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

NCT ID: NCT00239330

Last Updated: 2010-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

824 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2005-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Hypercholesteremia

Keywords

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high blood cholesterol levels

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Rosuvastatin

Intervention Type DRUG

Atorvastatin

Intervention Type DRUG

Other Intervention Names

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Crestor

Eligibility Criteria

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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.

* Serious or unstable medical condition
* Statin contraindication

Exclusion Criteria

* Known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Guy Vandenhoven, MD

Role: STUDY_DIRECTOR

AstraZeneca NV/SA

Locations

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Research Site

Antwerp, , Belgium

Site Status

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Arlon, , Belgium

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Assebroek, , Belgium

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Ath, , Belgium

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Aye, , Belgium

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Bastogne, , Belgium

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Baudour, , Belgium

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Borgerhout, , Belgium

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Bornem, , Belgium

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Bouge, , Belgium

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Bruges, , Belgium

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Brussels, , Belgium

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Charleroi, , Belgium

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Dendermonde, , Belgium

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Frameries, , Belgium

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Ghent, , Belgium

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Hasselt, , Belgium

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Havré, , Belgium

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Kortenberg, , Belgium

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Leuven, , Belgium

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Mol, , Belgium

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Namur, , Belgium

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Ostend, , Belgium

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Roeselare, , Belgium

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Schoten, , Belgium

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Sint-Agatha-Berchem, , Belgium

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Countries

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Belgium

Other Identifiers

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DISCOVERY

Identifier Type: -

Identifier Source: secondary_id

D3560L00011

Identifier Type: -

Identifier Source: org_study_id