Rosuvastatin Versus Atorvastatin in the Treatment of Hypercholesterolaemia in African American Subjects(ARIES)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia; Dyslipidaemia

Treatments: Drug: Rosuvastatin; Drug: Atorvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00653744

4522US/0002

D3560L00022

Details and patient eligibility

About

The purpose of this study is to compare the effect of 6 weeks of treatment with Rosuvastatin with 6 weeks of treatment with Atorvastatin in African American subjects with hypercholesterolemia.

Enrollment: 1,700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fasting low density lipoprotein level as defined by the protocol.
• Self described African American race
• 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: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,700 participants in 2 patient groups

1

Experimental group

Description:

Rosuvastatin

Treatment:

Drug: Rosuvastatin

2

Active Comparator group

Description:

Atorvastatin

Treatment:

Drug: Atorvastatin