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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypercholesterolemia; Dyslipidaemia

Intervention: Rosuvastatin (Drug); Atorvastatin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Keith Ferdinand, Principal Investigator, Affiliation: Heartbeats Life Centre, New Orleans, USA
Russell Esterline, Study Director, Affiliation: AstraZeneca

Summary

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.

Clinical Details

Official title: A 6-Week, Randomized, Open-Label, Comparative Study to Evaluate the Efficacy and Safety of Rosuvastatin Versus Atorvastatin in the Treatment of Hypercholesterolaemia in African American Subjects. (ARIES)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Low density lipoproteins cholesterol levels

Secondary outcome:

Other blood lipid level changes

Safety: adverse events & abnormal laboratory markers

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Additional Information

Starting date: March 2002
Last updated: March 13, 2009

Page last updated: August 23, 2015

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