Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00654394

Enrollment

200

Registered

2008-04-08

Start date

2000-01-31

Completion date

2004-08-31

Last updated

2009-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Artery Stenosis, Hypercholesterolemia

Keywords

Cholesterol, Carotid Artery Stenosis, Hypercholesterolemia, Rosuvastatin, Crestor

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.

Interventions

DRUGRosuvastatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026