Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Carotid Artery Stenosis Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

Other names: Crestor

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

Time frame: 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.

Time frame: At 40 weeks and 104 weeks

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Important dates

Study start: 2000
Study completion: 2004
First posted: Apr 8, 2008
Registry last updated: Mar 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed