Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects

Hypercholesterolemia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654394
• Other study ID #: 4522IL/0044
• Secondary ID: D3560C00044
• Status: Completed
• Phase: Phase 3
• First received: April 3, 2008
• Last updated: March 13, 2009
• Start date: January 2000
• Est. completion date: August 2004

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the changes in the carotid artery when subjects receive high or low doses of rosuvastatin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carotid Artery Diseases
• Carotid Artery Stenosis
• Carotid Stenosis
• Constriction, Pathologic
• Hypercholesterolemia

Intervention

Drug:
• Rosuvastatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in carotid wall volume as measured by MRI scan		At 40 weeks and 104 weeks
Secondary	Safety: adverse events & abnormal laboratory markers		2 weekly for first 4 weeks then 4 weekly
Secondary	Other changes in the structure and composition of the carotid arterial wall as defined in the protocol.		At 40 weeks and 104 weeks