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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00882336
Other study ID # NIS-CEU-DUM-2008/1
Secondary ID
Status Completed
Phase N/A
First received April 15, 2009
Last updated October 28, 2009
Start date May 2009
Est. completion date October 2009

Study information

Verified date October 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Austria: EthikkommissionSwitzerland: EthikkommissionGermany: Ethics CommissionTurkey: Ethics CommitteeUnited Kingdom: Research Ethics CommitteeUnited Kingdom: National Health ServiceBelgium: Institutional Review BoardSweden: Regional Ethical Review BoardNorway:National Committee for Medical and Health Research EthicsFrance: Institutional Ethical CommitteeFrance: French Data Protection AuthorityGreece: Ethics CommitteeGreece: Ministry of Health and WelfareSpain: Ethics CommitteeRussia: Ethics Committee
Study type Observational

Clinical Trial Summary

The main objective of this study is to describe the management of patients with cardiovascular risk factors in primary prevention among different European countries.

The patient's participation consists of a single study visit during a routine visit of the patient to the clinic/office.

Study variables will be measured:

- By an interview between physician and patient during the visit and/or available medical records' information: social and demographic patient characteristics, relevant family medical history, current medication.

- By questions asked to the physician: physician perception of patients' CV risk factor, guidelines adherence and cost-containment.

- By measurement performed to the patient during the visit: weight, height, BMI, waist and hip circumference will be measured.

- CV risk factors (blood parameters) will be measured by collecting available data documented within the last year in the medical records and by the collection and analyses of a blood sample during the visit.


Recruitment information / eligibility

Status Completed
Enrollment 7200
Est. completion date October 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Provision of informed consent.

- Patients 50+ years old, with at least one additional CV risk factor (with no previous CV event or hospitalisation for a CV event) from Primary Care or hospital outpatient clinic.

Exclusion Criteria:

- Subjects who are unwilling or unable to provide informed consent

- Previous CV disease event or hospitalisation for a CV event

- Current participation in a clinical trial

Study Design

Time Perspective: Cross-Sectional


Locations

Country Name City State
Austria Research Site Alland
Austria Research Site Bad VOslau
Austria Research Site Baden bei Wien
Austria Research Site Bierbaum am Auersbach
Austria Research Site Bludenz
Austria Research Site Deutsch Jahrndorf
Austria Research Site Feldkirch
Austria Research Site Forstau
Austria Research Site Frankenmarkt
Austria Research Site FUrstenfeld
Austria Research Site Gerasdorf bei Wien
Austria Research Site Gleisdorf
Austria Research Site Graz
Austria Research Site Graz, Geidorf
Austria Research Site Graz, Gries
Austria Research Site Graz, Strassgang
Austria Research Site Graz, Waltendorf
Austria Research Site Gross-Enzersdorf
Austria Research Site Guntramsdorf
Austria Research Site GUssing
Austria Research Site Haid bei Ansfelden
Austria Research Site Hallein
Austria Research Site Handenberg
Austria Research Site Hard, Vbg
Austria Research Site Hermagor
Austria Research Site Hohenau an der March
Austria Research Site Innsbruck
Austria Research Site Jenbach
Austria Research Site Judendorf-Strassengel
Austria Research Site Kapfenberg
Austria Research Site Kaprun
Austria Research Site Klagenfurt, St. Martin
Austria Research Site Korneuburg
Austria Research Site KOstendorf / Sbg
Austria Research Site Kraig
Austria Research Site Krems an der Donau
Austria Research Site Laab im Walde
Austria Research Site Lassee
Austria Research Site Linz, Donau
Austria Research Site Minihof-Liebau
Austria Research Site MOdling
Austria Research Site Neudau
Austria Research Site Neumarkt
Austria Research Site Neunkirchen
Austria Research Site Neustadtl-Markt
Austria Research Site Niklasdorf
Austria Research Site Ort im Innkreis
Austria Research Site Pernitz
Austria Research Site POggstall
Austria Research Site POlfing-Brunn
Austria Research Site Preding
Austria Research Site Pyhra, Bez. St. POlten
Austria Research Site Rankweil
Austria Research Site Reichenau im MUhlkreis
Austria Research Site Salzburg
Austria Research Site Sankt POlten
Austria Research Site SchArding Innere Stadt
Austria Research Site Seewalchen am Attersee
Austria Research Site SOlden
Austria Research Site St. Leonhard am Forst
Austria Research Site St. Veit an der Glan
Austria Research Site Stainz
Austria Research Site Stegersbach
Austria Research Site Steinakirchen am Forst
Austria Research Site Steyr
Austria Research Site Straning
Austria Research Site Tulfes
Austria Research Site Villach-Innere Stadt
Austria Research Site VOcklabruck
Austria Research Site Waidhofen an der Thaya
Austria Research Site Waizenkirchen
Austria Research Site Weilbach, OO
Austria Research Site Wels
Austria Research Site Wien
Austria Research Site Wien, Alsergrund
Austria Research Site Wien, DObling
Austria Research Site Wien, Donaustadt
Austria Research Site Wien, Floridsdorf
Austria Research Site Wien, Hernals
Austria Research Site Wien, Innere Stadt
Austria Research Site Wien, Josefstadt
Austria Research Site Wien, Landstrasse
Austria Research Site Wien, Leopoldstadt
Austria Research Site Wien, Mariahilf
Austria Research Site Wien, Meidling
Austria Research Site Wien, Neubau
Austria Research Site Wien, Ottakring
Austria Research Site Wien, Penzing
Austria Research Site Wiener Neustadt
Austria Research Site Ziersdorf
Belgium Research Site Aalst
Belgium Research Site Aalter
Belgium Research Site Anthee
Belgium Research Site ATH
Belgium Research Site Beauvechain
Belgium Research Site Bellaire
Belgium Research Site Berchem (antwerpen)
Belgium Research Site Braine-le-comte
Belgium Research Site Brugge
Belgium Research Site Bruxelles
Belgium Research Site Ceroux-Mousty
Belgium Research Site Champion
Belgium Research Site Chimay
Belgium Research Site Cul-des-sarts
Belgium Research Site Deurne (antwerpen)
Belgium Research Site Eeklo
Belgium Research Site Erpe
Belgium Research Site Forest
Belgium Research Site Gent
Belgium Research Site Geraardsbergen
Belgium Research Site Gooik
Belgium Research Site Gosselies
Belgium Research Site Ham-sur-heure
Belgium Research Site Hasselt
Belgium Research Site Herentals
Belgium Research Site Jambes (namur)
Belgium Research Site Kapelle-op-den-bos
Belgium Research Site Kortrijk
Belgium Research Site Kortrijk-dutsel
Belgium Research Site Kruishoutem
Belgium Research Site Leignon
Belgium Research Site Leuven
Belgium Research Site Liernu
Belgium Research Site Linkebeek
Belgium Research Site Lummen
Belgium Research Site Maasmechelen
Belgium Research Site Maillen
Belgium Research Site MOL
Belgium Research Site Molenstede
Belgium Research Site Moorsel
Belgium Research Site Nederbrakel
Belgium Research Site Neupre
Belgium Research Site Oosteeklo
Belgium Research Site Ottignies
Belgium Research Site Oudenaarde
Belgium Research Site Robertville
Belgium Research Site Roeselare
Belgium Research Site Sambreville
Belgium Research Site Sint-andries
Belgium Research Site Sint-niklaas
Belgium Research Site Sint-truiden
Belgium Research Site St-maria-oudenhove (zot.)
Belgium Research Site Strepy-bracquegnies
Belgium Research Site Thieusies
Belgium Research Site Tongeren
Belgium Research Site Vaux-sous-chevremont
Belgium Research Site Velm
Belgium Research Site Verviers
Belgium Research Site Veurne
Belgium Research Site Villers-la-ville
Belgium Research Site Vivegnis
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Belgium Research Site Westouter
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Germany Research Site Wasserburg a. Inn
Germany Research Site Wegberg
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Greece Research Site Agia Marina
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Greece Research Site Lehaina
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Greece Research Site Porto Rafti
Greece Research Site Stoupa
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Greece Research Site Veroia
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Norway Research Site Alesund
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Norway Research Site Storen
Norway Research Site Tynset
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Russian Federation Research Site Krasnodar
Russian Federation Research Site Moscow
Russian Federation Research Site St. Petersburg
Spain Research Site A Coruna
Spain Research Site Abadin (casco Urbano) - Lugo
Spain Research Site Aceuchal - Badajoz
Spain Research Site Ademuz
Spain Research Site Alacant
Spain Research Site Albacete
Spain Research Site Alhaurin El Grande-malaga
Spain Research Site Arzua-a Coruna
Spain Research Site As Pontes - A Coruna
Spain Research Site Avila
Spain Research Site Aviles - Asturias
Spain Research Site Barruelo de Santullan - Palencia
Spain Research Site Beas de Segura - Jaen
Spain Research Site Begonte - Lugo
Spain Research Site Bilbao - Vizcaya
Spain Research Site Blanca - Murcia
Spain Research Site Boadilla Del Monte - Madrid
Spain Research Site Bohonal de Ibor - C?ceres
Spain Research Site Bonavista - Tarragona
Spain Research Site Calpe- Alicante
Spain Research Site Castelldefels - Barcelona
Spain Research Site Castellon de La Plana
Spain Research Site Ceuta
Spain Research Site Cieza - Murcia
Spain Research Site Ciudad Real
Spain Research Site Cornella de Llobregat - Barcelona
Spain Research Site Cuenca
Spain Research Site Daimiel - Ciudad Real
Spain Research Site Eivissa - Illes Balears
Spain Research Site El Prat de Llobregat - Barcelona
Spain Research Site Elda-alicante
Spain Research Site Figueres - Girona
Spain Research Site Granada
Spain Research Site Guenes - Vizcaya
Spain Research Site Huelma - Jaen
Spain Research Site Huelva
Spain Research Site Huesca
Spain Research Site Jaen
Spain Research Site L'alfas Del Pi
Spain Research Site L'hospitalet de Llobregat - Barcelona
Spain Research Site La Linea de La Concepcion - Cadiz
Spain Research Site La Nucia-alicante
Spain Research Site La Roca Del Vall?s - Barcelona
Spain Research Site La Victoria -santa Cruz de Tenerife
Spain Research Site Las Palmas de Gran Canaria
Spain Research Site Leganes - Madrid
Spain Research Site Leon
Spain Research Site Lepe - Huelva
Spain Research Site Lerma - Burgos
Spain Research Site Llica D'amunt - Barcelona
Spain Research Site Luceni - Zaragoza
Spain Research Site Madrid
Spain Research Site Majadahonda - Madrid
Spain Research Site Malaga
Spain Research Site Manzanares - Ciudad Real
Spain Research Site Mataro - Barcelona
Spain Research Site Medina de Rioseco
Spain Research Site Mombeltran - Avila
Spain Research Site Moron de La Frontera - Sevilla
Spain Research Site Mostoles - Madrid
Spain Research Site Murias (mieres) - Asturias
Spain Research Site Navarres - Valencia
Spain Research Site Olite-navarra
Spain Research Site Ourense
Spain Research Site Palma de Mallorca - Illes Balears
Spain Research Site Pamplona-navarra
Spain Research Site Petrer - Alicante
Spain Research Site Redondela - Pontevedra
Spain Research Site Ronda-malaga
Spain Research Site San Bartolome - Orihuela - Alicante
Spain Research Site San Sebasti?n
Spain Research Site Santa Cruz de Mudela - Ciudad Real
Spain Research Site Santiago de Compostela - A Coruna
Spain Research Site Segorbe - Castellon
Spain Research Site Sevilla
Spain Research Site Soria
Spain Research Site Soutomaior - Pontevedra
Spain Research Site Tarragona
Spain Research Site Terrassa - Barcelona
Spain Research Site Tolosa-guipuzcoa
Spain Research Site Torrejon de Ardoz - Madrid
Spain Research Site Tosa de Mar - Girona
Spain Research Site Tudela - Navarra
Spain Research Site Valdemoro - Madrid
Spain Research Site Valencia
Spain Research Site Valladolid
Spain Research Site Vigo - Pontevedra
Spain Research Site Vilagarcia-pontevedra
Spain Research Site Vilassar de Mar- Barcelona
Spain Research Site Villaseca de La Sagra - Toledo
Spain Research Site Zaragoza
Sweden Research Site Angelholm
Sweden Research Site Atvidaberg
Sweden Research Site Bjarred
Sweden Research Site Boden
Sweden Research Site Bollnas
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United Kingdom Research Site Bridport
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United Kingdom Research Site Brough
United Kingdom Research Site Bude
United Kingdom Research Site Burntwood
United Kingdom Research Site Calne
United Kingdom Research Site Camberley
United Kingdom Research Site Camborne
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United Kingdom Research Site Chippenham
United Kingdom Research Site Chislehurst
United Kingdom Research Site Cleethorpes
United Kingdom Research Site Cowbridge
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United Kingdom Research Site Crawley
United Kingdom Research Site Croydon
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United Kingdom Research Site Dawlish
United Kingdom Research Site Doncaster
United Kingdom Research Site Dumfries
United Kingdom Research Site Dunfermline
United Kingdom Research Site Edgware
United Kingdom Research Site Edinburgh
United Kingdom Research Site ELY
United Kingdom Research Site Enfield
United Kingdom Research Site Epsom
United Kingdom Research Site Exeter
United Kingdom Research Site Falmouth
United Kingdom Research Site Frome
United Kingdom Research Site Gillingham
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United Kingdom Research Site Harrow
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United Kingdom Research Site Leven
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United Kingdom Research Site Louth
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United Kingdom Research Site Northampton
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United Kingdom Research Site Paignton
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United Kingdom Research Site Skelmersdale
United Kingdom Research Site Smethwick
United Kingdom Research Site St. Leonards-on-sea
United Kingdom Research Site Stafford
United Kingdom Research Site Stratford-upon-
United Kingdom Research Site Strathaven
United Kingdom Research Site Sutton Coldfield
United Kingdom Research Site Wirral
United Kingdom Research Site Woodbridge
United Kingdom Research Site Worthing

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Greece,  Norway,  Russian Federation,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary LDL-cholesterol, systolic and diastolic blood pressure, Tot. cholesterol, Non-HDL cholesterol, HDL-cholesterol, waist and hip circumference, HbA1c Cross-sectional No
Primary Gender, age, patients with diabetes and/or hypertension (%), smoker status, family medical history. Cross-sectional No
Secondary BMI, Score based 10 year CHD mortality > 5%, High Risk patients (no. and %) Cross-sectional No
Secondary Use of concomitant medication: anticoagulant, anti hypertensive, antidiabetic, lipid-lowering drugs Cross-sectional No
Secondary Biomarkers: Apo-A1, Apo-B, Hs-CRP, Creatinine, albuminuria, uric acid, glomerular filtration rate. Cross-sectional No
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