48-wk Open Label Phase IIIb to Evaluate Efficacy and Safety

Phase 3

Completed

• Conditions: Dyslipidaemia

• Registration Number: NCT00654602
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to assess the efficacy and safety of rosuvastatin in reducing low density lipoprotein cholesterol levels to internationally recognised goals in subjects with dyslipidaemia.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-02
• Study Completion: 2004-11
• Study First Submitted: 2008-04-03
• Study First Submitted QC: 2008-04-03
• Study First Posted: 2008-04-08
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-27
• Last Update Posted: 2009-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Fasting low density lipoprotein level as defined by the protocol.
• Fasting triglyceride level as defined by the protocol.

Exclusion Criteria

• The use of lipid lowering drugs or dietary supplements after Visit 1.
• Active arterial disease eg Unstable angina, or recent arterial surgery.
• Blood lipid levels above the limits defined in the protocol.
• Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Reduction in low density lipoprotein cholesterol levels	12 weeks

Secondary Outcome Measures

Name	Time	Method
Reduction in low density lipoprotein cholesterol levels	24 & 48 weeks
Safety: adverse events & abnormal laboratory markers	4 weekly until week 12 then 12 weekly thereafter.
Maintenance of lowered low density lipoprotein cholesterol level	Between week 12-48