Elevated High-sensitivity C-Reactive Protein (hsCRP)Phase 3NCT00239681

JUPITER - Crestor 20mg Versus Placebo in Prevention of Cardiovascular (CV) Events

A Phase 3 study testing Rosuvastatin in people with Elevated High-sensitivity C-Reactive Protein (hsCRP), run by AstraZeneca at 856 sites in 27 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to determine the safety and effectiveness of long-term therapy with rosuvastatin compared with a placebo, and to evaluate whether treatment with rosuvastatin might be effective in reducing the risk of major cardiovascular events. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Elevated High-sensitivity C-Reactive Protein (hsCRP)
What is being tested?: Rosuvastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 17,802 participants
Where: 856 sitesin 27 countries
Study dates: Feb 2003to Sep 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men 50 years or older, women 60 years or older
Low to normal levels of low density lipoprotein (LDL) cholesterol (< 130mg/dL)
Elevated levels of C-Reactive Protein (CRP) > 2.0 mg/L

Who cannot join

History of cardiovascular or cerebrovascular events
Active liver disease
Diabetes mellitus
Uncontrolled hypertension or hypothyroidism
History of certain malignancies
Chronic inflammatory conditions
History of alcohol or drug abuse

Trial locations and contacts

856 sites in 27 countries.

Country

City, postcode or hospital

725 sites in 27 countries

United States300 sites

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Akron, Ohio
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Albany, New York
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Albuquerque, New Mexico
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Alexandria, Virginia
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Alhambra, California
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Altoona, Pennsylvania
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Anaconda, Montana
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Apopka, Florida
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Arlington, Texas
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Arlington, Virginia
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Asheville, North Carolina
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Athens, Ohio
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Atlanta, Georgia
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Auburn, Maine
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Augusta, Georgia
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Aurora, Colorado
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Aurora, Illinois
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Austin, Texas
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Avon, Connecticut
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Avon, Indiana
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Ayer, Massachusetts
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Azusa, California
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Baltimore, Maryland
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Bangor, Maine
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Baton Rouge, Louisiana
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Beaver, Pennsylvania
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Bellbrook, Ohio
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Beloit, Wisconsin
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Berkeley, California
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Berkley, Michigan
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Beverly Hills, California
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Beverly Hills, Florida
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Binghamton, New York
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Birmingham, Alabama
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Bloomfield, New Jersey
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Bloomsburg, Pennsylvania
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Blue Ridge, Georgia
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Boston, Massachusetts
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Bountiful, Utah
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Bowmansville, New York
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Brick, New Jersey
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Bristol, Connecticut
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Bristol, Tennessee
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Bronxville, New York
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Brooklyn, New York
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Broomall, Pennsylvania
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Brunswick, Georgia
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Buffalo, New York
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Burien, Washington
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Burke, Virginia
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Burlingame, California
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Burlington, Massachusetts
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Burlington, North Carolina
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Burlington, Vermont
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Butte, Montana
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Calera, Alabama
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Camillus, New York
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Camp Hill, Pennsylvania
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Canal Fulton, Ohio
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Cape Coral, Florida
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Carmichael, California
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Carrollton, Texas
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Cary, North Carolina
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Centerville, Ohio
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Champaign, Illinois
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Chapel Hill, North Carolina
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Charleston, South Carolina
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Charleston, West Virginia
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Charlotte, North Carolina
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Charlotte Hall, Maryland
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Charlottesville, Virginia
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Chaska, Minnesota
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Chattanooga, Tennessee
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Cherry Hill, New Jersey
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Chesterfield, Missouri
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Chesterland, Ohio
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Chicago, Illinois
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Cincinnati, Ohio
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Clarksville, Tennessee
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Clearwater, Florida
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Colleyville, Texas
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Colorado Springs, Colorado
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Columbiana, Alabama
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Columbus, Georgia
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Columbus, Ohio
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Concord, California
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Connellsville, Pennsylvania
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Conyers, Georgia
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Cooper City, Florida
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Corpus Christi, Texas
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Corvallis, Oregon
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Covington, Louisiana
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Cranston, Rhode Island
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Crystal River, Florida
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Culver City, California
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Dallas, Oregon
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Dallas, Texas
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Daly City, California
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Davie, Florida
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Dayton, Ohio
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Dearborn, Michigan
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Decatur, Alabama
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Decatur, Georgia
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Deerfield Beach, Florida
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Delray Beach, Florida
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Denver, Colorado
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Des Moines, Iowa
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Downingtown, Pennsylvania
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Dubuque, Iowa
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Duluth, Minnesota
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Durham, North Carolina
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East Bridgewater, Massachusetts
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East Islip, New York
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East Syracuse, New York
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El Paso, Texas
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Elizabeth, New Jersey
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Englewood Cliffs, New Jersey
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Erie, Pennsylvania
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Eugene, Oregon
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Evansville, Indiana
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Evansville, Kentucky
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Everett, Washington
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Excelsior Springs, Missouri
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Fargo, North Dakota
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Fayetteville, Arkansas
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Fayetteville, Georgia
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Fayetteville, New York
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Fayetteville, North Carolina
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Fayetteville, Tennessee
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Feasterville, Pennsylvania
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Fleetwood, Pennsylvania
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Folsom, California
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Foothill Ranch, California
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Fort Collins, Colorado
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Fort Lauderdale, Florida
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Fort Worth, Texas
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Fountain Valley, California
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Fresno, California
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Friendswood, Texas
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Gainesville, Florida
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Garden Grove, California
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Germantown, Tennessee
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Gig Harbor, Washington
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Glen Burnie, Maryland
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Golden, Colorado
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Grand Island, Nebraska
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Grand Rapids, Michigan
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Granger, Indiana
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Grapevine, Texas
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Graysville, Alabama
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Green Bay, Wisconsin
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Greenville, South Carolina
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Greer, South Carolina
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Gulfport, Mississippi
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Gurnee, Illinois
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Guthrie, Oklahoma
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Hagerstown, Maryland
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Haleyville, Alabama
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Hampton, South Carolina
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Hampton, Virginia
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Harleysville, Pennsylvania
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Harrisburg, Pennsylvania
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Hartford, Connecticut
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Hartselle, Alabama
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Haverhill, Massachusetts
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Hayes, Virginia
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Henderson, Nevada
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Hendersonville, Tennessee
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Highlands Ranch, Colorado
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Hot Springs, Arkansas
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Houma, Louisiana
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Houston, Texas
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Huntsville, Alabama
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Idaho Falls, Idaho
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Indianapolis, Indiana
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Inglewood, California
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Iowa City, Iowa
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Irvine, California
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Irving, Texas
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Jackson, Mississippi
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Jacksonville, Florida
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Jefferson City, Missouri
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Jefferson City, Tennessee
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Jeffersonville, Indiana
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Jersey Shore, Pennsylvania
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Johnson City, Tennessee
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Johnston, Rhode Island
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Kalispell, Montana
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Kansas City, Missouri
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King of Prussia, Pennsylvania
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La Jolla, California
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La Mesa, California
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Lake Charles, Louisiana
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Lake Jackson, Texas
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Lake Oswego, Oregon
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Lake Road, Illinois
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Lake Success, New York
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Lakeland, Florida
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Languna Niguel, California
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Lansdale, Pennsylvania
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Lansdowne, Pennsylvania
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Largo, Florida
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Las Vegas, Nevada
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Leavenworth, Kansas
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Lenoir, North Carolina
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Lewisburg, Pennsylvania
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Lewisburg, West Virginia
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Lewistown, Pennsylvania
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Lexington, Kentucky
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Lexington, North Carolina
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Little Rock, Arkansas
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Littleton, Colorado
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Livonia, Michigan
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Lock Haven, Pennsylvania
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Long Beach, California
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Los Alamos, New Mexico
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Los Angeles, California
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Los Gatos, California
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Louisville, Kentucky
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Loveland, Colorado
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Lubbock, Texas
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Madison, Wisconsin
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Mamaroneck, New York
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Manchester, Missouri
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Mansfield, Ohio
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Margate, Florida
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Marrero, Louisiana
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Massillon, Ohio
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Maumee, Ohio
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McMurray, Pennsylvania
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Medford, Oregon
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Melrose Park, Illinois
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Melrose Park, Pennsylvania
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Memphis, Tennessee
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Menomonee Falls, Wisconsin
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Meridian, Idaho
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Mesa, Arizona
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Mexico, Missouri
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Miami, Florida
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Milwaukee, Wisconsin
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Milwaukie, Oregon
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Minneapolis, Minnesota
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Mission Hills, California
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Mission Viejo, California
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Missoula, Montana
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Mobile, Alabama
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Modesto, California
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Moncks Corner, South Carolina
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Montgomery, Alabama
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Morristown, New Jersey
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Morristown, Tennessee
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Morton, Illinois
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Mount Vernon, New York
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Mt. Pleasant, South Carolina
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Munster, Indiana
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Muscle Shoals, Alabama
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Muskogee, Oklahoma
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Nashua, New Hampshire
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Nashville, Tennessee
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Natick, Massachusetts
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Nephi, Utah
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New Braunfels, Texas
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New Hartford, New York
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New Hyde Park, New York
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New Orleans, Louisiana
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New York, New York
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Newark, Delaware
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Newark, New Jersey
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Newburgh, Indiana
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Newport Beach, California
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Newton, Massachusetts
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Niagara Falls, New York
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Norfolk, Virginia
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Norristown, Pennsylvania
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North Miami Beach, Florida
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North Richland Hills, Texas
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Northbrunswick, New Jersey
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Norwalk, California
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O'Fallon, Illinois
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Oklahoma City, Oklahoma
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Olathe, Kansas
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Olive Branch, Mississippi
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Olympia, Washington
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Omaha, Nebraska
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Orange, California
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Orangeburg, South Carolina
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Orangevale, California
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Orland Park, Illinois
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Orlando, Florida
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Ormond Beach, Florida
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Overland Park, Kansas
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Pahrump, Nevada
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Palm Desert, California
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Palm Harbor, Florida
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Pasadena, California
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Passaic, New Jersey
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Pawtucket, Rhode Island
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Pensacola, Florida
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Petoskey, Michigan
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Pharr, Texas

Other trials in United States

Canada85 sites

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Amherst Nova Scotia, Nova Scotia
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Antigonish Nova Scotia, Nova Scotia
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Bay Roberts, Newfoundland and Labrador
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Bolton, Ontario
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Brampton, Ontario
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Burlington, Ontario
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Calgary, Alberta
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Cambridge, Ontario
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Carbonear, Newfoundland and Labrador
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Charlottetown, Prince Edward Island
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Chicoutimi, Quebec
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Chilliwack, British Columbia
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Conception Bay South, Newfoundland and Labrador
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Coquitlam, British Columbia
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Corunna, Ontario
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Courcelette, Quebec
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Courtice, Ontario
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Digby, Nova Scotia
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Drummonville, Quebec
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Edmonton, Alberta
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Etobicoke, Ontario
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Exeter, Ontario
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Gatineau, Quebec
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Granby, Quebec
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Grand Bay-Westfield, New Brunswick
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Greater Sudbury, Ontario
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Greenfield Park, Quebec
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Halifax, Nova Scotia
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Hamilton, Ontario
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Holyrood, Newfoundland and Labrador
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Ingersoll, Ontario
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Kelowna, British Columbia
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Kingston, Ontario
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Langley, British Columbia
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LaSalle, Quebec
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Laval, Quebec
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London, Ontario
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Longueuil, Quebec
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Markham, Ontario
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Moncton, New Brunswick
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Montreal, Quebec
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Mount Pearl, Newfoundland and Labrador
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Nackawic, New Brunswick
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New Westminster, British Columbia
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Newmarket, Ontario
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Niagara Falls, Ontario
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North Bay, Ontario
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North York, Ontario
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Orléans, Ontario
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Oshawa, Ontario
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Ottawa, Ontario
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Penticton, British Columbia
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Perth, Ontario
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Peterborough, Ontario
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Pointe-Claire, Quebec
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Portage la Prairie, Manitoba
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Québec, Quebec
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Regina, Saskatchewan
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Renfrew, Ontario
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Saint Catherines, Ontario
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Saint John, New Brunswick
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Saint-Georges, Quebec
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Saint-Marc-des-Carrieres, Quebec
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Sainte-Catherine, Quebec
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Sainte-Julie, Quebec
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Sarnia, Ontario
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Saskatoon, Saskatchewan
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Scarborough Village, Ontario
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Sherbrooke, Quebec
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Smith Falls, Ontario
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St. John's, Newfoundland and Labrador
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Stirling, Ontario
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Surrey, British Columbia
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Thornhill, Ontario
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Thunder Bay, Ontario
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Tillsonburg, Ontario
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Toronto, Ontario
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Trois-Rivières, Quebec
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Vanier, Quebec
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Victoria, British Columbia
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Windsor, Nova Scotia
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Windsor, Ontario
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Winnipeg, Manitoba
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Woodstock, New Brunswick
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Woodstock, Ontario

Other trials in Canada

Belgium74 sites

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Alsemberg, Belgium
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Ans
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Anthée, Belgium
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Auvelais, Belgium
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Baisy-Thy, Belgium
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Bertrix, Belgium
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Betekom, Belgium
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Boechout, Belgium
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Braine-l'Alleud, Belgium
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Brussels
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Burdinne, Belgium
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Cerexhe-Heuseux, Belgium
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Champion, Belgium
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Chênée, Belgium
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Comines, Belgium
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De Pinte
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Deurne (antwerpen), Belgium
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Dour, Belgium
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Ekeren
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Embourg, Belgium
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Evergem
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Genk, Belgium
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Genly, Belgium
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Gozée, Belgium
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Grivegnée, Belgium
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Halen, Belgium
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Hasselt, Belgium
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Heurne, Belgium
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Heusden, Belgium
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Hove, Belgium
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Kessel-Lo, Belgium
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Kraainem, Belgium
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Landen, Belgium
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Lauwe
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Leopoldsburg, Belgium
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Leuven, Belgium
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Libin, Belgium
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Linkebeek, Belgium
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Lommel, Belgium
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Marchienne-au-Pont, Belgium
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Marchovelette, Belgium
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Massemen
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Mechelen-aan-de-Maas, Belgium
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Melsbroek, Belgium
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Moerkerke
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Mont-sur-Marchienne, Belgium
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Moorsel, Belgium
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Mouscron, Belgium
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Natoye, Belgium
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Oostham, Belgium
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Opgrimbie (maasmechelen), Belgium
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Oudenaarde
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Paal, Belgium
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Puurs, Belgium
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Ronquières, Belgium
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Ronse, Belgium
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Rumst, Belgium
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Saint-Médard, Belgium
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Schoonaarde
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Schuiferskapelle
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Sint-Gillis-Waas, Belgium
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Steenokkerzeel, Belgium
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Tavier, Belgium
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Tessenderlo, Belgium
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Thuin, Belgium
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Tielt
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Tremelo, Belgium
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Trois-Ponts, Belgium
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Turnhout, Belgium
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Vilvoorde, Belgium
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Waremme, Belgium
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Weerde, Belgium
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Wezembeek-Oppem, Belgium
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Zoersel, Belgium

Other trials in Belgium

Poland42 sites

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Aleksandrów Łódzki
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Bydgoszcz
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Bytom
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Chodzież
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Chorzów
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Gdansk
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Gliwice
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Jelcz Laskowice
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Karpacz
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Katowice
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Koluszki
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Krakow
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Linia
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Lodz
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Lublin
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Nowogard
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Oława
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Olsztyn
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Opalenica
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Opole
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Ostrów Wielkopolski
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Piekary Śląskie
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Poznan
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Puławy
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Radom
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Radziejów
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Rybnik
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Sieradz
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Skierniewice
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Słupca
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Sobótka
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Sopot
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Szczecin
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Tarnów
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Torun
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Trzcianka
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Turek
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Wąbrzeźno
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Warsaw
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Wejherowo
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Wroclaw
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Zabrze

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Norway32 sites

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Bekkestua
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Bergen
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Bøverbru
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Elverum
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Flatåsen
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Fredrikstad
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Halden
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Heimdal
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Kristiansand
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Laksevåg
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Lena
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Lierskogen
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Løvenstad
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Lysaker
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Moelv
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Moss
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Oslo
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Østerås
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Paradis
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Rådal
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Randaberg
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Skedsmokorset
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Ski
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Skiptvet
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Snaroya
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Sogndal
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Spikkestad
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Stavanger
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Strømmen
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Svelvik
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Trollåsen
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Trondheim

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United Kingdom29 sites

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Airdrie, Scotland
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Annan, Dumfries and Galloway
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Barrhead
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Bellshill
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Birmingham
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Blantyre, Lanarkshire
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Cambuslang
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Cardiff
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Chorley
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Cumbernauld
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Glasgow, Scotland
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Gourock
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Greenock
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Hamilton, Lanarkshire
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Helensburgh
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Kirkintilloch
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Liverpool
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Lockerbie
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Manchester
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New Stevenson
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Paisley, Renfrewshire
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Reading, Berkshire
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Renfrew
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Stranraer
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Strathaven, Lanarkshire
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Strathblane
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Thornhill
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Wishaw, Lanarkshire
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Wolverhampton

Other trials in United Kingdom

South Africa19 sites

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Athlone, Cape Town
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Benoni
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Claremont, Cape Province
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Durban, KwaZulu-Natal
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eMkhomazi, KwaZulu-Natal
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Florida Park, Gauteng
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Halfway House, South Africa
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Hillcrest, Pretoria
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Johannesburg, South Africa
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Korsten, Port Elizabeth
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Lakeview, Retreat
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Lenasia, Gauteng
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Morningside Manor, Morningside
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Pretoria, Gauteng
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Rustenburg
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Somerset West
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Vanderbijlpark
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Witbank, Gauteng
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Worcester, South Africa

Other trials in South Africa

Netherlands17 sites

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Alkmaar
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Amersfoort
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Amsterdam
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Breda
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Deventer
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Eindhoven
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Gouda
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Groningen
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Hoorn
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Leiden
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Nijmegen
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Rotterdam
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The Hague
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Tilburg
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Utrecht
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Velp
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Zoetermeer

Other trials in Netherlands

Brazil14 sites

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Belo Horizonte, Minas Gerais
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Botucatu, São Paulo
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Campinas
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Fortaleza, Ceará
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Goiagoianiania, Goiás
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Maceió, Alagoas
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Passo Fundo, Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul
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Rio de Janeiro, Rio de Janeiro
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S.j.rio Preto, São Paulo
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Salvador, Estado de Bahia
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Santos, São Paulo
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São José do Rio Preto, São Paulo
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São Paulo, São Paulo

Other trials in Brazil

Germany14 sites

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Berlin
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Bochum
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Chemnitz
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Dortmund
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Dresden
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Frankfurt
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Görlitz
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Hamburg
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Künzing
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Leipzig
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Magdeburg
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Nuremberg
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Ulm
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Witten

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Russia12 sites

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Kemerovo
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Krasnoyarsk
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Moscow
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Novosibirsk
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Saint Petersburg
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Saratov
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Tolyatti
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Tomsk
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Tyumen
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Voronezh
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Yaroslavl
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Yekaterinburg

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Venezuela12 sites

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Barinas, Barinas
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Barquisimeto, Lara
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Caracas
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Ciudad Bolívar, Bolívar
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Latrinidad Caracas, Municipio Baruta
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Maracaibo, Zulia
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Maracay, Municipio Girardot, Aragua
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Mérida, Mérida
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Porlamar, Nueva Esparta
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Puerto Ordaz and San Felix, Bolívar
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Punto Fijo, Estado Falcon, Venezuela
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Valencia, Carabobo

Other trials in Venezuela

Israel11 sites

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Ashkelon Shore
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Beer Yakov
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Haifa
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Holon
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Jerusalem
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Kfar Saba
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Kiryat Hadassah, Jerusalem
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Safed
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Tel Aviv
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Tel HaShomer
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Zrifin

Other trials in Israel

Argentina10 sites

Research Site
Capital Federal, Buenos Aires
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Córdoba, Cordoba - Argentina
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Pilar, Buenos Aires
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Quilmes, Buenos Aires - Argentina
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Ramos Mejía, Buenos Aires Argentina
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Rosario, Santa Fe- Argentina
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Salta, Salta Province
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San Isidro, Buenos Aires- Argentina
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San Miguel de Tucumán, Tucuman / Argentina
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San Miguel de Tucumán, Tucuman-argentina

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Bulgaria8 sites

Research Site
Dimitrovgrad
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Haskovo
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Pleven
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Plovdiv
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Rousse
Research Site
Sofia
Research Site
Varna
Research Site
Veliko Tarnovo

Other trials in Bulgaria

Colombia8 sites

Research Site
Barranquilla, Atlántico
Research Site
Bogotá, Colombia
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Bucaramanga, Santander Department
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About this study

Official title: A Randomized, Double-Blind, Placebo Controlled, Multicenter, Phase 3 Study of Rosuvastatin (CRESTOR®) 20 mg in the Prevention of Cardiovascular Events Among Subjects With Low Levels of Low Density Lipoprotein(LDL) Cholesterol & Elevated Levels of C-Reactive Protein

Read the detailed description

AstraZeneca announced it has decided to stop the CRESTOR JUPITER clinical study early based on a recommendation from an Independent Data Monitoring Board and the JUPITER Steering Committee, which met on March 29, 2008. The study will be stopped early because there is unequivocal evidence of a reduction in cardiovascular morbidity and mortality amongst patients who received CRESTOR when compared to placebo.

Conditions: Elevated High-sensitivity C-Reactive Protein (hsCRP)
Being tested: Rosuvastatin, Placebo
Keywords: Primary prevention, Cardiovascular disease, Statin therapy, C-reactive protein
Medical subject headings: Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RosuvastatinDrug
Also called Crestor
Oral
PlaceboOther
Oral

Study groups in NCT00239681
Study group	Role	What they receive
Rosuvastatin	Experimental	Rosuvastatin 20 mg once daily Receives: Drug: Rosuvastatin
Placebo	Placebo comparator	Placebo once daily Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Major Cardiac Event (Cardiovascular Death, Stroke, Myocardial Infarction, Hospitalization Due to Unstable Angina or Arterial Revascularization)
Days from randomization to the first of CV death, stroke, MI, hospitalization for unstable angina or arterial revascularization. If no event, censoring occurs at earliest of termination date or efficacy cut-off date of 30 Mar 2008. Events were adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean
Measured: up to 5 years

Secondary outcomes (5)

Time to Death Due to Any Cause
Days from randomization to death. If no death then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Kaplan-Meier estimate of the mean
Measured: up to 5 years
Time to Non-cardiovascular Death
Days from randomization to death from a non-cardiovascular cause. If no event, then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Events were adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean
Measured: up to 5 years
Time to Development of Diabetes Mellitus
Days from randomization until development of diabetes. If no diabetes was developed censoring occurred at termination date. Kaplan-Meier estimate of the mean
Measured: up to 5 years
Time to Venous Thromboembolic Event
Time from randomization to the first venous thromboembolic event. Kaplan-Meier estimate of the mean
Measured: up to 5 years
Time to Bone Fracture
Days from randomization until bone fracture. If no event, then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Kaplan-Meier estimate of the mean
Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2003Sep 2008

First posted17 Oct 2005 (estimated)
Study startFeb 2003
Primary completionSep 2008
Study completionSep 2008

Why it stopped: See detailed description for reason.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (32)Papers the sponsor has linked to this study.
Other trials for Elevated High-sensitivity C-Reactive Protein (hsCRP)Studies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 17,802 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00239681
Sponsor's protocol ID: D3560L00030
Other IDs: Jupiter, 4522US/0011
Status last verified: Feb 2014
First submitted: 13 Oct 2005
Last updated: 24 Mar 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Hoshi RA, Alotaibi M, Liu Y, Watrous JD, Ridker PM, Glynn RJ, Serhan CN, Luttmann-Gibson H, Moorthy MV, Jain M, Demler OV, Mora S. One-Year Effects of High-Intensity Statin on Bioactive Lipids: Findings From the JUPITER Trial. Arterioscler Thromb Vasc Biol. 2024 Jul;44(7):e196-e206. doi: 10.1161/ATVBAHA.124.321058. Epub 2024 Jun 6.
PubMed 38841856
Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.
PubMed 38018702
Ajala ON, Demler OV, Liu Y, Farukhi Z, Adelman SJ, Collins HL, Ridker PM, Rader DJ, Glynn RJ, Mora S. Anti-Inflammatory HDL Function, Incident Cardiovascular Events, and Mortality: A Secondary Analysis of the JUPITER Randomized Clinical Trial. J Am Heart Assoc. 2020 Sep;9(17):e016507. doi: 10.1161/JAHA.119.016507. Epub 2020 Aug 15.
PubMed 32799709
Akinkuolie AO, Lawler PR, Chu AY, Caulfield M, Mu J, Ding B, Nyberg F, Glynn RJ, Ridker PM, Hurt-Camejo E, Chasman DI, Mora S. Group IIA Secretory Phospholipase A2, Vascular Inflammation, and Incident Cardiovascular Disease. Arterioscler Thromb Vasc Biol. 2019 Jun;39(6):1182-1190. doi: 10.1161/ATVBAHA.118.311894.
PubMed 31070471
Dagenais GR, Jung H, Lonn E, Bogaty PM, Dehghan M, Held C, Avezum A, Jansky P, Keltai M, Leiter LA, Lopez-Jaramillo P, Toff WD, Bosch J, Yusuf S. Effects of Lipid-Lowering and Antihypertensive Treatments in Addition to Healthy Lifestyles in Primary Prevention: An Analysis of the HOPE-3 Trial. J Am Heart Assoc. 2018 Jul 22;7(15):e008918. doi: 10.1161/JAHA.118.008918.
PubMed 30033433
Khera AV, Demler OV, Adelman SJ, Collins HL, Glynn RJ, Ridker PM, Rader DJ, Mora S. Cholesterol Efflux Capacity, High-Density Lipoprotein Particle Number, and Incident Cardiovascular Events: An Analysis From the JUPITER Trial (Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin). Circulation. 2017 Jun 20;135(25):2494-2504. doi: 10.1161/CIRCULATIONAHA.116.025678. Epub 2017 Apr 27.
PubMed 28450350
Akinkuolie AO, Glynn RJ, Padmanabhan L, Ridker PM, Mora S. Circulating N-Linked Glycoprotein Side-Chain Biomarker, Rosuvastatin Therapy, and Incident Cardiovascular Disease: An Analysis From the JUPITER Trial. J Am Heart Assoc. 2016 Jul 13;5(7):e003822. doi: 10.1161/JAHA.116.003822.
PubMed 27413042
Dugani SB, Akinkuolie AO, Paynter N, Glynn RJ, Ridker PM, Mora S. Association of Lipoproteins, Insulin Resistance, and Rosuvastatin With Incident Type 2 Diabetes Mellitus : Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2016 May 1;1(2):136-45. doi: 10.1001/jamacardio.2016.0096.
PubMed 27347563
Lawler PR, Akinkuolie AO, Chandler PD, Moorthy MV, Vandenburgh MJ, Schaumberg DA, Lee IM, Glynn RJ, Ridker PM, Buring JE, Mora S. Circulating N-Linked Glycoprotein Acetyls and Longitudinal Mortality Risk. Circ Res. 2016 Apr 1;118(7):1106-15. doi: 10.1161/CIRCRESAHA.115.308078. Epub 2016 Mar 7.
PubMed 26951635
Mora S, Caulfield MP, Wohlgemuth J, Chen Z, Superko HR, Rowland CM, Glynn RJ, Ridker PM, Krauss RM. Atherogenic Lipoprotein Subfractions Determined by Ion Mobility and First Cardiovascular Events After Random Allocation to High-Intensity Statin or Placebo: The Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) Trial. Circulation. 2015 Dec 8;132(23):2220-9. doi: 10.1161/CIRCULATIONAHA.115.016857. Epub 2015 Sep 25.
PubMed 26408274
Chu AY, Giulianini F, Barratt BJ, Ding B, Nyberg F, Mora S, Ridker PM, Chasman DI. Differential Genetic Effects on Statin-Induced Changes Across Low-Density Lipoprotein-Related Measures. Circ Cardiovasc Genet. 2015 Oct;8(5):688-95. doi: 10.1161/CIRCGENETICS.114.000962. Epub 2015 Aug 13.
PubMed 26273092
Everett BM, Zeller T, Glynn RJ, Ridker PM, Blankenberg S. High-sensitivity cardiac troponin I and B-type natriuretic Peptide as predictors of vascular events in primary prevention: impact of statin therapy. Circulation. 2015 May 26;131(21):1851-60. doi: 10.1161/CIRCULATIONAHA.114.014522. Epub 2015 Mar 30.
PubMed 25825410
Everett BM, Mora S, Glynn RJ, MacFadyen J, Ridker PM. Safety profile of subjects treated to very low low-density lipoprotein cholesterol levels (<30 mg/dl) with rosuvastatin 20 mg daily (from JUPITER). Am J Cardiol. 2014 Dec 1;114(11):1682-9. doi: 10.1016/j.amjcard.2014.08.041. Epub 2014 Sep 16.
PubMed 25439449
Pena JM, Aspberg S, MacFadyen J, Glynn RJ, Solomon DH, Ridker PM. Statin therapy and risk of fracture: results from the JUPITER randomized clinical trial. JAMA Intern Med. 2015 Feb;175(2):171-7. doi: 10.1001/jamainternmed.2014.6388.
PubMed 25437881
Khera AV, Everett BM, Caulfield MP, Hantash FM, Wohlgemuth J, Ridker PM, Mora S. Lipoprotein(a) concentrations, rosuvastatin therapy, and residual vascular risk: an analysis from the JUPITER Trial (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin). Circulation. 2014 Feb 11;129(6):635-42. doi: 10.1161/CIRCULATIONAHA.113.004406. Epub 2013 Nov 17.
PubMed 24243886

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo Controlled, Multicenter, Phase 3 Study of Rosuvastatin (CRESTOR®) 20 mg in the Prevention of Cardiovascular Events Among Subjects With Low Levels of Low Density Lipoprotein(LDL) Cholesterol & Elevated Levels of C-Reactive Protein
ClinicalTrials.gov ID: NCT00239681
Acronym / sponsor ID: D3560L00030
Conditions: Elevated High-sensitivity C-Reactive Protein (hsCRP)
Keywords: Primary prevention, Cardiovascular disease, Statin therapy, C-reactive protein
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: See detailed description for reason.
Enrolment: 17,802 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Feb 2003
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 17 Oct 2005 (estimated)
Results: Posted 24 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Rosuvastatin	Experimental	Drug: RosuvastatinRosuvastatin 20 mg once daily
Placebo	Placebo comparator	Other: PlaceboPlacebo once daily

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Men 50 years or older, women 60 years or older
Low to normal levels of low density lipoprotein (LDL) cholesterol (< 130mg/dL)
Elevated levels of C-Reactive Protein (CRP) > 2.0 mg/L

Key exclusion criteria (7 listed)

History of cardiovascular or cerebrovascular events
Active liver disease
Diabetes mellitus
Uncontrolled hypertension or hypothyroidism
History of certain malignancies

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RosuvastatinAlso: CrestorOral	Drug	Rosuvastatin
PlaceboOral	Other	Placebo

Primary outcome

Time to Major Cardiac Event (Cardiovascular Death, Stroke, Myocardial Infarction, Hospitalization Due to Unstable Angina or Arterial Revascularization)
Time frame: up to 5 years
Days from randomization to the first of CV death, stroke, MI, hospitalization for unstable angina or arterial revascularization. If no event, censoring occurs at earliest of termination date or efficacy cut-off date of 30 Mar 2008. Events were adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean

5 secondary outcomes

Time to Death Due to Any Cause
Time frame: up to 5 years
Time to Non-cardiovascular Death
Time frame: up to 5 years
Time to Development of Diabetes Mellitus
Time frame: up to 5 years
Time to Venous Thromboembolic Event
Time frame: up to 5 years
Time to Bone Fracture
Time frame: Up to 5 years

Results and safety

Results posted to the registry on 24 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rosuvastatin	8,901	8,208
Placebo	8,901	8,186

Primary outcome: Time to Major Cardiac Event (Cardiovascular Death, Stroke, Myocardial Infarction, Hospitalization Due to Unstable Angina or Arterial Revascularization)

Time frame: up to 5 years. Mean (Standard Error). Unit: Days

Measure	Rosuvastatin n = 8901	Placebo n = 8901
Value	1646.4 (2.76)	1578.3 (3.49)

Rosuvastatin vs Placebo: Hazard Ratio (HR): 0.56 (95% CI 0.46 to 0.69), p <0.0001, Regression, Cox

Population analysed: Intention to treat population

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PLACEBO	1,216 of 8,864 (13.7%)	3,170 of 8,864 (35.8%)	Not reported
ROSUVASTATIN 20 MG	1,205 of 8,869 (13.6%)	3,228 of 8,869 (36.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38841856Hoshi RA, Alotaibi M, Liu Y, Watrous JD, Ridker PM, Glynn RJ, Serhan CN, Luttmann-Gibson H, Moorthy MV, Jain M, Demler OV, Mora S. One-Year Effects of High-Intensity Statin on Bioactive Lipids: Findings From the JUPITER Trial. Arterioscler Thromb Vasc Biol. 2024 Jul;44(7):e196-e206. doi: 10.1161/ATVBAHA.124.321058. Epub 2024 Jun 6.
Derived from this study: PubMed 38018702Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.
Derived from this study: PubMed 32799709Ajala ON, Demler OV, Liu Y, Farukhi Z, Adelman SJ, Collins HL, Ridker PM, Rader DJ, Glynn RJ, Mora S. Anti-Inflammatory HDL Function, Incident Cardiovascular Events, and Mortality: A Secondary Analysis of the JUPITER Randomized Clinical Trial. J Am Heart Assoc. 2020 Sep;9(17):e016507. doi: 10.1161/JAHA.119.016507. Epub 2020 Aug 15.
Derived from this study: PubMed 31070471Akinkuolie AO, Lawler PR, Chu AY, Caulfield M, Mu J, Ding B, Nyberg F, Glynn RJ, Ridker PM, Hurt-Camejo E, Chasman DI, Mora S. Group IIA Secretory Phospholipase A2, Vascular Inflammation, and Incident Cardiovascular Disease. Arterioscler Thromb Vasc Biol. 2019 Jun;39(6):1182-1190. doi: 10.1161/ATVBAHA.118.311894.
Derived from this study: PubMed 30033433Dagenais GR, Jung H, Lonn E, Bogaty PM, Dehghan M, Held C, Avezum A, Jansky P, Keltai M, Leiter LA, Lopez-Jaramillo P, Toff WD, Bosch J, Yusuf S. Effects of Lipid-Lowering and Antihypertensive Treatments in Addition to Healthy Lifestyles in Primary Prevention: An Analysis of the HOPE-3 Trial. J Am Heart Assoc. 2018 Jul 22;7(15):e008918. doi: 10.1161/JAHA.118.008918.
Derived from this study: PubMed 28450350Khera AV, Demler OV, Adelman SJ, Collins HL, Glynn RJ, Ridker PM, Rader DJ, Mora S. Cholesterol Efflux Capacity, High-Density Lipoprotein Particle Number, and Incident Cardiovascular Events: An Analysis From the JUPITER Trial (Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin). Circulation. 2017 Jun 20;135(25):2494-2504. doi: 10.1161/CIRCULATIONAHA.116.025678. Epub 2017 Apr 27.
Derived from this study: PubMed 27413042Akinkuolie AO, Glynn RJ, Padmanabhan L, Ridker PM, Mora S. Circulating N-Linked Glycoprotein Side-Chain Biomarker, Rosuvastatin Therapy, and Incident Cardiovascular Disease: An Analysis From the JUPITER Trial. J Am Heart Assoc. 2016 Jul 13;5(7):e003822. doi: 10.1161/JAHA.116.003822.
Derived from this study: PubMed 27347563Dugani SB, Akinkuolie AO, Paynter N, Glynn RJ, Ridker PM, Mora S. Association of Lipoproteins, Insulin Resistance, and Rosuvastatin With Incident Type 2 Diabetes Mellitus : Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2016 May 1;1(2):136-45. doi: 10.1001/jamacardio.2016.0096.
Derived from this study: PubMed 26951635Lawler PR, Akinkuolie AO, Chandler PD, Moorthy MV, Vandenburgh MJ, Schaumberg DA, Lee IM, Glynn RJ, Ridker PM, Buring JE, Mora S. Circulating N-Linked Glycoprotein Acetyls and Longitudinal Mortality Risk. Circ Res. 2016 Apr 1;118(7):1106-15. doi: 10.1161/CIRCRESAHA.115.308078. Epub 2016 Mar 7.
Derived from this study: PubMed 26408274Mora S, Caulfield MP, Wohlgemuth J, Chen Z, Superko HR, Rowland CM, Glynn RJ, Ridker PM, Krauss RM. Atherogenic Lipoprotein Subfractions Determined by Ion Mobility and First Cardiovascular Events After Random Allocation to High-Intensity Statin or Placebo: The Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) Trial. Circulation. 2015 Dec 8;132(23):2220-9. doi: 10.1161/CIRCULATIONAHA.115.016857. Epub 2015 Sep 25.
Derived from this study: PubMed 26273092Chu AY, Giulianini F, Barratt BJ, Ding B, Nyberg F, Mora S, Ridker PM, Chasman DI. Differential Genetic Effects on Statin-Induced Changes Across Low-Density Lipoprotein-Related Measures. Circ Cardiovasc Genet. 2015 Oct;8(5):688-95. doi: 10.1161/CIRCGENETICS.114.000962. Epub 2015 Aug 13.
Derived from this study: PubMed 25825410Everett BM, Zeller T, Glynn RJ, Ridker PM, Blankenberg S. High-sensitivity cardiac troponin I and B-type natriuretic Peptide as predictors of vascular events in primary prevention: impact of statin therapy. Circulation. 2015 May 26;131(21):1851-60. doi: 10.1161/CIRCULATIONAHA.114.014522. Epub 2015 Mar 30.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Judith Hsia, MD study director

AstraZeneca

Paul Ridker, MD study chair

Brigham and Women's Hospital

856 sites in 27 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rosuvastatin in people with Elevated High-sensitivity C-Reactive Protein (hsCRP), run by AstraZeneca at 856 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 856 sites in United States, Canada, Belgium, Poland, Norway and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Major Cardiac Event (Cardiovascular Death, Stroke, Myocardial Infarction, Hospitalization Due to Unstable Angina or Arterial Revascularization) (time frame: up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00239681, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2014.