Evaluation of Crestor® (Rosuvastatin) in Daily Practice

Completed

• Conditions: Hypercholesterolemia

• Registration Number: NCT00837083
• Lead Sponsor: AstraZeneca

Brief Summary

This open label, non-interventional study is to show the efficacy of Crestor (rosuvastatin) in reduction of LDL-cholesterol and cardiovascular risk parameters in patients with hypercholesterolemia. Effectiveness is to be evaluated using the difference in LDL cholesterol level between the first and the second visit after 12 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study Completion: 2007-10
• Status Verified: 2009-02
• Study First Submitted: 2009-02-04
• Study First Submitted QC: 2009-02-04
• Study First Posted: 2009-02-05
• Last Update Submitted: 2009-02-05
• Last Update Posted: 2009-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 602

Inclusion Criteria

• a patient with hypercholesterolemia who has been prescribed Crestoraccording to physician's judgement, irrespective of the inclusion in the study.
• no treatment with any statin in the last 3 months

Exclusion Criteria

• hypersensitivity to rosuvastatin or any other ingredient of Crestor
• active liver disease, severe renal insufficiency
• myopathy or predisposing risk factors for myopathy/ rhabdomyolysis
• woman of child-bearing potential and not using appropriate contraceptive measures, pregnancy or lactation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
LDL-cholesterol reduction	12 weeks

Secondary Outcome Measures

Name	Time	Method
achievement of target levels of total cholesterol and LDL-cholesterol	12 weeks
patient compliance	12 weeks
change in coronary risk	12 weeks