Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects

Phase 3

Completed

• Conditions: Hypercholesterolemia; Carotid Artery Stenosis
• Interventions: Drug: Rosuvastatin

• Registration Number: NCT00654394
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-01
• Study Completion: 2004-08
• Study First Submitted: 2008-04-03
• Study First Submitted QC: 2008-04-03
• Study First Posted: 2008-04-08
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-13
• Last Update Posted: 2009-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Rosuvastatin	-

Primary Outcome Measures

Name	Time	Method
Changes in carotid wall volume as measured by MRI scan	At 40 weeks and 104 weeks

Secondary Outcome Measures

Name	Time	Method
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