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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Dyslipidaemia

Treatments: Drug: Rosuvastatin; Behavioral: Maintenance of specific diet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00654602

4522IL/0091

D3560C00091

Details and patient eligibility

About

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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)