Elevated High-sensitivity C-Reactive Protein (hsCRP) Clinical Trial
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
| Verified date | February 2014 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 17802 |
| Est. completion date | September 2008 |
| Est. primary completion date | September 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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|---|---|---|---|
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| United States | Research Site | Fort Collins | Colorado |
| United States | Research Site | Fort Lauderdale | Florida |
| United States | Research Site | Fort Worth | Texas |
| United States | Research Site | Fountain Valley | California |
| United States | Research Site | Fresno | California |
| United States | Research Site | Friendswood | Texas |
| United States | Research Site | Ft Worth | Texas |
| United States | Research Site | Gainesville | Florida |
| United States | Research Site | Garden Grove | California |
| United States | Research Site | Germantown | Tennessee |
| United States | Research Site | Gig Harbor | Washington |
| United States | Research Site | Glen Burnie | Maryland |
| United States | Research Site | Golden | Colorado |
| United States | Research Site | Grand Island | Nebraska |
| United States | Research Site | Grand Rapids | Michigan |
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| United States | Research Site | Grapevine | Texas |
| United States | Research Site | Graysville | Alabama |
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| United States | Research Site | Greer | South Carolina |
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| United States | Research Site | Gurnee | Illinois |
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| United States | Research Site | Hagerstown | Maryland |
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| United States | Research Site | Hampton | South Carolina |
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| United States | Research Site | Hayes | Virginia |
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| United States | Research Site | Highlands Ranch | Colorado |
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| United States | Research Site | Idaho Falls | Idaho |
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| United States | Research Site | Jefferson City | Missouri |
| United States | Research Site | Jefferson City | Tennessee |
| United States | Research Site | Jeffersonville | Indiana |
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| United States | Research Site | Johnson City | Tennessee |
| United States | Research Site | Johnston | Rhode Island |
| United States | Research Site | Kalispell | Montana |
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| United States | Research Site | King of Prussia | Pennsylvania |
| United States | Research Site | La Jolla | California |
| United States | Research Site | La Mesa | California |
| United States | Research Site | Lake Charles | Louisiana |
| United States | Research Site | Lake Jackson | Texas |
| United States | Research Site | Lake Oswego | Oregon |
| United States | Research Site | Lake Road | Illinois |
| United States | Research Site | Lake Success | New York |
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| United States | Research Site | Languna Niguel | California |
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| United States | Research Site | Lewisburg | West Virginia |
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| United States | Research Site | Los Alamos | New Mexico |
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| United States | Research Site | Louisville | Kentucky |
| United States | Research Site | Loveland | Colorado |
| United States | Research Site | Lubbock | Texas |
| United States | Research Site | Madison | Wisconsin |
| United States | Research Site | Mamaroneck | New York |
| United States | Research Site | Manchester | Missouri |
| United States | Research Site | Mansfield | Ohio |
| United States | Research Site | Margate | Florida |
| United States | Research Site | Marrero | Louisiana |
| United States | Research Site | Massillon | Ohio |
| United States | Research Site | Maumee | Ohio |
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| United States | Research Site | Medford | Oregon |
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| United States | Research Site | Melrose Park | Illinois |
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| United States | Research Site | Menomonee Falls | Wisconsin |
| United States | Research Site | Meridian | Idaho |
| United States | Research Site | Mesa | Arizona |
| United States | Research Site | Mexico | Missouri |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Milwaukee | Wisconsin |
| United States | Research Site | Milwaukie | Oregon |
| United States | Research Site | Minneapolis | Minnesota |
| United States | Research Site | Mission Hills | California |
| United States | Research Site | Mission Viejo | California |
| United States | Research Site | Missoula | Montana |
| United States | Research Site | Mobile | Alabama |
| United States | Research Site | Modesto | California |
| United States | Research Site | Moncks Corner | South Carolina |
| United States | Research Site | Montgomery | Alabama |
| United States | Research Site | Morristown | New Jersey |
| United States | Research Site | Morristown | Tennessee |
| United States | Research Site | Morton | Illinois |
| United States | Research Site | Mount Vernon | New York |
| United States | Research Site | Mt Pleasant | South Carolina |
| United States | Research Site | Munster | Indiana |
| United States | Research Site | Muscle Shoals | Alabama |
| United States | Research Site | Muskogee | Oklahoma |
| United States | Research Site | N Richland Hills | Texas |
| United States | Research Site | Nashua | New Hampshire |
| United States | Research Site | Nashville | Tennessee |
| United States | Research Site | Natick | Massachusetts |
| United States | Research Site | Nephi | Utah |
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| United States | Research Site | New Hartford | New York |
| United States | Research Site | New Hyde Park | New York |
| United States | Research Site | New Orleans | Louisiana |
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| United States | Research Site | Newark | Delaware |
| United States | Research Site | Newburgh | Indiana |
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| United States | Research Site | Northbrunswick | New Jersey |
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| United States | Research Site | Oklahoma City | Oklahoma |
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| United States | Research Site | Olive Branch | Mississippi |
| United States | Research Site | Olympia | Washington |
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| United States | Research Site | Palm Harbor | Florida |
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| United States | Research Site | Pawtucket | Rhode Island |
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| United States | Research Site | Portland | Oregon |
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| United States | Research Site | Rochester | New York |
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| United States | Research Site | Roseville | California |
| United States | Research Site | S Portland | Maine |
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| United States | Research Site | Scotland | Pennsylvania |
| United States | Research Site | Scottsdale | Arizona |
| United States | Research Site | Seattle | Washington |
| United States | Research Site | Sebastian | Florida |
| United States | Research Site | Seguin | Texas |
| United States | Research Site | Sellersville | Pennsylvania |
| United States | Research Site | Shawnee Mission | Missouri |
| United States | Research Site | Shawnee Mission | Kansas |
| United States | Research Site | Shreveport | Louisiana |
| United States | Research Site | Simpsonville | South Carolina |
| United States | Research Site | Sioux Falls | South Dakota |
| United States | Research Site | Souderton | Pennsylvania |
| United States | Research Site | South Birmingham | Alabama |
| United States | Research Site | Spokane | Washington |
| United States | Research Site | Springfield | Virginia |
| United States | Research Site | Springfield | Massachusetts |
| United States | Research Site | Springfield | Illinois |
| United States | Research Site | Springfield | Pennsylvania |
| United States | Research Site | Springfield | Oregon |
| United States | Research Site | Springfield | Missouri |
| United States | Research Site | St Charles | Missouri |
| United States | Research Site | St Louis | Missouri |
| United States | Research Site | St. Joseph | Michigan |
| United States | Research Site | St. Paul | Minnesota |
| United States | Research Site | Stamford | Connecticut |
| United States | Research Site | State College | Pennsylvania |
| United States | Research Site | Statesville | North Carolina |
| United States | Research Site | Sterling | Illinois |
| United States | Research Site | Stoneboro | Pennsylvania |
| United States | Research Site | Stuart | Virginia |
| United States | Research Site | Suffolk | Virginia |
| United States | Research Site | Sugar Land | Texas |
| United States | Research Site | Suwanee | Georgia |
| United States | Research Site | Syracuse | New York |
| United States | Research Site | Tamarac | Florida |
| United States | Research Site | Tampa | Florida |
| United States | Research Site | Teaneck | New Jersey |
| United States | Research Site | The Woodlands | Texas |
| United States | Research Site | Thousand Oaks | California |
| United States | Research Site | Tipton | Pennsylvania |
| United States | Research Site | Tonawanda | New York |
| United States | Research Site | Topeka | Kansas |
| United States | Research Site | Torrance | California |
| United States | Research Site | Towson | Maryland |
| United States | Research Site | Trenton | New Jersey |
| United States | Research Site | Troy | Michigan |
| United States | Research Site | Trumbull | Connecticut |
| United States | Research Site | Tucson | Arizona |
| United States | Research Site | Tulsa | Oklahoma |
| United States | Research Site | Tuscumbia | Alabama |
| United States | Research Site | Tyler | Texas |
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| United States | Research Site | Upland | Pennsylvania |
| United States | Research Site | Upland | California |
| United States | Research Site | Valparaiso | Indiana |
| United States | Research Site | Ventura | California |
| United States | Research Site | Vernon Hills | Illinois |
| United States | Research Site | Vero Beach | Florida |
| United States | Research Site | Vista | California |
| United States | Research Site | Wadsworth | Ohio |
| United States | Research Site | Wallingford | Pennsylvania |
| United States | Research Site | Walnut Creek | California |
| United States | Research Site | Warminster | Pennsylvania |
| United States | Research Site | Warren | Ohio |
| United States | Research Site | Warren | Michigan |
| United States | Research Site | Washington | Missouri |
| United States | Research Site | Washington | District of Columbia |
| United States | Research Site | Weber City | Virginia |
| United States | Research Site | Wenatchee | Washington |
| United States | Research Site | Wentzville | Missouri |
| United States | Research Site | West Caldwell | New Jersey |
| United States | Research Site | West Des Moines | Iowa |
| United States | Research Site | West Grove | Pennsylvania |
| United States | Research Site | West Hartford | Connecticut |
| United States | Research Site | West Palm Beach | Florida |
| United States | Research Site | West Reading | Pennsylvania |
| United States | Research Site | West Yarmouth | Massachusetts |
| United States | Research Site | Westlake Village | California |
| United States | Research Site | Wichita | Kansas |
| United States | Research Site | Wilkes-barre | Pennsylvania |
| United States | Research Site | Williamsville | New York |
| United States | Research Site | Winston-salem | North Carolina |
| United States | Research Site | Wlimington | Delaware |
| United States | Research Site | Woodstock | Georgia |
| United States | Research Site | Worcester | Massachusetts |
| United States | Research Site | York | Pennsylvania |
| United States | Research Site | Yorktown | Virginia |
| United States | Research Site | Yukon | Oklahoma |
| United States | Research Site | Zanesville | Ohio |
| Uruguay | Research Site | Montevideo | |
| Venezuela | Research Site | Barinas | Estado Barinas |
| Venezuela | Research Site | Barquisimeto | Estado Lara |
| Venezuela | Research Site | Caracas | |
| Venezuela | Research Site | Ciudad Bolivar | Estado Bolivar |
| Venezuela | Research Site | Latrinidad Caracas | Municipio Baruta |
| Venezuela | Research Site | Maracaibo | Estado Zulia |
| Venezuela | Research Site | Maracay, Municipio Girardot | Estado Aragua |
| Venezuela | Research Site | Merida | Estado Merida |
| Venezuela | Research Site | Porlamar | Estado Nueva Esparta |
| Venezuela | Research Site | Puerto Ordaz | Estado Bolivar |
| Venezuela | Research Site | Punto Fijo, Estado Falcon | |
| Venezuela | Research Site | Valencia | Estado Carabobo |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Uruguay, Venezuela, Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Denmark, El Salvador, Estonia, Germany, Israel, Mexico, Netherlands, Norway, Panama, Poland, Puerto Rico, Romania, Russian Federation, South Africa, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | up to 5 years | No |
| Secondary | 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 | up to 5 years | No |
| Secondary | 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 | up to 5 years | No |
| Secondary | 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 | up to 5 years | No |
| Secondary | Time to Venous Thromboembolic Event | Time from randomization to the first venous thromboembolic event. Kaplan-Meier estimate of the mean | up to 5 years | No |
| Secondary | 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 | Up to 5 years | No |