Efficacy Evaluation of Rosuvastatin 5 mg vs Pravastatin 40 mg and Atorvastatin 10 mg in Hypercholesterolaemia Subjects

Condition(s) targeted: Type IIa and IIb Hypercholesterolaemia

Intervention: Rosuvastatin (Drug); Pravastatin (Drug); Atorvastatin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Michel Farnier, MD, Principal Investigator, Affiliation: Le Point Medical - Rond Point du Jour

Overall contact:
AstraZeneca France Clinical Study Information, Phone: 33 1 41 29 40 00

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.

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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The primary objective of this study is to compare the variation (as a percentage of baseline values) of the LDL-C level after treatment with: Rosuvastatin versus Pravastatin and Rosuvastatin versus Atorvastatin.

Secondary outcome: Compare the variation (as a percentage of baseline values) of total cholesterol, HDL-C and triglyceride levels, of ApoB/ApoA1 ratio, of CRP and phospholipase A2 levels after treatment with: Rosuvastatin vs. Pravastatin and Rosuvastatin vs. Atorvastatin

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

AstraZeneca France Clinical Study Information, Phone: 33 1 41 29 40 00

Research Site, AIX EN PROVENCE, France; Recruiting

Research Site, ALLAIRE, France; Recruiting

Research Site, AMIENS, France; Recruiting

Research Site, ANCERVILLE, France; Recruiting

Research Site, ANGERS, France; Recruiting

Research Site, ANNECY, France; Recruiting

Research Site, ANZIN, France; Recruiting

Research Site, ARLES, France; Recruiting

Research Site, ARTHEZ DE BEARN, France; Recruiting

Research Site, ASPACH LE BAS, France; Recruiting

Research Site, AUBAGNE, France; Recruiting

Research Site, AUCHEL, France; Recruiting

Research Site, BAILLEUL, France; Recruiting

Research Site, BALMA, France; Recruiting

Research Site, BEAUCAIRE, France; Recruiting

Research Site, BELFORT, France; Recruiting

Research Site, BERSEE, France; Recruiting

Research Site, BEZENET, France; Recruiting

Research Site, BEZIERS, France; Recruiting

Research Site, BIARRITZ, France; Recruiting

Research Site, BLOIS, France; Recruiting

Research Site, BOERSCH, France; Recruiting

Research Site, BONDUES, France; Recruiting

Research Site, BONDY, France; Recruiting

Research Site, BORDEAUX, France; Recruiting

Research Site, BRIGNOUD, France; Recruiting

Research Site, BRUAY LA BUISSIERE, France; Recruiting

Research Site, BRUGES, France; Recruiting

Research Site, CABANAC ET VILLAGRAINS, France; Recruiting

Research Site, CADAUJAC, France; Recruiting

Research Site, CAEN, France; Recruiting

Research Site, CANNES LA BOCCA, France; Recruiting

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Research Site, CAYLUS, France; Recruiting

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Research Site, FARGUES ST HILAIRE, France; Recruiting

Research Site, FOLEMBRAY, France; Recruiting

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Research Site, FRANCONVILLE LA GARENNE, France; Recruiting

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Research Site, GAMBSHEIM, France; Recruiting

Research Site, GRADIGNAN, France; Recruiting

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Starting date: October 2007
Ending date: November 2008
Last updated: February 28, 2008