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Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects

Primary Purpose

Carotid Artery Stenosis, Hypercholesterolemia

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 Carotid Artery Stenosis focused on measuring Cholesterol, Carotid Artery Stenosis, Hypercholesterolemia, Rosuvastatin, Crestor

Eligibility Criteria

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

Inclusion Criteria:

  • Fasting blood low density lipoprotein cholesterol level as defined by the protocol
  • Diagnosed carotid arterial stenosis

Exclusion Criteria:

  • The use of lipid lowering drugs or dietary supplements after Visit 1.
  • Heavy or total occlusion of the carotid artery or recent stroke
  • Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    Outcomes

    Primary Outcome Measures

    Changes in carotid wall volume as measured by MRI scan

    Secondary Outcome Measures

    Safety: adverse events & abnormal laboratory markers
    Other changes in the structure and composition of the carotid arterial wall as defined in the protocol.

    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
    NCT00654394
    Brief Title
    Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects
    Official Title
    Randomized, Double-Blind, Multicenter, Trial to Assess the Effect of High & Low Doses of ZD4522 on Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects With Asymptomatic Carotid Stenosis After 24 Months of Dosing.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2000 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 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 examine the changes in the carotid artery when subjects receive high or low doses of rosuvastatin.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carotid Artery Stenosis, Hypercholesterolemia
    Keywords
    Cholesterol, Carotid Artery Stenosis, Hypercholesterolemia, Rosuvastatin, Crestor

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Rosuvastatin
    Other Intervention Name(s)
    Crestor
    Primary Outcome Measure Information:
    Title
    Changes in carotid wall volume as measured by MRI scan
    Time Frame
    At 40 weeks and 104 weeks
    Secondary Outcome Measure Information:
    Title
    Safety: adverse events & abnormal laboratory markers
    Time Frame
    2 weekly for first 4 weeks then 4 weekly
    Title
    Other changes in the structure and composition of the carotid arterial wall as defined in the protocol.
    Time Frame
    At 40 weeks and 104 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Fasting blood low density lipoprotein cholesterol level as defined by the protocol Diagnosed carotid arterial stenosis Exclusion Criteria: The use of lipid lowering drugs or dietary supplements after Visit 1. Heavy or total occlusion of the carotid artery or recent stroke Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tom Hatsukami
    Organizational Affiliation
    University of Washington, 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

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    Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects

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