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STELLAR-Rosuvastatin vs. Atorvastatin, Pravastatin, Simvastatin Across Dose Ranges (STELLAR)

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rosuvastatin
Atorvastatin
Pravastatin
Simvastatin
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, hypercholesterolemia, low density lipoproteins

Eligibility Criteria

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

Inclusion Criteria:

  • Discontinuation of all previous lipid lowering therapy.
  • Fasting LDL-c levels of between 160mg/dl - 250 mg/dl at Visits 2 & 3 for subjects not on lipid lowering therapy at Visit 1.
  • Other lipid parameters as specified in 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
  • Abnormal laboratory parameters as defined in the protocol.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    1

    2

    3

    4

    Arm Description

    Rosuvastatin

    Atorvastatin

    Pravastatin

    Simvastatin

    Outcomes

    Primary Outcome Measures

    Percentage change in low density lipoprotein cholesterol.

    Secondary Outcome Measures

    Percentage change in other lipid parameters as defined by the protocol
    Safety evaluation

    Full Information

    First Posted
    April 3, 2008
    Last Updated
    March 13, 2009
    Sponsor
    AstraZeneca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00654537
    Brief Title
    STELLAR-Rosuvastatin vs. Atorvastatin, Pravastatin, Simvastatin Across Dose Ranges
    Acronym
    STELLAR
    Official Title
    A 6 Week Open Label, Dose Comparison Study to Evaluate the Safety and Efficacy of Rosuvastatin Versus Atorvastatin, Pravastatin, and Simvastatin in Subjects With Hypercholesterolemia.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2001 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    AstraZeneca

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To compare the efficacy of various doses of rosuvastatin with atorvastatin, pravastatin & simvastatin in reducing levels of low density lipoprotein cholesterol in subjects with hypercholesterolaemia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypercholesterolemia
    Keywords
    Cholesterol, hypercholesterolemia, low density lipoproteins

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    5625 (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
    Arm Title
    3
    Arm Type
    Active Comparator
    Arm Description
    Pravastatin
    Arm Title
    4
    Arm Type
    Active Comparator
    Arm Description
    Simvastatin
    Intervention Type
    Drug
    Intervention Name(s)
    Rosuvastatin
    Other Intervention Name(s)
    Crestor
    Intervention Type
    Drug
    Intervention Name(s)
    Atorvastatin
    Other Intervention Name(s)
    Lipitor
    Intervention Type
    Drug
    Intervention Name(s)
    Pravastatin
    Other Intervention Name(s)
    Lipostat
    Intervention Type
    Drug
    Intervention Name(s)
    Simvastatin
    Other Intervention Name(s)
    Zocor
    Primary Outcome Measure Information:
    Title
    Percentage change in low density lipoprotein cholesterol.
    Time Frame
    4 & 6 weeks
    Secondary Outcome Measure Information:
    Title
    Percentage change in other lipid parameters as defined by the protocol
    Time Frame
    6 weeks
    Title
    Safety evaluation
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Discontinuation of all previous lipid lowering therapy. Fasting LDL-c levels of between 160mg/dl - 250 mg/dl at Visits 2 & 3 for subjects not on lipid lowering therapy at Visit 1. Other lipid parameters as specified in 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 Abnormal laboratory parameters as defined in the protocol.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eleanor Miller, MD
    Organizational Affiliation
    AstraZeneca
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Russell Esterline
    Organizational Affiliation
    AstraZeneca
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    STELLAR-Rosuvastatin vs. Atorvastatin, Pravastatin, Simvastatin Across Dose Ranges

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