- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00396110
Evaluation of the Efficacy of Rosuvastatin in Daily Practice (TARGET)
November 3, 2006 updated by: AstraZeneca
In this study the effect of the switch to rosuvastatin from another statin (fluvastatin, pravastatin, simvastatin, atorvastatin) was evaluated in high-risk patients with and without evident CHD and LDL-C ≥ 3.2 mmol/l.
This was done in a large observational study (TARGET) representing daily practice.
Primary end points analysis was the percentage of patients reaching the target of LDL-C < 3.2 mmol/l.
Secondary outcomes were the changes of LDL-C, HDL-C, TC, Triglycerides (TG) and TC/HDL-C-ratio from baseline.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment
3889
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 to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- High-risk patients with and without evident CHD who had LDL-C > 3.2 mmol/l and were treated at that moment with HMG-CoA-reductase inhibitor apart from rosuvastatin.
- Patients were aged >18 years and <70 years (men) and < 75 years (women).
Exclusion Criteria:
- Treatment with atorvastatin 40 or 80 mg or simvastatin 80 mg
- Patients familiar with muscular pain, myopathy or liver function disorders (inclusive elevation of serum transaminases) and/or contra-indications for treatment with rosuvastatin
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
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Ingrid van Geel, MD, AstraZeneca
- Study Chair: Ingeborg Vosjan, MD, AstraZeneca
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
February 1, 2003
Study Registration Dates
First Submitted
November 3, 2006
First Submitted That Met QC Criteria
November 3, 2006
First Posted (Estimate)
November 6, 2006
Study Record Updates
Last Update Posted (Estimate)
November 6, 2006
Last Update Submitted That Met QC Criteria
November 3, 2006
Last Verified
February 1, 2003
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25V06
- TARGET
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.
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