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

AstraZeneca logo

AstraZeneca

Status and phase

Terminated
Phase 3

Conditions

Elevated High-sensitivity C-Reactive Protein (hsCRP)

Treatments

Other: Placebo
Drug: Rosuvastatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00239681
4522US/0011
Jupiter
D3560L00030

Details and patient eligibility

About

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.

Full 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.

Enrollment

17,802 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

17,802 participants in 2 patient groups, including a placebo group

Rosuvastatin
Experimental group
Description:
Rosuvastatin 20 mg once daily
Treatment:
Drug: Rosuvastatin
Placebo
Placebo Comparator group
Description:
Placebo once daily
Treatment:
Other: Placebo

Trial contacts and locations

859

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Data sourced from clinicaltrials.gov

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