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

This study has been terminated.
(See detailed description for reason.)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00239681
First received: October 13, 2005
Last updated: February 3, 2009
Last verified: February 2009
History of Changes
  Purpose

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 Intervention Phase
Elevated hs C-Reactive Protein
 Drug: Rosuvastatin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 LDL Cholesterol & Elevated Levels of C-Reactive Protein

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Investigate whether long-term treatment with rosuvastatin compared with placebo will decrease the rate of major cardiovascular events

Secondary Outcome Measures:
  • Investigate the safety of long-term treatment with rosuvastatin compared with placebo through comparisons of total mortality, noncardiovascular mortality, & adverse events
  • Investigate whether therapy with rosuvastatin reduces the incidence of diabetes mellitus, venous thromboembolic events, & the incidence of bone fractures.

Estimated Enrollment: 15000
Study Start Date: February 2003
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Rosuvastatin
    Other Name: Crestor
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239681

  Show 859 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Judith Hsia, MD AstraZeneca
Study Chair: Paul Ridker, MD Brigham and Women's Hospital
  More Information

No publications provided by AstraZeneca

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

Responsible Party: Michael Cressman / Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00239681     History of Changes
Other Study ID Numbers: D3560L00030, Jupiter, 4522US/0011
Study First Received: October 13, 2005
Last Updated: February 3, 2009
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 22, 2013