NCT00297973

Brief Summary

Compare the reduction in Framingham's predicted 10-year risk of a coronary event (6) in patients with hypertension and at least three other cardiovascular risk factors (including diabetic patients) seen in private practice and randomized to either Caduet or usual care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,442

participants targeted

Target at P75+ for phase_4 hypertension

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_4 hypertension

Geographic Reach
1 country

384 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

First QC Date

February 27, 2006

Last Update Submit

January 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • % reduction in Framingham's predicted 10-year risk of a coronary event between V1 and V3 in the Caduet group compared to the usual care group (6) (including diabetic patients)

Secondary Outcomes (1)

  • 1. % patients changing risk category between V1 and V3 2. % reduction in Framingham's predicted 10-year risk of a coronary event (8) excluding diabetic patients 3. Clinical and biological safety during treatment period

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, 18 years of age or over, 2.Patient with hypertension and at least three other CV risk factors, 3.Hypertension, treated or not, but not at the currently recommended goals (140/90 mmHg for most patients, 130/80 mmHg for patients with diabetes or nephropathy). In case of treated hypertension, patients should be on their current treatment for at least 4 weeks before randomisation,

You may not qualify if:

  • \. Patient with a history of coronary heart disease, 2.Patients with a history of familial hypercholesterolemia, 3.Patient with malignant HTN, 4.Non-essential hypertension, 5.Known hypersensitivity to dihydropyridines, 6.Patients already receiving a dihydropyridine, 7.Known hypersensitivity to HMG-CoA-reductase inhibitors, 8.Patients currently receiving or who has received a HMG-CoA-reductase within the 3 months prior to selection, 9.Patients currently receiving or who has received a fibric acid, resins, ezetimibe, nicotinic acid and all other drug which is known to affect lipid levels, within 6 weeks prior to selection,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (384)

Pfizer Investigational Site

Abbeville, 80100, France

Location

Pfizer Investigational Site

Aire-sur-la-Lys, 62120, France

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Pfizer Investigational Site

Aix-les-Bains, 73100, France

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Pfizer Investigational Site

Alençon, 61000, France

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Pfizer Investigational Site

Allaire, 56350, France

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Pfizer Investigational Site

Amboise, 37400, France

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Pfizer Investigational Site

Amiens, 80000, France

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Pfizer Investigational Site

Amiens, 80080, France

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Pfizer Investigational Site

Amiens, 80094, France

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Pfizer Investigational Site

Andrézieux-Bouthéon, 42160, France

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Pfizer Investigational Site

Angers, 49000, France

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Pfizer Investigational Site

Annecy, 74000, France

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Annecy-le-Vieux, 74940, France

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Annemasse, 74100, France

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Pfizer Investigational Site

Anzin, 59410, France

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Appoigny, 89380, France

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Apt, 84400, France

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Argenteuil, 95100, France

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Arles, 13200, France

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Arnèke, 59285, France

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Arpajon, 91290, France

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Arsac, 33460, France

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Aubagne, 13400, France

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Auchel, 62260, France

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Audresselles, 62164, France

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Autrans, 38880, France

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Balma, 31130, France

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Bastia, 20200, France

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Bayonne, 64100, France

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Beaucaire, 30300, France

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Beaumont-lès-Valence, 26760, France

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Beaurains, 62217, France

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Beausoleil, 06240, France

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Belley, 01300, France

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Belpech, 11420, France

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Benquet, 40280, France

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Berck, 62600, France

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Bersée, 59235, France

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Béthune, 62400, France

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Béziers, 34500, France

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Pfizer Investigational Site

Biarritz, 64200, France

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Blasimon, 33540, France

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Blois, 41000, France

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Boën-sur-Lignon, 42130, France

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Bondues, 59910, France

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Bondy, 93140, France

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Bordeaux, 33000, France

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Bordeaux, 33200, France

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Bourg-Saint-Andéol, 07700, France

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Bourges, 18000, France

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Brest, 29200, France

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Bréhan, 56580, France

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Brignoud, 38190, France

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Bruay-la-Buissière, 62700, France

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Bœrsch, 67530, France

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Cabestany, 66330, France

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Caen, 14000, France

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Cagnes-sur-Mer, 06800, France

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Cannes, 06400, France

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Cannes La Bocca, 06150, France

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Carnon-Plage, 34280, France

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Castelnau Le Fez, 34170, France

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Castelsarrasin, 82100, France

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Castres, 81100, France

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Caylus, 82160, France

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Cergy, 95000, France

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Cestas, 33610, France

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Champagne-au-Mont-d'Or, 69410, France

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Chanceaux-sur-Choisille, 37390, France

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Charleville-Mézières, 08000, France

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Chartres, 28000, France

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Chatou, 78400, France

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Chelles, 77500, France

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Chenôve, 21300, France

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Chilly-Mazarin, 91380, France

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Clairac, 47320, France

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Clary, 59225, France

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Clermont-Ferrand, 63100, France

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Collioure, 66190, France

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Colombier-Fontaine, 25260, France

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Colomiers, 31770, France

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Condat-sur-Vienne, 87920, France

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Courthézon, 84350, France

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Craponne, 69290, France

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Crest, 26400, France

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Crécy-la-Chapelle, 77580, France

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Créteil, 94000, France

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Crotenay, 39300, France

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Cuise-la-Motte, 60350, France

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Denain, 59220, France

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Dijon, 21000, France

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Dugny-sur-Meuse, 55100, France

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Dunkirk, 59140, France

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Eckbolsheim, 67201, France

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Eckwersheim, 67550, France

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Échirolles, 38130, France

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Épernay, 51200, France

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Épinal, 88000, France

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Épinay-sur-Seine, 93800, France

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Étampes, 91150, France

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Étang-sur-Arroux, 71190, France

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Évreux, 27000, France

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Falaise, 14700, France

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Fayence, 83440, France

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Fenioux, 79160, France

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Ferney-Voltaire, 01210, France

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Floirac, 33270, France

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Fontaine, 38600, France

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Fontaine-lès-Dijon, 21121, France

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Fontainebleau, 77300, France

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Fontenay-sous-Bois, 94120, France

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Fontès, 34320, France

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Fos-sur-Mer, 13270, France

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Franconville, 95130, France

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Fumay, 08170, France

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Gaillefontaine, 76870, France

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Gambsheim, 67760, France

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Gap, 05000, France

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Gonesse, 95500, France

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Gonneville-la-Mallet, 76280, France

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Gradignan, 33170, France

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Grand-Couronne, 76530, France

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Grendelbruch, 67190, France

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Grenoble, 38000, France

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Pfizer Investigational Site

Grenoble, 38100, France

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Gréasque, 13850, France

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Groslay, 95410, France

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Guise, 02120, France

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Haguenau, 67500, France

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Harnes, 62440, France

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Hasparren, 64240, France

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Hautmont, 59330, France

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Hochfelden, 67270, France

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Hostens, 33125, France

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Ivry-sur-Seine, 94200, France

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Jargeau, 45150, France

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Jarville-la-Malgrange, 54140, France

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Jeumont, 59460, France

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Jeumont, 59571, France

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L'Isle-sur-la-Sorgue, 84800, France

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Pfizer Investigational Site

La Baule-Escoublac, 44500, France

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Pfizer Investigational Site

La Chapelle-des-Marais, 44410, France

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Pfizer Investigational Site

La Chapelle-sur-Erdre, 44240, France

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Pfizer Investigational Site

La Ciotat, 13600, France

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La Courneuve, 93120, France

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La Crèche, 79260, France

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La Fère, 02800, France

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Pfizer Investigational Site

La Francheville, 08000, France

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La Grande-Motte, 34280, France

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Pfizer Investigational Site

La Grande-Paroisse, 77130, France

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Pfizer Investigational Site

La Rochelle, 17000, France

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Pfizer Investigational Site

La Tour-du-Crieu, 09100, France

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Pfizer Investigational Site

La Trinité-sur-Mer, 56470, France

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Labastidette, 31600, France

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Lacrouzette, 81210, France

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Lamagistère, 82360, France

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Lamarque, 33460, France

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Langon, 33210, France

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Lattes, 34970, France

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Laval, 53000, France

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Lavernose-Lacasse, 31410, France

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Laxou, 54520, France

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Le Bourget, 93350, France

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Le Cannet, 06110, France

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Le Havre, 76600, France

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Le Havre, 76610, France

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Le Havre, 76620, France

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Lembeye, 64350, France

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Les Issambres, 83380, France

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Les Sables-d'Olonne, 85100, France

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Lesquin, 59810, France

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Liancourt, 60140, France

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Ligny-en-Barrois, 55500, France

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Lille, 59000, France

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Lille, 59800, France

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Limoges, 87000, France

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Lorient, 56100, France

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Lourdes, 65100, France

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Lucheux, 80600, France

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Luxeuil-les-Bains, 70300, France

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Lyon, 69008, France

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Lyon, 69009, France

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Mandelieu-la-Napoule, 06210, France

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Marcq-en-Barœul, 59700, France

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Marseille, 13002, France

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Marseille, 13004, France

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Marseille, 13006, France

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Marseille, 13008, France

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Pfizer Investigational Site

Marseille, 13009, France

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Pfizer Investigational Site

Marseille, 13010, France

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Pfizer Investigational Site

Marseille, 13012, France

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Marseille, 13013, France

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Marseille, 13015, France

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Martigues, 13500, France

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Masseret, 19510, France

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Mauguio, 34130, France

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Meaux Beauval, 77100, France

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Meaux-Beauval, 77100, France

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Mennecy, 91540, France

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Mensignac, 24350, France

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Merlimont, 62155, France

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Metz, 57000, France

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Mirabel-et-Blacons, 26400, France

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Miramas, 13140, France

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Miramas, 13141, France

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Miramont-de-Guyenne, 47800, France

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Mittersheim, 57930, France

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Mommenheim, 67670, France

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Mons-en-Barœul, 59370, France

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Montauroux, 83440, France

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Montbéliard, 25200, France

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Monteux, 84170, France

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Montpellier, 34000, France

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Montpellier, 34070, France

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Montreuil, 93100, France

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Montrevel-en-Bresse, 01340, France

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Moreuil, 80110, France

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Morlaix, 29600, France

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Mourenx, 64150, France

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Muespach, 68640, France

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Mulhouse, 68100, France

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Mulhouse, 68200, France

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Mundolsheim, 67450, France

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Nancy, 54000, France

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Nantes, 44000, France

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Nantes, 44100, France

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Nantes, 44200, France

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Nevers, 58000, France

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Néris-les-Bains, 03310, France

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Nice, 06 000, France

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Nice, 06000, France

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Nice, 06200, France

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Nice, 06300, France

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Niort, 79000, France

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Nogent-sur-Marne, 94130, France

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Noisiel, 77186, France

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Noyon, 60400, France

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Oberhausbergen, 67205, France

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Obernai, 67210, France

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Objat, 19130, France

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Orange, 84100, France

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Orchamps, 39700, France

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Orry-la-Ville, 60560, France

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Ossès, 64780, France

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Pacy-sur-Eure, 27210, France

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Palau-del-Vidre, 66690, France

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Paris, 75009, France

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Pfizer Investigational Site

Paris, 75012, France

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Pfizer Investigational Site

Paris, 75013, France

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Pfizer Investigational Site

Paris, 75014, France

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Paris, 75015, France

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Pfizer Investigational Site

Paris, 75017, France

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Pfizer Investigational Site

Paris, 75018, France

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Paris, 75019, France

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Paris, 75020, France

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Paris, 75116, France

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Parthenay, 79200, France

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Perpignan, 66100, France

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Pessac, 33600, France

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Petit-Couronne, 76650, France

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Pfulgriesheim, 67370, France

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Phalempin, 59133, France

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Pont-à-Mousson, 54700, France

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Portet-sur-Garonne, 31120, France

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Porto-Vecchio, 20137, France

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Poussan, 34560, France

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Pradines, 46090, France

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Précy-sur-Oise, 60460, France

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Quimperlé, 29300, France

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Rebais, 77510, France

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Reims, 51100, France

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Remiremont, 88200, France

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Rennes, 35200, France

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Rigney, 25640, France

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Rodez, 12001, France

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Rognac, 13340, France

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Rohrwiller, 67410, France

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Romans-sur-Isère, 26100, France

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Roncq, 59223, France

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Roquevaire, 13360, France

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Roubaix, 59071, France

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Roubaix, 59100, France

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Rozay-en-Brie, 77540, France

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Saint-Agrève, 07320, France

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Saint-Avold, 57500, France

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Saint-Brieuc, 22015, France

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Saint-Denis, 93200, France

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Saint-Dié, 88100, France

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Saint-Erme-Outre-et-Ramecourt, 02820, France

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Saint-Etienne, 42000, France

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Saint-Etienne, 42100, France

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Saint-Fons, 69190, France

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Saint-Germain-au-Mont-d'Or, 69650, France

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Saint-Germain-de-Marencennes, 17700, France

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Saint-Girons, 09200, France

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Saint-Jean-de-Braye, 45800, France

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Saint-Jean-de-Luz, 64500, France

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Saint-Jean-de-Maurienne, 73300, France

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Saint-Joachim, 44720, France

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Saint-Leu-d'Esserent, 60340, France

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Saint-Leu-la-Forêt, 95320, France

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Saint-Marcel-lès-Valence, 26320, France

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Saint-Martin-d'Hères, 38400, France

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Saint-Martin-d'Oney, 40090, France

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Saint-Martin-des-Champs, 50300, France

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Saint-Martin-du-Bois, 49500, France

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Saint-Morillon, 33650, France

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Saint-Ouen, 93400, France

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Saint-Ouen-l'Aumône, 95310, France

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Saint-Rambert-d'Albon, 26140, France

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Saint-Raphaël, 83700, France

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Saint-Rémy-de-Provence, 13210, France

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Saint-Saulve, 59880, France

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Saint-Sébastien-sur-Loire, 44230, France

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Saint-Sulpice-la-Pointe, 81370, France

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Saint-Tropez, 83990, France

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Saint-Yrieix-la-Perche, 87500, France

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Salles, 33770, France

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Salon-de-Provence, 13300, France

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Sanary-sur-Mer, 83110, France

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Sarlat-la-Canéda, 24200, France

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Sartrouville, 78500, France

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Schweighouse-sur-Moder, 67590, France

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Semur-en-Auxois, 21140, France

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Sevrier, 74320, France

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Sète, 34200, France

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Sélestat, 67600, France

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Soissons, 02200, France

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Solgne, 57420, France

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Ste. Maxime, 83120, France

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Ste. Suzanne, 53270, France

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Strasbourg, 67000, France

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Strasbourg, 67200, France

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Suresnes, 92150, France

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Targon, 33760, France

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Tergnier, 02700, France

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Thiant, 59224, France

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Thierville-sur-Meuse, 55840, France

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Thiviers, 24800, France

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Thônes, 74230, France

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Pfizer Investigational Site

Toul, 54200, France

Location

Pfizer Investigational Site

Toulon, 83000, France

Location

Pfizer Investigational Site

Toulon, 83200, France

Location

Pfizer Investigational Site

Toulouse, 31000, France

Location

Pfizer Investigational Site

Toulouse, 31100, France

Location

Pfizer Investigational Site

Toulouse, 31200, France

Location

Pfizer Investigational Site

Toulouse, 31400, France

Location

Pfizer Investigational Site

Toulouse, 31500, France

Location

Pfizer Investigational Site

Tours, 37000, France

Location

Pfizer Investigational Site

Trie-sur-Baïse, 65220, France

Location

Pfizer Investigational Site

Vabres-l'Abbaye, 12400, France

Location

Pfizer Investigational Site

Vacqueyras, 84190, France

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Pfizer Investigational Site

Vagney, 88120, France

Location

Pfizer Investigational Site

Valenciennes, 59300, France

Location

Pfizer Investigational Site

Valognes, 50700, France

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Pfizer Investigational Site

Valréas, 84600, France

Location

Pfizer Investigational Site

Vals-les-Bains, 07600, France

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Pfizer Investigational Site

Vandœuvre-lès-Nancy, 54500, France

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Pfizer Investigational Site

Vannes, 56000, France

Location

Pfizer Investigational Site

Varces-Allières-et-Risset, 38760, France

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Pfizer Investigational Site

Vatan, 36150, France

Location

Pfizer Investigational Site

Vence, 06140, France

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Pfizer Investigational Site

Vernet, 31810, France

Location

Pfizer Investigational Site

Vélines, 24230, France

Location

Pfizer Investigational Site

Vélizy-Villacoublay, 78140, France

Location

Pfizer Investigational Site

Vénissieux, 69200, France

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Pfizer Investigational Site

Viane, 81530, France

Location

Pfizer Investigational Site

Villard-Bonnot, 38190, France

Location

Pfizer Investigational Site

Villefranche-de-Rouergue, 12200, France

Location

Pfizer Investigational Site

Villefranche-sur-Mer, 06230, France

Location

Pfizer Investigational Site

Villefranche-sur-Saône, 69400, France

Location

Pfizer Investigational Site

Villeneuve-lès-Maguelone, 34750, France

Location

Pfizer Investigational Site

Villeparisis, 77270, France

Location

Pfizer Investigational Site

Villers-Saint-Paul, 60870, France

Location

Pfizer Investigational Site

Villette-d'Anthon, 38280, France

Location

Pfizer Investigational Site

Viry-Châtillon, 91170, France

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Pfizer Investigational Site

Vitrolles, 13127, France

Location

Pfizer Investigational Site

Vix, 85770, France

Location

Pfizer Investigational Site

Wambrechies, 59118, France

Location

Pfizer Investigational Site

Wasselonne, 67310, France

Location

Pfizer Investigational Site

Wattignies, 59139, France

Location

Pfizer Investigational Site

Wattrelos, 59150, France

Location

Pfizer Investigational Site

Witry-lès-Reims, 51420, France

Location

Pfizer Investigational Site

Yffiniac, 22120, France

Location

Related Links

MeSH Terms

Conditions

Hypertension

Interventions

Blood PressureBlood Specimen Collection

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaSpecimen HandlingClinical Laboratory TechniquesPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 27, 2006

First Posted

March 1, 2006

Study Start

February 1, 2006

Study Completion

April 1, 2007

Last Updated

January 27, 2021

Record last verified: 2021-01

Locations