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 (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00239681
First received: October 13, 2005
Last updated: February 6, 2014
Last verified: February 2014
  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 High-sensitivity C-Reactive Protein (hsCRP)
Drug: Rosuvastatin
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to Major Cardiac Event (Cardiovascular Death, Stroke, Myocardial Infarction, Hospitalization Due to Unstable Angina or Arterial Revascularization) [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    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:
  • Time to Death Due to Any Cause [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    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 to Non-cardiovascular Death [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    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 to Development of Diabetes Mellitus [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    Days from randomization until development of diabetes. If no diabetes was developed censoring occurred at termination date. Kaplan-Meier estimate of the mean

  • Time to Venous Thromboembolic Event [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    Time from randomization to the first venous thromboembolic event. Kaplan-Meier estimate of the mean

  • Time to Bone Fracture [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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


Enrollment: 17802
Study Start Date: February 2003
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rosuvastatin
Rosuvastatin 20 mg once daily
Drug: Rosuvastatin
Oral
Other Name: Crestor
Placebo Comparator: Placebo
Placebo once daily
Other: Placebo
Oral

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided by AstraZeneca

Additional 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
Study First Received: October 13, 2005
Results First Received: August 20, 2009
Last Updated: February 6, 2014
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 July 23, 2014