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

AstraZeneca668 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

668

Conditions

Type IIa and IIb Hypercholesterolaemia

Interventions

RosuvastatinDRUG

5mg oral

PravastatinDRUG

40mg oral

AtorvastatinDRUG

10mg oral

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (170)

Outcomes

Primary Outcomes

Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks

To compare the percentages of LDL-C level variation. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data

Time frame: Change from baseline and after 8 weeks of treatment

Secondary Outcomes

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

Not done. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data

Time frame: Not done

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

Time frame: Not done

Compare the Percentage of Total Cholesterol Variation From Baseline and After 8 Weeks of Treatment

To compare the percentage of total cholesterol variation taking baseline value as a reference. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data

Time frame: from baseline and after 8 weeks of treatment

Data from ClinicalTrials.gov

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Research Site

Aix-en-Provence, France

Research Site

Allaire, France

Research Site

Amiens, France

Research Site

Ancerville, France

Research Site

Angers, France

Research Site

Annecy, France

Research Site

Anzin, France

Research Site

Arles, France

Research Site

Arthez-de-Béarn, France

Research Site

Aspach-le-Bas, France

...and 160 more locations

Compare the Percentage of HDL-C (High Density Lipoprotein Cholesterol) Variation From Baseline and After 8 Weeks of Treatment

Compare the percentage of HDL-C (High Density Lipoprotein Cholesterol) variation taking baseline value as a reference and after 8 weeks of treatment. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data

Time frame: After 8 weeks of treatment

Compare the Percentage of Variation From Baseline Triglycerides Values and After 8 Weeks

To compare the percentage of variation from baseline triglycerides values and after 8 weeks. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data

Time frame: Baseline and after 8 weeks of treatment

Compare the Percentage of Variation From Baseline Apolipoprotein B/Apolipoprotein A1 Ratio and After 8 Weeks of Treatment

To Compare the percentage of variation from baseline Apolipoprotein B/Apolipoprotein A1 ratio and after 8 weeks of treatment. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data

Time frame: baseline and after 8 weeks of treatment

Compare the Percentage of Variation of C-reactive Protein (CRP)

To compare the percentage of variation of C-reactive protein (CRP) taking baseline values as reference. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data

Time frame: baseline and after 8 weeks of treatment

Compare the Percentage of Variation of Phospholipase A2 (PLA2)

To Compare the percentage of variation of phospholipase A2 (PLA2) taking baseline value as a reference. As the recruitment target was not reached at the date initially planned, and view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data

Time frame: from baseline and after 8 weeks of treatment

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

To Compare numbers of patients achieving the LDL-C goal according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP). As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data. The percentage of patients achieving the NCEP-ATP III LDL-C goal. ATP III is categorized into 3 risk categories:(1) established CHD and CHD risk equivalents(2) multiple risk factors(3) zero to one (0-1) risk factor

Time frame: from baseline and after 8 weeks of treatment

Compare the Numbers of Patients Achieving the LDL-C Goal According to the European Atherosclerosis Society (EAS) Guidelines for the Management of Dyslipidaemic Patients

To Evaluate Clinical and Laboratory Safety

Serious Adverse Event and Adverse Event reported throughout the study

Time frame: duration of study