Back to resultsProgression 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
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
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
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
Learn more about this trial
Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects
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