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

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ClinicalTrials.gov Identifier: NCT00239681
Recruitment Status : Terminated (See detailed description for reason.)
First Posted : October 17, 2005
Results First Posted : March 24, 2014
Last Update Posted : March 24, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Elevated High-sensitivity C-Reactive Protein (hsCRP) Drug: Rosuvastatin Other: Placebo Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17802 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : February 2003
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Rosuvastatin
Rosuvastatin 20 mg once daily
 Drug: Rosuvastatin
Oral
Other Name: Crestor
Placebo Comparator: Placebo
Placebo once daily
 Other: Placebo
Oral


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Time to Death Due to Any Cause [ Time Frame: up to 5 years ]
    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

  2. Time to Non-cardiovascular Death [ Time Frame: up to 5 years ]
    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

  3. Time to Development of Diabetes Mellitus [ Time Frame: up to 5 years ]
    Days from randomization until development of diabetes. If no diabetes was developed censoring occurred at termination date. Kaplan-Meier estimate of the mean

  4. Time to Venous Thromboembolic Event [ Time Frame: up to 5 years ]
    Time from randomization to the first venous thromboembolic event. Kaplan-Meier estimate of the mean

  5. Time to Bone Fracture [ Time Frame: Up to 5 years ]
    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


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00239681


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Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Judith Hsia, MD AstraZeneca
Study Chair: Paul Ridker, MD Brigham and Women's Hospital
More Information
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00239681     History of Changes
Other Study ID Numbers: D3560L00030
Jupiter
4522US/0011
First Posted: October 17, 2005    Key Record Dates
Results First Posted: March 24, 2014
Last Update Posted: March 24, 2014
Last Verified: February 2014

Keywords provided by AstraZeneca:
Primary prevention
Cardiovascular disease
Statin therapy
C-reactive protein

Additional relevant MeSH terms:
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors