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Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00654394
Recruitment Status : Completed
First Posted : April 8, 2008
Last Update Posted : March 16, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Carotid Artery Stenosis Hypercholesterolemia Drug: Rosuvastatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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.
Study Start Date : January 2000
Actual Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: Rosuvastatin
Other Name: Crestor

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

Secondary Outcome Measures :
  1. Safety: adverse events & abnormal laboratory markers [ Time Frame: 2 weekly for first 4 weeks then 4 weekly ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00654394

Sponsors and Collaborators
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Principal Investigator: Tom Hatsukami University of Washington, USA
Study Director: Russell Esterline AstraZeneca

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Responsible Party: Elisabeth Björk, AstraZeneca Identifier: NCT00654394    
Other Study ID Numbers: 4522IL/0044
First Posted: April 8, 2008    Key Record Dates
Last Update Posted: March 16, 2009
Last Verified: March 2009
Keywords provided by AstraZeneca:
Carotid Artery Stenosis
Additional relevant MeSH terms:
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Carotid Stenosis
Constriction, Pathologic
Plaque, Atherosclerotic
Pathological Conditions, Anatomical
Lipid Metabolism Disorders
Metabolic Diseases
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors