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

March 26, 2008
March 13, 2009
March 2002
Not Provided
Low density lipoproteins cholesterol levels [ Time Frame: 6 weeks ]
Same as current
Complete list of historical versions of study NCT00653744 on ClinicalTrials.gov Archive Site
  • Other blood lipid level changes [ Time Frame: 6 weeks ]
  • Safety: adverse events & abnormal laboratory markers [ Time Frame: 6 weeks ]
Same as current
Not Provided
Not Provided
 
Rosuvastatin Versus Atorvastatin in the Treatment of Hypercholesterolaemia in African American Subjects(ARIES)
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypercholesterolemia
  • Dyslipidaemia
  • Drug: Rosuvastatin
    Other Name: Crestor
  • Drug: Atorvastatin
    Other Name: Lipitor
  • Experimental: 1
    Rosuvastatin
    Intervention: Drug: Rosuvastatin
  • Active Comparator: 2
    Atorvastatin
    Intervention: Drug: Atorvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1700
March 2004
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00653744
4522US/0002, D3560L00022
No
Elisabeth Björk, AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Keith Ferdinand Heartbeats Life Centre, New Orleans, USA
Study Director: Russell Esterline AstraZeneca
AstraZeneca
March 2009

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