Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects

March 13, 2009 updated by: AstraZeneca

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Rosuvastatin
Other Names:
  • Crestor

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety: adverse events & abnormal laboratory markers
Time Frame: 2 weekly for first 4 weeks then 4 weekly
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
At 40 weeks and 104 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Russell Esterline, AstraZeneca
  • Principal Investigator: Tom Hatsukami, University of Washington, USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

April 3, 2008

First Submitted That Met QC Criteria

April 3, 2008

First Posted (Estimate)

April 8, 2008

Study Record Updates

Last Update Posted (Estimate)

March 16, 2009

Last Update Submitted That Met QC Criteria

March 13, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4522IL/0044
  • D3560C00044

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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