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This Study Uses Ultrasound to Determine Whether Atorvastatin or Pravastatin Effects the Progression of Coronary Plaque.

NCT ID: NCT00380939

Last Updated: 2006-12-04

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

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-04-30

Study Completion Date

2000-12-31

Brief Summary

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This study was designed to assess the effects on coronary artery plaque using aggressive lipid-lowering therapy versus moderate lipid-lowering therapy. A substudy will examine the effect of these treatments on brachial artery vasoactivity.

Detailed Description

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Conditions

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Coronary Arteriosclerosis

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

Pravastatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Angiographic evidence of coronary artery disease as defined by a lesion that has at least 20% reduction in luman diameter by visual (angiographic) estimation in any native coronary artery. LDL cholesterol equal to 125mg/dl - 210mg/dl.

Exclusion Criteria

* Patients who are anticipated to undergo coronary bypass surgery or cardiac transplantation during the course of the study. Known major hematologic, neoplastic, metabolic, gastrointestinal or endocrine dysfunction.
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Little Rock, Arkansas, United States

Site Status

Pfizer Investigational Site

Los Angeles, California, United States

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Pfizer Investigational Site

Los Angeles, California, United States

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San Diego, California, United States

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Denver, Colorado, United States

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BLUE Island, Florida, United States

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Gainesville, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Shawnee Mission, Kansas, United States

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Louisville, Kentucky, United States

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Auburn, Maine, United States

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Boston, Massachusetts, United States

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Kalamazoo, Michigan, United States

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Royal Oak, Michigan, United States

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Saint Clair, Michigan, United States

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Rochester, Minnesota, United States

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Albany, New York, United States

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New York, New York, United States

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Williamsville, New York, United States

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Chapel Hill, North Carolina, United States

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Greensboro, North Carolina, United States

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Greenville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cleveland, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Elryia, Ohio, United States

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Toledo, Ohio, United States

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Tulsa, Oklahoma, United States

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Allentown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Providence, Rhode Island, United States

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Providence, Rhode Island, United States

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San Antonio, Texas, United States

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Pfizer Investigational Site

Seattle, Washington, United States

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Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0981-400-314&StudyName=This+study+uses+ultrasound+to+determine+whether+atorvastatin+or+pravastatin+effects+the+progression+of+coronary+plaque%2E

To obtain contact information for a study center near you, click here.

Other Identifiers

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0981-400-314

Identifier Type: -

Identifier Source: org_study_id