OLE Study to Evaluate Safety / Efficacy of ZD4522

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolaemia

Treatments: Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00654303

D3560C00034

4522IL/0034

Details and patient eligibility

About

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

Enrollment: 3,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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3,500 participants in 1 patient group

1

Experimental group

Description:

Rosuvastatin

Treatment:

Drug: Rosuvastatin