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JUPITER - Crestor 20mg Versus...

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

Last Updated: 2014-03-24

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

17802 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2008-09-30

Brief Summary

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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.

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Detailed Description

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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

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Elevated High-sensitivity C-Reactive Protein (hsCRP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rosuvastatin

Rosuvastatin 20 mg once daily

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

Oral

Placebo

Placebo once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Oral

Interventions

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Rosuvastatin

Oral

Intervention Type DRUG

Placebo

Oral

Intervention Type OTHER

Other Intervention Names

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Crestor

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers