STELLAR-Rosuvastatin vs. Atorvastatin, Pravastatin, Simvastatin Across Dose Ranges

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: Pravastatin; Drug: Atorvastatin; Drug: Simvastatin; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00654537

D3560C00065

4522IL/0065

Details and patient eligibility

About

To compare the efficacy of various doses of rosuvastatin with atorvastatin, pravastatin & simvastatin in reducing levels of low density lipoprotein cholesterol in subjects with hypercholesterolaemia.

Enrollment: 5,625 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Discontinuation of all previous lipid lowering therapy.
• Fasting LDL-c levels of between 160mg/dl - 250 mg/dl at Visits 2 & 3 for subjects not on lipid lowering therapy at Visit 1.
• Other lipid parameters as specified in 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
• Abnormal laboratory parameters as defined in the protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5,625 participants in 4 patient groups

1

Experimental group

Description:

Rosuvastatin

Treatment:

Drug: Rosuvastatin

2

Active Comparator group

Description:

Atorvastatin

Treatment:

Drug: Atorvastatin

3

Active Comparator group

Description:

Pravastatin

Treatment:

Drug: Pravastatin

4

Active Comparator group

Description:

Simvastatin

Treatment:

Drug: Simvastatin