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

This study has been completed.

First Received: March 26, 2008 Last Updated: March 13, 2009 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00653744

Purpose

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.

Condition	Intervention	Phase
Hypercholesterolemia Dyslipidaemia	Drug: Rosuvastatin Drug: Atorvastatin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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)

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Atorvastatin Atorvastatin calcium Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Low density lipoproteins cholesterol levels [ Time Frame: 6 weeks ]

Secondary Outcome Measures:

Other blood lipid level changes [ Time Frame: 6 weeks ]
Safety: adverse events & abnormal laboratory markers [ Time Frame: 6 weeks ]

Estimated Enrollment:	1700
Study Start Date:	March 2002
Study Completion Date:	March 2004

Arms	Assigned Interventions
1: Experimental Rosuvastatin	Drug: Rosuvastatin
2: Active Comparator Atorvastatin	Drug: Atorvastatin

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653744

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Keith Ferdinand	Heartbeats Life Centre, New Orleans, USA
Study Director:	Russell Esterline	AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca ( Elisabeth Björk )
Study ID Numbers:	4522US/0002, D3560L00022
Study First Received:	March 26, 2008
Last Updated:	March 13, 2009
ClinicalTrials.gov Identifier:	NCT00653744 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Cholesterol
low density lipoproteins
dyslipidaemia
Rosuvastatin

Crestor
Atorvastatin
Lipitor
African American

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions
Rosuvastatin
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010