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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
17,802
Oral
Oral
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
Time frame: up to 5 years
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
Time frame: 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
Time frame: 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
Time frame: up to 5 years
Time to Venous Thromboembolic Event
Time from randomization to the first venous thromboembolic event. Kaplan-Meier estimate of the mean
Time frame: 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
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Research Site
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Calera, Alabama, United States
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...and 846 more locations
Time frame: Up to 5 years