Clinical trial NCT00631189: 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
Official title: Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Subjects With Type IIa and IIb Hypercholesterolaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type IIa and IIb Hypercholesterolaemia
Keywords: dyslipidemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-07
Enrollment: 668
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of Rosuvastatin 5 mg as an hypercholesterolemia treatment comparatively at 2 other statins: Pravastatin 40 mg and Atorvastatin 10 mg. Treatment efficacy will be evaluated by the percentage of LDL-C variation after 8 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* subjects presenting type IIa or IIb primary hypercholesterolaemia diagnosed for at least 3 months, in a context of primary prevention with at least two associated cardiovascular risk factors and: (i)either "naive" to all lipid-lowering therapy, (ii)or treated with a statin (treatment ongoing or stopped during the previous 8 weeks)

Exclusion Criteria:

* homozygous or heterozygous familial hypercholesterolaemia
* 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)

Primary outcomes:
measure: Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks
timeFrame: Change from baseline and after 8 weeks of treatment
Secondary outcomes:
measure: To Compare the Percentage of Patients Reaching the Overall LDL-C Goal According to the French Agency for the Safety of Health Products (AFSSAPS) 2005 Guidelines for the Management of Dyslipidaemic Patients
timeFrame: Not done
measure: To Compare the Percentage of Patients Reaching the LDL-C Goal, in Relation to the Number of Risk Factors, According to the French Agency for the Safety of Health Products (AFSSAPS) 2005 Guidelines for the Management of Dyslipidaemic Patients
timeFrame: Not done
measure: Compare the Percentage of Total Cholesterol Variation From Baseline and After 8 Weeks of Treatment
timeFrame: from baseline and after 8 weeks of treatment
measure: Compare the Percentage of HDL-C (High Density Lipoprotein Cholesterol) Variation From Baseline and After 8 Weeks of Treatment
timeFrame: After 8 weeks of treatment
measure: Compare the Percentage of Variation From Baseline Triglycerides Values and After 8 Weeks
timeFrame: Baseline and after 8 weeks of treatment
measure: Compare the Percentage of Variation From Baseline Apolipoprotein B/Apolipoprotein A1 Ratio and After 8 Weeks of Treatment
timeFrame: baseline and after 8 weeks of treatment
measure: Compare the Percentage of Variation of C-reactive Protein (CRP)
timeFrame: baseline and after 8 weeks of treatment
measure: Compare the Percentage of Variation of Phospholipase A2 (PLA2)
timeFrame: from baseline and after 8 weeks of treatment
measure: Compare the Numbers of Patients Achieving the LDL-C Goal According to the National Cholesterol Education Program Adult Treatment Panel III (NCEP) ATP III) Guidelines for the Management of Dyslipidaemic Patients
timeFrame: from baseline and after 8 weeks of treatment
measure: Compare the Numbers of Patients Achieving the LDL-C Goal According to the European Atherosclerosis Society (EAS) Guidelines for the Management of Dyslipidaemic Patients
measure: To Evaluate Clinical and Laboratory Safety
timeFrame: duration of study
Other outcomes:
Locations:
city: Aix En Provence
country: France
facility: Research Site
city: Allaire
country: France
facility: Research Site
city: Amiens
country: France
facility: Research Site
city: Ancerville
country: France
facility: Research Site
city: Angers
country: France
facility: Research Site
city: Annecy
country: France
facility: Research Site
city: Anzin
country: France
facility: Research Site
city: Arles
country: France
facility: Research Site
city: Arthez de Bearn
country: France
facility: Research Site
city: Aspach Le Bas
country: France
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city: Aubagne
country: France
facility: Research Site
city: Auchel
country: France
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city: Bailleul
country: France
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city: Balma
country: France
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city: Beaucaire
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city: Belfort
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city: Bersee
country: France
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city: Bezenet
country: France
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city: Beziers
country: France
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city: Biarritz
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city: Blois
country: France
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city: Boersch
country: France
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city: Bondues
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city: Bondy
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city: Bordeaux
country: France
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city: Brignoud
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city: Bruay La Buissiere
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city: Bruges
country: France
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city: Cabanac Et Villagrains
country: France
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city: Cadaujac
country: France
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city: Caen
country: France
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city: Cannes La Bocca
country: France
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city: Carnon
country: France
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city: Caylus
country: France
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city: Cernay
country: France
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city: Cestas
country: France
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city: Champcueil
country: France
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city: Chanceaux Sur Choisille
country: France
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city: Chilly-mazarin
country: France
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city: Clary
country: France
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city: Collioure
country: France
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city: Colombier Fontaine
country: France
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city: Colomiers
country: France
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city: Coulonieix Chamiers
country: France
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city: Crecy La Chapelle
country: France
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city: Crotenay
country: France
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city: Cuise La Motte
country: France
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city: Derval
country: France
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city: Dijon
country: France
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city: Eckbolsheim
country: France
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city: Eckwersheim
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city: Epernay
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city: Etang Sur Arroux
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city: Fargues St Hilaire
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city: Franconville La Garenne
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city: Gamarde Les Bains
country: France
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city: Grand Couronne
country: France
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city: Ivry Sur Seine
country: France
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country: France
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country: France
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country: France
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city: La Francheville
country: France
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country: France
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city: Lamagistere
country: France
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country: France
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country: France
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country: France
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city: Lille
country: France
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country: France
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city: Marcq En Baroeul
country: France
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city: Marseille
country: France
facility: Research Site
city: Maslacq
country: France
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city: Mauguio
country: France
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city: Meaux-beauval
country: France
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city: Mennecy
country: France
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city: Mensignac
country: France
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city: Merlimont
country: France
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city: Metz
country: France
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city: Miramont de Guyenne
country: France
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city: Mittersheim
country: France
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city: Monfort En Chalosse
country: France
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city: Monguilhem
country: France
facility: Research Site
city: Mont de Marsan
country: France
facility: Research Site
city: Montauroux
country: France
facility: Research Site
city: Montbeliard
country: France
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city: Monteux
country: France
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city: Montfrin
country: France
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city: Montigny Les Metz
country: France
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city: Montpellier
country: France
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city: Moreuil
country: France
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city: Muespach
country: France
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city: Nancy
country: France
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city: Nogent Sur Marne
country: France
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city: Noyon
country: France
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city: Oberhausbergen
country: France
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city: Orchamps
country: France
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city: Palau Del Vidre
country: France
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city: Paris
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city: PAU
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country: France
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country: France
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country: France
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city: Quimperle
country: France
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city: Rognac
country: France
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city: Rohrwiller
country: France
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city: Roncq
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city: Roquevaire
country: France
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city: Roubaix
country: France
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city: Saint Etienne
country: France
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city: Saint Martin D'oney
country: France
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city: Saint Medard En Jalles
country: France
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city: Saint Remy
country: France
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city: Salles
country: France
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city: Sarlat La Caneda
country: France
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city: Semur En Auxois
country: France
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city: Serres Castet
country: France
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city: Soissons
country: France
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city: Sorcy Saint Martin
country: France
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city: St Etienne de Montluc
country: France
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city: St Etienne
country: France
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city: St Girons
country: France
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city: St Jean de Braye
country: France
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city: St Leu La Foret
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city: St Morillon
country: France
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city: St Remy de Provence
country: France
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city: St. Emilion
country: France
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city: Strasbourg
country: France
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city: Tarare
country: France
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city: Targon
country: France
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city: Tartas
country: France
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city: Tassin La Demi-lune
country: France
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city: Thones
country: France
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city: Thun St Amand
country: France
facility: Research Site
city: Toulon
country: France
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city: Toulouse
country: France
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city: Trie Sur Baise
country: France
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city: Varces Allieres Et Risset
country: France
facility: Research Site
city: Vatan
country: France
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city: Velizy Villacoublay
country: France
facility: Research Site
city: Vence
country: France
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city: Vieux Boucau
country: France
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city: Villard Bonnot
country: France
facility: Research Site
city: Villette D'anthon
country: France
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city: Viry Chatillon
country: France
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city: Wasselonne
country: France
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city: Wattignies
country: France
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city: Wattrelos
country: France
facility: Research Site
city: Yerres
country: France
facility: Research Site
city: Yffiniac
country: France
facility: Research Site
Study officials:
affiliation: Le Point Medical - Rond Point du Jour
name: Michel Farnier, MD
role: PRINCIPAL_INVESTIGATOR
References: