Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Type IIa and IIb Hypercholesterolaemic Patients
NCT ID: NCT00631189
Last Updated: 2013-11-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
668 participants
INTERVENTIONAL
2007-10-31
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Rosuvastatin and Pravastatin
Rosuvastatin
5mg oral
Pravastatin
40mg oral
2
Rosuvastatin and Atorvastatin
Rosuvastatin
5mg oral
Atorvastatin
10mg oral
Interventions
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Rosuvastatin
5mg oral
Pravastatin
40mg oral
Atorvastatin
10mg oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* hypertriglyceridaemia (TG ≥ 4 g/l)
* subjects at high cardiovascular risk according to the AFSSAPS 2005 definition (coronary artery disease or history of documented vascular disease, high cardiovascular risk type 2 diabetes, subject in primary prevention with a 10-year CHD risk \> 20%)
* history of adverse events or hypersensitivity to an HMG Co-A reductase inhibitor (particularly a history of myopathy)
* concomitant use of any drugs not authorized during the study
* active liver disease with elevation of serum transaminases (ASAT, ALAT) more than twice the upper limit of normal
* CPK more than 3 times the upper limit of normal
* moderate or severe renal failure (creatinine clearance \< 6 ml/min)
* poorly controlled hypothyroidism; poorly controlled hypertension (DBP \> 95 mm Hg and/or SBP \> 180 mm Hg)
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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AstraZeneca
Principal Investigators
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Michel Farnier, MD
Role: PRINCIPAL_INVESTIGATOR
Le Point Medical - Rond Point du Jour
Locations
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Research Site
Aix-en-Provence, , France
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Allaire, , France
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Amiens, , France
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Ancerville, , France
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Angers, , France
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Annecy, , France
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Anzin, , France
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Arles, , France
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Arthez-de-Béarn, , France
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Aspach-le-Bas, , France
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Aubagne, , France
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Auchel, , France
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Bailleul, , France
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Balma, , France
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Beaucaire, , France
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Belfort, , France
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Bersée, , France
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Bézenet, , France
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Béziers, , France
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Biarritz, , France
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Blois, , France
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Bondues, , France
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Bondy, , France
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Bordeaux, , France
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Brignoud, , France
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Bruay-la-Buissière, , France
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Bruges, , France
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Bœrsch, , France
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Cabanac-et-Villagrains, , France
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Cadaujac, , France
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Caen, , France
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Cannes La Bocca, , France
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Carnon-Plage, , France
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Caylus, , France
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Cernay, , France
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Cestas, , France
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Champcueil, , France
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Chanceaux-sur-Choisille, , France
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Chilly-Mazarin, , France
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Clary, , France
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Collioure, , France
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Colombier-Fontaine, , France
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Colomiers, , France
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Coulonieix Chamiers, , France
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Crécy-la-Chapelle, , France
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Crotenay, , France
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Cuise-la-Motte, , France
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Derval, , France
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Dijon, , France
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Eckbolsheim, , France
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Eckwersheim, , France
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Épernay, , France
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Épinal, , France
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Étang-sur-Arroux, , France
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Évreux, , France
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Fargues-Saint-Hilaire, , France
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Folembray, , France
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Fos-sur-Mer, , France
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Franconville, , France
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Gamarde-les-Bains, , France
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Gambsheim, , France
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Gradignan, , France
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Grand-Couronne, , France
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Grendelbruch, , France
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Guise, , France
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Harnes, , France
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Horbourg-Wihr, , France
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Is-sur-Tille, , France
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Ivry-sur-Seine, , France
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Jarville-la-Malgrange, , France
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Jeumont, , France
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La Ciotat, , France
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La Courneuve, , France
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La Crèche, , France
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La Francheville, , France
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Lacrouzette, , France
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Lamagistère, , France
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Laval, , France
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Le Bouscat, , France
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Le Cannet, , France
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Le Passage, , France
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Les Issambres, , France
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Léognan, , France
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Lille, , France
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Lucheux, , France
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Marcq-en-Barœul, , France
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Marseille, , France
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Maslacq, , France
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Mauguio, , France
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Meaux-beauval, , France
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Mennecy, , France
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Mensignac, , France
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Merlimont, , France
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Metz, , France
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Miramont-de-Guyenne, , France
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Mittersheim, , France
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Monfort En Chalosse, , France
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Monguilhem, , France
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Mont-de-Marsan, , France
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Montauroux, , France
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Montbéliard, , France
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Monteux, , France
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Montfrin, , France
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Montigny-lès-Metz, , France
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Montpellier, , France
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Moreuil, , France
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Muespach, , France
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Nancy, , France
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Nogent-sur-Marne, , France
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Noyon, , France
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Oberhausbergen, , France
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Orchamps, , France
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Palau-del-Vidre, , France
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Paris, , France
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Pau, , France
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Pauillac, , France
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Périgueux, , France
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Pfulgriesheim, , France
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Phalempin, , France
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Pont-à-Mousson, , France
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Pouilly-en-Auxois, , France
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Poussan, , France
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Pradines, , France
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Puteaux, , France
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Quimperlé, , France
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Rognac, , France
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Rohrwiller, , France
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Roncq, , France
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Roquevaire, , France
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Roubaix, , France
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Saint-Etienne, , France
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Saint-Émilion, , France
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Saint-Étienne-de-Montluc, , France
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Saint-Girons, , France
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Saint-Jean-de-Braye, , France
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Saint-Leu-la-Forêt, , France
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Saint-Martin-d'Oney, , France
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Saint-Médard-en-Jalles, , France
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Saint-Morillon, , France
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Saint-Rémy, , France
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Saint-Rémy-de-Provence, , France
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Salles, , France
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Sarlat-la-Canéda, , France
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Semur-en-Auxois, , France
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Serres-Castet, , France
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Soissons, , France
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Sorcy-Saint-Martin, , France
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Strasbourg, , France
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Tarare, , France
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Targon, , France
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Tartas, , France
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Tassin-la-Demi-Lune, , France
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Thônes, , France
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Thun-Saint-Amand, , France
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Toulon, , France
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Toulouse, , France
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Trie-sur-Baïse, , France
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Varces-Allières-et-Risset, , France
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Vatan, , France
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Vence, , France
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Vélizy-Villacoublay, , France
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Vieux-Boucau-les-Bains, , France
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Villard-Bonnot, , France
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Villette-d'Anthon, , France
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Viry-Châtillon, , France
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Wasselonne, , France
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Wattignies, , France
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Wattrelos, , France
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Yerres, , France
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Yffiniac, , France
Countries
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Other Identifiers
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EudraCT No 2006-006697-15
Identifier Type: -
Identifier Source: secondary_id
D3560L00068
Identifier Type: -
Identifier Source: org_study_id