Direct Statin Comparison of LDL-C Values: an Evaluation of Rosuvastatin Therapy
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesteremia
Intervention: Rosuvastatin (Drug); Atorvastatin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Guy Vandenhoven, MD, Study Director, Affiliation: AstraZeneca NV/SA
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.
Clinical Details
Official title: An Open-Label, Randomised, Multi-Centre, Phase IIIb, Parallel Group Study to Compare the Efficacy and Safety of Rosuvastatin and Atorvastatin in Subjects With Type IIa and IIb Hypercholesterolaemia
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
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
Locations and Contacts
Research Site, Brussels, Belgium
Research Site, Antwerpen, Belgium
Research Site, Arlon, Belgium
Research Site, Assebroek, Belgium
Research Site, Ath, Belgium
Research Site, Aye, Belgium
Research Site, Bastogne, Belgium
Research Site, Baudour, Belgium
Research Site, Borgerhout, Belgium
Research Site, Bornem, Belgium
Research Site, Bouge, Belgium
Research Site, Brugge, Belgium
Research Site, Charleroi, Belgium
Research Site, Dendermonde, Belgium
Research Site, Frameries, Belgium
Research Site, Gent, Belgium
Research Site, Hasselt, Belgium
Research Site, Havré, Belgium
Research Site, Kortenberg, Belgium
Research Site, Leuven, Belgium
Research Site, Mol, Belgium
Research Site, Namur, Belgium
Research Site, Oostende, Belgium
Research Site, Roeselare, Belgium
Research Site, Schoten, Belgium
Research Site, Sint-Agatha-Berchem, Belgium
Additional Information
Starting date: June 2003
Last updated: April 18, 2006
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