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

Primary Purpose

Hypercholesteremia

Status
Completed
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Rosuvastatin
Atorvastatin
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesteremia focused on measuring high blood cholesterol levels

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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Outcomes

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.

Full Information

First Posted
October 13, 2005
Last Updated
November 18, 2010
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00239330
Brief Title
Direct Statin Comparison of LDL-C Values: an Evaluation of Rosuvastatin Therapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
February 2005 (Actual)
Study Completion Date
February 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesteremia
Keywords
high blood cholesterol levels

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
824 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
Title
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.
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy Vandenhoven, MD
Organizational Affiliation
AstraZeneca NV/SA
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Antwerpen
Country
Belgium
Facility Name
Research Site
City
Arlon
Country
Belgium
Facility Name
Research Site
City
Assebroek
Country
Belgium
Facility Name
Research Site
City
Ath
Country
Belgium
Facility Name
Research Site
City
Aye
Country
Belgium
Facility Name
Research Site
City
Bastogne
Country
Belgium
Facility Name
Research Site
City
Baudour
Country
Belgium
Facility Name
Research Site
City
Borgerhout
Country
Belgium
Facility Name
Research Site
City
Bornem
Country
Belgium
Facility Name
Research Site
City
Bouge
Country
Belgium
Facility Name
Research Site
City
Brugge
Country
Belgium
Facility Name
Research Site
City
Brussels
Country
Belgium
Facility Name
Research Site
City
Charleroi
Country
Belgium
Facility Name
Research Site
City
Dendermonde
Country
Belgium
Facility Name
Research Site
City
Frameries
Country
Belgium
Facility Name
Research Site
City
Gent
Country
Belgium
Facility Name
Research Site
City
Hasselt
Country
Belgium
Facility Name
Research Site
City
Havré
Country
Belgium
Facility Name
Research Site
City
Kortenberg
Country
Belgium
Facility Name
Research Site
City
Leuven
Country
Belgium
Facility Name
Research Site
City
Mol
Country
Belgium
Facility Name
Research Site
City
Namur
Country
Belgium
Facility Name
Research Site
City
Oostende
Country
Belgium
Facility Name
Research Site
City
Roeselare
Country
Belgium
Facility Name
Research Site
City
Schoten
Country
Belgium
Facility Name
Research Site
City
Sint-Agatha-Berchem
Country
Belgium

12. IPD Sharing Statement

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

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