Status:
COMPLETED
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
Lead Sponsor:
AstraZeneca
Conditions:
Type IIa and IIb Hypercholesterolaemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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. T...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
668 Patients enrolled
Trial Details
Trial ID
NCT00631189
Start Date
October 1 2007
End Date
October 1 2008
Last Update
November 26 2013
Active Locations (170)
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1
Research Site
Aix-en-Provence, France
2
Research Site
Allaire, France
3
Research Site
Amiens, France
4
Research Site
Ancerville, France