Evaluation of Atorvastatin Treatment on Carotid Plaque.

NCT ID: NCT00343655

Last Updated: 2021-02-18

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-08-31

Brief Summary

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The purpose of the study is to evaluate the effect of 18 months treatment with atorvastatin 80mg or atorvastatin 10mg on the carotid vessel plaque morphology, in particular, the effect on evident necrotic lipid rich core of the plaque in patients.

Detailed Description

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Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Atorvastatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with measurable carotid plaque with lipid and are eligible for statin therapy.

Exclusion Criteria

* Subjects at higher risk for cardiovascular disease with a screen LDL-cholesterol greater than 120 mg/dL,
* Subjects currently on high dose statin, and
* Subjects with contraindications for MRI or statin therapy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Boston, Massachusetts, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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A2581152

Identifier Type: -

Identifier Source: org_study_id

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