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

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Atorvastatin; Atorvastatin Calcium; Pravastatin; Rosuvastatin Calcium

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)