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
  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 3

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


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
Experimental: 1
Rosuvastatin
Drug: Rosuvastatin
Other Name: Crestor
Active Comparator: 2
Atorvastatin
Drug: Atorvastatin
Other Name: Lipitor

  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: Elisabeth Björk, AstraZeneca
ClinicalTrials.gov Identifier: NCT00653744     History of Changes
Other Study ID Numbers: 4522US/0002, D3560L00022
Study First Received: March 26, 2008
Last Updated: March 13, 2009
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:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014