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OLE Study to Evaluate Safety / Efficacy of ZD4522

Primary Purpose

Hypercholesterolaemia

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

About this trial

This is an interventional treatment trial for Hypercholesterolaemia focused on measuring Cholesterol, Hypercholesterolaemia, Statins

Eligibility Criteria

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

Inclusion Criteria:

  • Completion of previous Crestor study as listed in the protocol.

Exclusion Criteria:

  • Pregnant or breast feeding women, or not using appropriate contraception.
  • Abnormal lab values as listed in the protocol.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    Rosuvastatin

    Outcomes

    Primary Outcome Measures

    Safety, as determined by adverse events, laboratory data, physical examination and ECG.

    Secondary Outcome Measures

    Success in achieving goals for Cholesterol levels

    Full Information

    First Posted
    April 2, 2008
    Last Updated
    March 13, 2009
    Sponsor
    AstraZeneca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00654303
    Brief Title
    OLE Study to Evaluate Safety / Efficacy of ZD4522
    Official Title
    ZD4522 Long Term Extension Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1999 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    February 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    AstraZeneca

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to assess the long term safety of Crestor.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypercholesterolaemia
    Keywords
    Cholesterol, Hypercholesterolaemia, Statins

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    3500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Rosuvastatin
    Intervention Type
    Drug
    Intervention Name(s)
    Rosuvastatin
    Other Intervention Name(s)
    Crestor
    Primary Outcome Measure Information:
    Title
    Safety, as determined by adverse events, laboratory data, physical examination and ECG.
    Time Frame
    12 weekly
    Secondary Outcome Measure Information:
    Title
    Success in achieving goals for Cholesterol levels
    Time Frame
    12 weekly

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Completion of previous Crestor study as listed in the protocol. Exclusion Criteria: Pregnant or breast feeding women, or not using appropriate contraception. Abnormal lab values as listed in the protocol.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elinor Miller, MD
    Organizational Affiliation
    AstraZeneca
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    OLE Study to Evaluate Safety / Efficacy of ZD4522

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