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

Hypercholesteremia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00239330
• Other study ID #: D3560L00011
• Secondary ID: DISCOVERY
• Status: Completed
• Phase: Phase 3
• First received: October 13, 2005
• Last updated: November 18, 2010
• Start date: June 2003
• Est. completion date: February 2005

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 824
• Est. completion date: February 2005
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesteremia
• Hypercholesterolemia

Intervention

Drug:
• Rosuvastatin

• Atorvastatin

Locations

Country	Name	City	State
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	Brussels
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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.