Direct Statin Comparison of LDL-C Values: an Evaluation of Rosuvastatin Therapy

Phase 3

Completed

• Conditions: Hypercholesteremia

• Registration Number: NCT00239330
• Lead Sponsor: AstraZeneca

Brief Summary

The primary objective of the study is to compare the efficacy of rosuvastatin 10 mg with atorvastatin 10 mg by assessment of the percentage of subjects who reach EAS LDL-C target goals after 12 weeks of therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2005-02
• Study Completion: 2005-02
• Study First Submitted: 2005-10-13
• Study First Submitted QC: 2005-10-13
• Study First Posted: 2005-10-17
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-18
• Last Update Posted: 2010-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 824

Inclusion Criteria

• Male or female subjects, age > 18 years
• Primary hypercholesterolaemia with CV risk > 20% (as defined in European Guidelines ) and/or type II diabetes and/or a history of CHD or other established atherosclerotic disease. Subjects may be lipid-lowering therapy naïve or have been treated for min. 4 weeks with a 'start' dose of any lipid-lowering therapy, which was ineffective.
• Naïve subjects must have completed 12-weeks dietary counselling before this visit.

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Exclusion Criteria

• Known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia).
• Documented secondary hypercholesterolaemia of any cause other than named in inclusion criteria 3.
• Serious or unstable medical condition
• Statin contraindication

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary objective of the study is to compare the efficacy of rosuvastatin 10 mg with atorvastatin 10 mg by assessment of the percentage of subjects who reach EAS LDL-C target goals after 12 weeks of therapy.

Secondary Outcome Measures

Name	Time	Method
To compare the efficacy of rosuvastatin 10 mg with atorvastatin 10 mg by assessment of the percentage of subjects who reach EAS TC treatment goal after 12 weeks of therapy.
To compare the percentage change in LDL-C, TC, HDL-C and TG from pre-dose rosuvastatin 10 mg / atorvastatin 10 mg (week 0) and at 12 weeks. This will be performed separately for the switched and the naïve subjects.
To compare the efficacy of rosuvastatin 10 mg with atorvastatin 10 mg in modifying lipids (Non-HDL-C, TC/HDL-C, LDL-C/ HDL-C, non-HDL-C/HDL-C) at week 12. This will be performed separately for the switched and the naïve subjects.
To compare rosuvastatin 10 mg with atorvastatin 10 mg after 12 & 24 weeks of treatment with respect to the incidence & severity of adverse events & abnormal laboratory values.

Trial Locations

Locations (1)

Research Site; 🇧🇪 Sint-Agatha-Berchem, Belgium