Clinical trial NCT00239330: Direct Statin Comparison of LDL-C Values: an Evaluation of Rosuvastatin Therapy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesteremia
Keywords: high blood cholesterol levels
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-17
Enrollment: 824
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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 outcomes:
measure: 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.
measure: 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.
measure: 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.
measure: 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.
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Research Site
city: Arlon
country: Belgium
facility: Research Site
city: Assebroek
country: Belgium
facility: Research Site
city: Ath
country: Belgium
facility: Research Site
city: Aye
country: Belgium
facility: Research Site
city: Bastogne
country: Belgium
facility: Research Site
city: Baudour
country: Belgium
facility: Research Site
city: Borgerhout
country: Belgium
facility: Research Site
city: Bornem
country: Belgium
facility: Research Site
city: Bouge
country: Belgium
facility: Research Site
city: Brugge
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Charleroi
country: Belgium
facility: Research Site
city: Dendermonde
country: Belgium
facility: Research Site
city: Frameries
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Hasselt
country: Belgium
facility: Research Site
city: Havré
country: Belgium
facility: Research Site
city: Kortenberg
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Mol
country: Belgium
facility: Research Site
city: Namur
country: Belgium
facility: Research Site
city: Oostende
country: Belgium
facility: Research Site
city: Roeselare
country: Belgium
facility: Research Site
city: Schoten
country: Belgium
facility: Research Site
city: Sint-Agatha-Berchem
country: Belgium
facility: Research Site
Study officials:
affiliation: AstraZeneca NV/SA
name: Guy Vandenhoven, MD
role: STUDY_DIRECTOR
References: