Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects - Full Text View

Purpose

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

Condition	Intervention	Phase
Carotid Artery Stenosis Hypercholesterolemia	Drug: Rosuvastatin	Phase III

Genetics Home Reference related topics:

hypercholesterolemia

MedlinePlus related topics:

Cholesterol

ChemIDplus related topics:

Rosuvastatin Rosuvastatin calcium Cholest-5-en-3-ol (3beta)-

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

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.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Changes in carotid wall volume as measured by MRI scan [ Time Frame: At 40 weeks and 104 weeks ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	200
Study Start Date:	January 2000
Study Completion Date:	December 2004
Primary Completion Date:	August 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Rosuvastatin

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 1.
Heavy or total occlusion of the carotid artery or recent stroke
Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654394

Sponsors and Collaborators

AstraZeneca

Investigators


Principal Investigator:	Tom Hatsukami	University of Washington, USA

Study Director:	Russell Esterline	AstraZeneca

More Information

Responsible Party:	AstraZeneca ( Elisabeth Björk )
Study ID Numbers:	4522IL/0044, D3560C00044
First Received:	April 3, 2008
Last Updated:	April 3, 2008
ClinicalTrials.gov Identifier:	NCT00654394
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Cholesterol

Carotid Artery Stenosis

Hypercholesterolemia

Rosuvastatin

Crestor

Study placed in the following topic categories:

Arterial Occlusive Diseases

Pathological Conditions, Anatomical

Metabolic Diseases

Hyperlipidemias

Disease Progression

Vascular Diseases

Central Nervous System Diseases

Constriction, Pathologic

Brain Diseases

Cerebrovascular Disorders

Carotid Stenosis

Rosuvastatin

Metabolic disorder

Carotid Artery Diseases

Hypercholesterolemia

Dyslipidemias

Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Antilipemic Agents

Nervous System Diseases

Enzyme Inhibitors

Cardiovascular Diseases

Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00654394