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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00239330

Purpose

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.

Condition	Intervention	Phase
Hypercholesteremia	Drug: Rosuvastatin Drug: Atorvastatin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Atorvastatin Atorvastatin calcium Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 Measures:

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.

Estimated Enrollment:	824
Study Start Date:	June 2003
Study Completion Date:	February 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239330

Locations

Belgium
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
Sint-Agatha-Berchem, 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
Dendermonde, Belgium

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Guy Vandenhoven, MD

AstraZeneca NV/SA

More Information

No publications provided

Study ID Numbers:	D3560L00011, DISCOVERY
Study First Received:	October 13, 2005
Last Updated:	March 25, 2009
ClinicalTrials.gov Identifier:	NCT00239330 History of Changes
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Keywords provided by AstraZeneca:

high blood cholesterol levels

Study placed in the following topic categories:

Antimetabolites
Rosuvastatin
Metabolic Diseases
Hyperlipidemias
Antilipemic Agents
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Metabolic Disorder
Hypercholesterolemia
Atorvastatin
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions
Rosuvastatin
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on September 11, 2009