NCT00654394
Completed
Phase 3
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.
Overview
- Phase
- Phase 3
- Intervention
- Rosuvastatin
- Conditions
- Carotid Artery Stenosis
- Sponsor
- AstraZeneca
- Enrollment
- 200
- Primary Endpoint
- Changes in carotid wall volume as measured by MRI scan
- Status
- Completed
- Last Updated
- 17 years ago
Overview
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.
Investigators
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
- •Heavy or total occlusion of the carotid artery or recent stroke
- •Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse
Arms & Interventions
1
Intervention: Rosuvastatin
Outcomes
Primary Outcomes
Changes in carotid wall volume as measured by MRI scan
Time Frame: At 40 weeks and 104 weeks
Secondary Outcomes
- Safety: adverse events & abnormal laboratory markers(2 weekly for first 4 weeks then 4 weekly)
- Other changes in the structure and composition of the carotid arterial wall as defined in the protocol.(At 40 weeks and 104 weeks)
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