rzeszów
Query!
Country [264]
0
0
Poland
Query!
State/province [264]
0
0
Sobótka
Query!
Country [265]
0
0
Poland
Query!
State/province [265]
0
0
Sopot
Query!
Country [266]
0
0
Poland
Query!
State/province [266]
0
0
Staszów
Query!
Country [267]
0
0
Poland
Query!
State/province [267]
0
0
Torun
Query!
Country [268]
0
0
Poland
Query!
State/province [268]
0
0
Warszawa
Query!
Country [269]
0
0
Poland
Query!
State/province [269]
0
0
Wroclaw
Query!
Country [270]
0
0
Poland
Query!
State/province [270]
0
0
Zamosc
Query!
Country [271]
0
0
Poland
Query!
State/province [271]
0
0
Zgierz
Query!
Country [272]
0
0
Poland
Query!
State/province [272]
0
0
Lódz
Query!
Country [273]
0
0
Russian Federation
Query!
State/province [273]
0
0
Barnaul
Query!
Country [274]
0
0
Russian Federation
Query!
State/province [274]
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Kemerovo
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Omsk
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Russian Federation
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Orenburg
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Russian Federation
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Perm
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Russian Federation
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Rostov-na-Donu
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Russian Federation
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Ryazan
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saint-Petersburg
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Russian Federation
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St Petersburg
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Russian Federation
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St-Petersburg
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Russian Federation
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St. Petersburg
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Russian Federation
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Tomsk
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Russian Federation
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Yaroslavl
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South Africa
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Bloemfontein
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South Africa
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Breyton
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Brits
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Cape Town
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Centurion
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Durban
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George
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South Africa
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Johannesburg
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South Africa
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Krugersdorp
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South Africa
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Kuilsrivier
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South Africa
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Mamelodi East
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South Africa
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Middelburg
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South Africa
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Moloto
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South Africa
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Paarl
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South Africa
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Port Elizabeth
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South Africa
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Potchefstroom
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South Africa
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Pretoria
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South Africa
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Somerset West
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South Africa
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Soweto
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South Africa
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Stanger
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South Africa
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Verulam
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South Africa
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Worcester
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Taiwan
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Kaohsiung
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Taiwan
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Taipei
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Ukraine
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Cherkasy
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kharkiv Region
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Ukraine
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Kyiv
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Ukraine
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Lutsk
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Ukraine
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Lviv
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Ukraine
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Mykolaiv
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Ukraine
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Odesa
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Ukraine
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Poltava
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Ukraine
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Uzhhorod
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Ukraine
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Vinnytsia
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Ukraine
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Zaporizhzhia
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Ukraine
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Zhytomyr
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United Kingdom
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Airdrie
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United Kingdom
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Bournemouth
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Cardiff
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United Kingdom
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Chelmsford
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Chorley
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United Kingdom
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East Kilbride
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Edgbaston
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Edinburgh
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Exeter
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Glasgow
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Hexham
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Leicester
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Liverpool
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London
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Manchester
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Reading
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Romford
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Stevenage
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Torquay
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Other collaborator category [1]
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Other
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Name [1]
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The Cleveland Clinic
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Other
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IQVIA RDS Inc.
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Ethics approval
Ethics application status
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Summary
Brief summary
The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL and high risk for CVD to be randomized 1:1 to either corn oil + statin or Epanova + statin, once daily, for approximately 3-5 years as determined when the number of MACE outcomes is reached.
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Trial website
https://clinicaltrials.gov/study/NCT02104817
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Trial related presentations / publications
Nissen SE, Lincoff AM, Wolski K, Ballantyne CM, Kastelein JJP, Ridker PM, Ray KK, McGuire DK, Mozaffarian D, Koenig W, Davidson MH, Garcia M, Katona BG, Himmelmann A, Loss LE, Poole M, Menon V, Nicholls SJ. Association Between Achieved omega-3 Fatty Acid Levels and Major Adverse Cardiovascular Outcomes in Patients With High Cardiovascular Risk: A Secondary Analysis of the STRENGTH Trial. JAMA Cardiol. 2021 Aug 1;6(8):910-917. doi: 10.1001/jamacardio.2021.1157. Nicholls SJ, Lincoff AM, Garcia M, Bash D, Ballantyne CM, Barter PJ, Davidson MH, Kastelein JJP, Koenig W, McGuire DK, Mozaffarian D, Ridker PM, Ray KK, Katona BG, Himmelmann A, Loss LE, Rensfeldt M, Lundstrom T, Agrawal R, Menon V, Wolski K, Nissen SE. Effect of High-Dose Omega-3 Fatty Acids vs Corn Oil on Major Adverse Cardiovascular Events in Patients at High Cardiovascular Risk: The STRENGTH Randomized Clinical Trial. JAMA. 2020 Dec 8;324(22):2268-2280. doi: 10.1001/jama.2020.22258.
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Public notes
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Contacts
Principal investigator
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Steven Nissen, MD
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The Cleveland Clinic
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Contact person for scientific queries
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?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request 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 shared.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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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://astrazenecagroup-dt.pharmacm.com/DT/Home
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/17/NCT02104817/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/17/NCT02104817/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/NCT02104817