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Comparing the Efficacy and Safety of Rosuvastatin With Atorvastatin and Simvastatin (SOLAR) (SOLAR)

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rosuvastatin
Simvastatin
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, Zocor, simvastatin

Eligibility Criteria

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

Inclusion Criteria:

  • Member of managed care plan for hypercholesterolemia
  • Fasting blood lipid levels as defined by the protocol
  • Diagnosis of coronary heart disease, diabetes, or atherosclerotic disease, or presence of multiple risk factors giving high risk of coronary heart disease

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 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    1

    2

    3

    Arm Description

    Rosuvastatin

    Simvastatin

    Atorvastatin

    Outcomes

    Primary Outcome Measures

    Percentage of subjects who achieve low density lipoprotein cholesterol goals while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin.

    Secondary Outcome Measures

    Percentage changes in other blood lipid levels while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin
    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
    NCT00654173
    Brief Title
    Comparing the Efficacy and Safety of Rosuvastatin With Atorvastatin and Simvastatin (SOLAR)
    Acronym
    SOLAR
    Official Title
    A 12-Week, Randomized, Open-Label, 3 Arm Parallel Group, Multicenter, Phase IIIb Study Comparing the Efficacy and Safety of Rosuvastatin With Atorvastatin and Simvastatin Achieving NCEP ATP III LDL-C Goals in High Risk Subjects With Hypercholesterolaemia in the Managed Care Setting.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 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 efficacy and safety of rosuvastatin with simvastatin and atorvastatin 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, low density lipoproteins, dyslipidaemia, Rosuvastatin, Crestor, Atorvastatin, Lipitor, Zocor, simvastatin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    4444 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Rosuvastatin
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Simvastatin
    Arm Title
    3
    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)
    Simvastatin
    Other Intervention Name(s)
    Zocor
    Intervention Type
    Drug
    Intervention Name(s)
    Atorvastatin
    Other Intervention Name(s)
    Lipitor
    Primary Outcome Measure Information:
    Title
    Percentage of subjects who achieve low density lipoprotein cholesterol goals while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin.
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Percentage changes in other blood lipid levels while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin
    Time Frame
    6 & 12 weeks
    Title
    Safety: adverse events & abnormal laboratory markers
    Time Frame
    6 & 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Member of managed care plan for hypercholesterolemia Fasting blood lipid levels as defined by the protocol Diagnosis of coronary heart disease, diabetes, or atherosclerotic disease, or presence of multiple risk factors giving high risk of coronary heart disease 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
    Alex Gold, MD
    Organizational Affiliation
    AstraZeneca
    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

    Comparing the Efficacy and Safety of Rosuvastatin With Atorvastatin and Simvastatin (SOLAR)

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