IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Fredrickson Type IIa & Type IIb Dyslipidaemia

Treatments: Drug: Simvastatin; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00654446

4522IL/0099

Details and patient eligibility

About

The purpose of this study is to assess the effects on the kidney of rosuvastatin and simvastatin in subjects with Fredrickson Type IIa & Type IIb Dyslipidaemia

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 creatine levels above the limits defined in the protocol or +4 proteinuria during dietary lead in period.
• Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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442 participants in 2 patient groups

1

Experimental group

Description:

Rosuvastatin

Treatment:

Drug: Rosuvastatin

2

Active Comparator group

Description:

Simvastatin

Treatment:

Drug: Simvastatin