Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects

NCT ID: NCT00654394

Last Updated: 2009-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2004-08-31

Brief Summary

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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

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Conditions

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Carotid Artery Stenosis Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

Interventions

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Rosuvastatin

Intervention Type DRUG

Other Intervention Names

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Crestor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Tom Hatsukami

Role: PRINCIPAL_INVESTIGATOR

University of Washington, USA

Russell Esterline

Role: STUDY_DIRECTOR

AstraZeneca

References

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Clezar CN, Flumignan CD, Cassola N, Nakano LC, Trevisani VF, Flumignan RL. Pharmacological interventions for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2023 Aug 4;8(8):CD013573. doi: 10.1002/14651858.CD013573.pub2.

Reference Type DERIVED
PMID: 37565307 (View on PubMed)

Other Identifiers

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D3560C00044

Identifier Type: -

Identifier Source: secondary_id

4522IL/0044

Identifier Type: -

Identifier Source: org_study_id

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