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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Hypercholesteremia

Treatments: Drug: Rosuvastatin; Drug: Atorvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00239330

D3560L00011

DISCOVERY

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)