OLE Study to Evaluate Safety / Efficacy of ZD4522

Phase 3

Completed

• Conditions: Hypercholesterolaemia
• Interventions: Drug: Rosuvastatin

• Registration Number: NCT00654303
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to assess the long term safety of Crestor.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-08
• Study Completion: 2005-02
• Study First Submitted: 2008-04-02
• Study First Submitted QC: 2008-04-02
• Study First Posted: 2008-04-07
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-13
• Last Update Posted: 2009-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3500

Inclusion Criteria

• Completion of previous Crestor study as listed in the protocol.

Exclusion Criteria

• Pregnant or breast feeding women, or not using appropriate contraception.
• Abnormal lab values as listed in the protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Rosuvastatin	Rosuvastatin

Primary Outcome Measures

Name	Time	Method
Safety, as determined by adverse events, laboratory data, physical examination and ECG.	12 weekly

Secondary Outcome Measures

Name	Time	Method
Success in achieving goals for Cholesterol levels	12 weekly