HealthyNCT01308372

Cardiovascular Risk in General Practice in France: Cardiovascular Risk Week

An observational study of Healthy, run by AstraZeneca at 585 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the proportion of patients which present a high cardiovascular risk estimated by the SCORE scale, in general practice consultations of the 7 French regions (Paris area, North-East, Paris basin, West, South-West, South- East, Mediterranean area) Read more about this study

Who is it for?: Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
How many people: 9,246 participants
Where: 585 sitesFrance
Study dates: Oct 2011to Oct 2011
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Primary care

Who may be able to join

Without any personal history of coronary disease
Non treated with lipid-lowering agents
Lipid test = 1 year old
Presenting at least one cardiovascular risk
Visiting their General Practitioner

Who cannot join

None listed.

Trial locations and contacts

585 sites in 1 country.

City, postcode or hospital

300 sites in 1 country

France300 sites

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Achenheim, France
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Aizenay, France
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Albi, France
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Alençon, France
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Alès, France
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Algrange, France
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Alignan-du-Vent, France
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Allauch, France
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Alleins, France
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Allonnes, France
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Allouagne, France
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Ambès, France
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Ambleteuse, France
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Amelie Les Bains Palalda, France
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Amfreville, France
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Amiens, France
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Angers, France
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Aniche, France
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Annecy-le-Vieux, France
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Annemasse, France
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Annezin, France
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Annoeullin, France
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Anthony, France
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Antibes, France
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Anzin, France
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Arcachon, France
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Argeliers, France
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Argentan, France
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Armentières, France
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Arradon, France
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Arras, France
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Ars, France
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Asfeld, France
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Asnières-sur-Seine, France
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Aubagne, France
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Aubière, France
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Auchel, France
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Audincourt, France
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Auneau, France
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Aurillac, France
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Auxerre, France
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Avignon, France
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Avize, France
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Avord, France
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Avranches, France
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Badonviller, France
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Bailleul, France
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Bain-de-Bretagne, France
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Baixas, France
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Ballancourt, France
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Balma, France
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Bandol, France
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Banyuls de la Marenda, France
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Barbentane, France
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Basse-Goulaine, France
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Bassussarry, France
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Bazeilles, France
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Bazet, France
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Beaucouzé, France
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Beaumont-Hague, France
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Beaumont-lès-Valence, France
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Beaune-la-Rolande, France
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Beauvais, France
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Behren-lès-Forbach, France
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Belfort, France
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Belleville-sur-Meuse, France
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Bergerac, France
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Bernin, France
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Besançon, France
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Bessancourt, France
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Bétaille, France
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Bétheniville, France
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Béziers, France
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Biarritz, France
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Bitche, France
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Blagnac, France
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Blangy-sur-Bresle, France
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Blanzat, France
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Bléré, France
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Blois, France
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Boën-sur-Lignon, France
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Bois-Bernard, France
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Bolquère, France
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Bono, France
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Bonson, France
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Bordeaux, France
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Bosmie-l'Aiguille, France
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Bouguenais, France
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Bourbonne-les-Bains, France
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Bourg de Joué-sur-Erdre, France
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Bourges, France
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Bousse, France
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Boynes, France
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Brassac, France
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Bresles, France
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Brest, France
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Briançon, France
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Brie-Comte-Robert, France
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Bron, France
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Bruay-la-Buissière, France
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Bruay-sur-l'Escaut, France
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Cabannes, France
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Caen, France
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Cagnes-sur-Mer, France
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Cahagnes, France
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Calais, France
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Calonne-Ricouart, France
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Caluire-et-Cuire, France
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Cambrai, France
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Campagne-lès-Wardrecques, France
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Cancon, France
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Cannes, France
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Carnon-Plage, France
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Caromb, France
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Carpentras, France
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Carvin, France
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Castres, France
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Caudry, France
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Caunes-Minervois, France
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Cerizay, France
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Cessy, France
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Ceyrat, France
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Châlons-en-Champagne, France
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Chambéry, France
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Champagne-sur-Oise, France
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Chanceaux-sur-Choisille, France
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Chaource, France
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Châtillon-sur-Marne, France
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Chelles, France
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Chirac, France
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Claye-Souilly, France
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Clermont, France
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Clermont-Ferrand, France
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Clisson, France
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Clouange, France
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Collioure, France
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Colmar, France
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Colombey-les-Belles, France
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Colomiers, France
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Commercy, France
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Communay, France
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Cormeilles-en-Parisis, France
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Coudekerque-Branche, France
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Coulanges-la-Vineuse, France
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Courcelles-sur-Nied, France
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Cournon-d'Auvergne, France
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Coursan, France
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Crêches-sur-Saône, France
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Crécy-en-Ponthieu, France
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Créhange, France
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Crespin, France
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Cubjac, France
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Cucuron, France
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Cugnaux, France
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Dambach-la-Ville, France
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Danjoutin, France
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Denain, France
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Dessenheim, France
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Deuil-la-Barre, France
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Déville-lès-Rouen, France
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Diebling, France
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Dieppe, France
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Dijon, France
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Domène, France
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Domont, France
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Draguignan, France
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Dunières, France
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Échenoz-la-Méline, France
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Einville-au-Jard, France
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Elliant, France
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Emmerin, France
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Épinac, France
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Épinal, France
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Eragny Sur Oise, France
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Étampes-sur-Marne, France
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Évry, France
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Excideuil, France
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Eyguières, France
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Fegersheim, France
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Figeac, France
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Firminy, France
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Flavignac, France
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Fontaine-lès-Dijon, France
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Fontaine-Notre-Dame, France
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Fontenilles, France
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Fors, France
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Fos-sur-Mer, France
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Fosses, France
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Fraisses, France
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Francescas, France
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Frasne, France
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Fresnes-sur-Escaut, France
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Frontigny, France
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Frouard, France
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Gamaches, France
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Gap, France
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Gardanne, France
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Garges-lès-Gonesse, France
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Gerbéviller, France
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Gignac-la-Nerthe, France
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Givry-en-Argonne, France
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Gonesse, France
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Grasse, France
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Gréasque, France
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Grenade-sur-l’Adour, France
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Grenoble, France
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Grésy-sur-Aix, France
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Guesnain, France
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Guignicourt, France
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Guiscriff, France
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Guyancourt, France
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Hambye, France
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Hatten, France
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Hayange, France
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Hazebrouck, France
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Hellemmes-Lille, France
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Herblay-sur-Seine, France
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Héric, France
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Héricourt, France
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Herlies, France
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Holtzheim, France
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Hombourg, France
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Houilles, France
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Hyères, France
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Illkirch-Graffenstaden, France
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Issy-les-Moulineaux, France
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Ivry-sur-Seine, France
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Jardin, France
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Josnes, France
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Jouy-le-Châtel, France
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Juan-les-Pins, France
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Kurtzenhouse, France
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L'Haÿ-les-Roses, France
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L'Isle-sur-la-Sorgue, France
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La Boussac, France
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La Chabossière, France
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La Chaussée-Saint-Victor, France
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La Farlède, France
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La Forêt-sur-Sèvre, France
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La Garnache, France
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La Grand-Croix, France
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La Madeleine, France
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La Motte-Servolex, France
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La Neuville-Roy, France
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La Riche, France
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La Roche-en-Brenil, France
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La Rochelle, France
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La Saussaye, France
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La Teste-de-Buch, France
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La Tour-de-Salvagny, France
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La Turballe, France
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La Varenne-Saint-Hilaire, France
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Labouheyre, France
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Laguenne, France
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Lambersart, France
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Landeleau, France
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Landerneau, France
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Landrecies, France
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Langoiran, France
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Lapugnoy, France
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Lauzun, France
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Laval, France
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Lavardac, France
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Laventie, France
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Lavoûte-sur-Loire, France
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Laxou, France
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Lay-Saint-Christophe, France
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Le Bourget, France
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Le Cannet, France
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Le Clion-sur-Mer, France
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Le Gouray, France
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Le Grand-Lemps, France
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Le Grand-Quevilly, France
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Le Havre, France
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Le Houlme, France
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Le Lavandou, France
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Le Mée-sur-Seine, France
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Le Petit-Quevilly, France
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Le Pin-en-Mauges, France
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Le Plessis-Robinson, France
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Le Pontet, France
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Le Roc-Saint-André, France
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Le Russey, France
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Le Temple-de-Bretagne, France
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Le Vigan, France
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Lembach, France
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Les Clayes-sous-Bois, France
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Les Mureaux, France
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Les Pavillons-sous-Bois, France
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Les Sables-d'Olonne, France
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Levallois-Perret, France
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Liancourt, France
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Lieuran-lès-Béziers, France
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Liévin, France
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Lille, France
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Limoges, France
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Limoux, France
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Lingolsheim, France
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Lion-sur-Mer, France
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Loches, France

Other trials in France

About this study

Official title: Cardiovascular Risk in General Practice in France

Read the detailed description

MC MD

Conditions: Healthy
Keywords: cardiovascular risk, France, General practice, Primary prevention, Non treated patients

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01308372
Study group	Role	What they receive
1		For this group of patients, the cardiovascular risk will be evaluated by several tools: the SCORE scale, the Framingham 2008 scale d'Agostino and the 1998 scale Wilson ;

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluation of cardiovascular risk in general practice in France estimated by the SCORE scale
Measured: 1 week

Secondary outcomes (3)

Evaluation of cardiovascular risk in general practice in France estimated by the Framingham 2008 scale D'Agostino
Measured: 1 week
Evaluation of cardiovascular risk in general practice in France estimated by the Framingham 1998 scale Wilson
Measured: 1 week
Evaluation of arteries age evaluation by SCORE
Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011Oct 2011

First posted4 Mar 2011 (estimated)
Study startOct 2011
Primary completionOct 2011
Study completionOct 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 9,246 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01308372
Sponsor's protocol ID: NIS-CFR-XXX-2011/1
Status last verified: Nov 2011
First submitted: 18 Feb 2011
Last updated: 7 Nov 2011
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
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A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cardiovascular Risk in General Practice in France
ClinicalTrials.gov ID: NCT01308372
Acronym / sponsor ID: NIS-CFR-XXX-2011/1
Conditions: Healthy
Keywords: cardiovascular risk, France, General practice, Primary prevention, Non treated patients
Study type: Observational
Recruitment status: Completed
Enrolment: 9,246 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 4 Mar 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

MC MD

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
1	–	–For this group of patients, the cardiovascular risk will be evaluated by several tools: the SCORE scale, the Framingham 2008 scale d'Agostino and the 1998 scale Wilson ;

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Primary care

Key inclusion criteria (5 listed)

Without any personal history of coronary disease
Non treated with lipid-lowering agents
Lipid test = 1 year old
Presenting at least one cardiovascular risk
Visiting their General Practitioner

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Evaluation of cardiovascular risk in general practice in France estimated by the SCORE scale
Time frame: 1 week

3 secondary outcomes

Evaluation of cardiovascular risk in general practice in France estimated by the Framingham 2008 scale D'Agostino
Time frame: 1 week
Evaluation of cardiovascular risk in general practice in France estimated by the Framingham 1998 scale Wilson
Time frame: 1 week
Evaluation of arteries age evaluation by SCORE
Time frame: 1 week

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2011.

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eric BRUCKERT, Pr. principal investigator

Hôpital Pitié-Salpétrière - Service Endocrinologie-Métabolisme

Jean DALLONGEVILLE, Dr. principal investigator

Institut Pasteur de Lille - Unité d'Epidémiologie et de santé publique Inserm UMR 744

Jean FERRIERES, Pr. principal investigator

CHU Rangueil - Service de Cardiologie B - Toulouse

585 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by AstraZeneca at 585 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 585 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of cardiovascular risk in general practice in France estimated by the SCORE scale (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01308372.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2011.