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

November 18, 2010 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Hypercholesteremia

Intervention / Treatment

Study Type

Interventional

Enrollment

824

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Belgium
- - 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, Belgium
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

Study Director: Guy Vandenhoven, MD, AstraZeneca NV/SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

February 1, 2005

Study Completion (Actual)

February 1, 2005

Study Registration Dates

First Submitted

October 13, 2005

First Submitted That Met QC Criteria

October 13, 2005

First Posted (Estimate)

October 17, 2005

Study Record Updates

Last Update Posted (Estimate)

November 19, 2010

Last Update Submitted That Met QC Criteria

November 18, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

high blood cholesterol levels

Additional Relevant MeSH Terms

Other Study ID Numbers

D3560L00011
DISCOVERY

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.