Status:
COMPLETED
Direct Statin Comparison of LDL-C Values: an Evaluation of Rosuvastatin Therapy
Lead Sponsor:
AstraZeneca
Conditions:
Hypercholesteremia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
February 1 2005
Estimated Enrollment :
824 Patients enrolled
Trial Details
Trial ID
NCT00239330
Start Date
June 1 2003
End Date
February 1 2005
Last Update
November 19 2010
Active Locations (26)
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1
Research Site
Antwerp, Belgium
2
Research Site
Arlon, Belgium
3
Research Site
Assebroek, Belgium
4
Research Site
Ath, Belgium