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Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00654394
First received: April 3, 2008
Last updated: March 13, 2009
Last verified: March 2009
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

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: August 2004
Arms Assigned Interventions
Experimental: 1 Drug: Rosuvastatin
Other Name: Crestor

  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

No publications provided

Responsible Party: Elisabeth Björk, AstraZeneca
ClinicalTrials.gov Identifier: NCT00654394     History of Changes
Other Study ID Numbers: 4522IL/0044, D3560C00044
Study First Received: April 3, 2008
Last Updated: March 13, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Cholesterol
Carotid Artery Stenosis
Hypercholesterolemia
Rosuvastatin
Crestor

Additional relevant MeSH terms:
Carotid Stenosis
Constriction, Pathologic
Hypercholesterolemia
Plaque, Atherosclerotic
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Hyperlipidemias
 Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013