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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.
 
ClinicalTrials.gov Identifier: NCT00654394
Recruitment Status : Completed
First Posted : April 8, 2008
Last Update Posted : March 16, 2009
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE April 3, 2008
First Posted Date  ICMJE April 8, 2008
Last Update Posted Date March 16, 2009
Study Start Date  ICMJE January 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2008)
Changes in carotid wall volume as measured by MRI scan [ Time Frame: At 40 weeks and 104 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00654394 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Carotid Artery Stenosis
  • Hypercholesterolemia
Intervention  ICMJE Drug: Rosuvastatin
Other Name: Crestor
Study Arms  ICMJE Experimental: 1
Intervention: Drug: Rosuvastatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 3, 2008)
200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00654394
Other Study ID Numbers  ICMJE 4522IL/0044
D3560C00044
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elisabeth Björk, AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tom Hatsukami University of Washington, USA
Study Director: Russell Esterline AstraZeneca
PRS Account AstraZeneca
Verification Date March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP