OLE Study to Evaluate Safety / Efficacy of ZD4522

ZD4522 Long Term Extension Trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00654303

Enrollment

3500

Registered

2008-04-07

Start date

1999-08-31

Completion date

2005-02-28

Last updated

2009-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolaemia

Keywords

Cholesterol, Hypercholesterolaemia, Statins

Brief summary

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

Interventions

DRUGRosuvastatin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Success in achieving goals for Cholesterol levels	12 weekly

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026