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

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00653744

First received: March 26, 2008

Last updated: March 13, 2009

Last verified: March 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

March 26, 2008

Last Updated Date

March 13, 2009

Start Date ^ICMJE

March 2002

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00653744 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Hypercholesterolemia
Dyslipidaemia

Intervention ^ICMJE

Drug: Rosuvastatin
Other Name: Crestor
Drug: Atorvastatin
Other Name: Lipitor

Study Arm (s)

Experimental: 1
Rosuvastatin

Intervention: Drug: Rosuvastatin
Active Comparator: 2
Atorvastatin

Intervention: Drug: Atorvastatin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

1700

Completion Date

March 2004

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00653744

Other Study ID Numbers ^ICMJE

4522US/0002, D3560L00022

Has Data Monitoring Committee

Responsible Party

Elisabeth Björk, AstraZeneca

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

AstraZeneca

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top