NCT00239330

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 of therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
824

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2003

Geographic Reach
1 country

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
Last Updated

November 19, 2010

Status Verified

November 1, 2010

Enrollment Period

1.7 years

First QC Date

October 13, 2005

Last Update Submit

November 18, 2010

Conditions

Hypercholesteremia

Keywords

high blood cholesterol levels

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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.

Interventions

RosuvastatinDRUG
Also known as: Crestor
AtorvastatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia).
  • Serious or unstable medical condition
  • Statin contraindication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Research Site

Antwerp, Belgium

Location

Research Site

Arlon, Belgium

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Research Site

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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Research Site

Sint-Agatha-Berchem, Belgium

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Rosuvastatin CalciumAtorvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrrolesAzolesHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Guy Vandenhoven, MD

    AstraZeneca NV/SA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 17, 2005

Study Start

June 1, 2003

Primary Completion

February 1, 2005

Study Completion

February 1, 2005

Last Updated

November 19, 2010

Record last verified: 2010-11

Locations

BE(26)