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

Primary Purpose

Hypercholesterolemia, Dyslipidaemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rosuvastatin
Atorvastatin
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring Cholesterol, low density lipoproteins, dyslipidaemia, Rosuvastatin, Crestor, Atorvastatin, Lipitor, African American

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Rosuvastatin

    Atorvastatin

    Outcomes

    Primary Outcome Measures

    Low density lipoproteins cholesterol levels

    Secondary Outcome Measures

    Other blood lipid level changes
    Safety: adverse events & abnormal laboratory markers

    Full Information

    First Posted
    March 26, 2008
    Last Updated
    March 13, 2009
    Sponsor
    AstraZeneca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00653744
    Brief Title
    Rosuvastatin Versus Atorvastatin in the Treatment of Hypercholesterolaemia in African American Subjects(ARIES)
    Acronym
    ARIES
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    AstraZeneca

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypercholesterolemia, Dyslipidaemia
    Keywords
    Cholesterol, low density lipoproteins, dyslipidaemia, Rosuvastatin, Crestor, Atorvastatin, Lipitor, African American

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1700 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Rosuvastatin
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Atorvastatin
    Intervention Type
    Drug
    Intervention Name(s)
    Rosuvastatin
    Other Intervention Name(s)
    Crestor
    Intervention Type
    Drug
    Intervention Name(s)
    Atorvastatin
    Other Intervention Name(s)
    Lipitor
    Primary Outcome Measure Information:
    Title
    Low density lipoproteins cholesterol levels
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Other blood lipid level changes
    Time Frame
    6 weeks
    Title
    Safety: adverse events & abnormal laboratory markers
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Keith Ferdinand
    Organizational Affiliation
    Heartbeats Life Centre, New Orleans, USA
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Russell Esterline
    Organizational Affiliation
    AstraZeneca
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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