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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

Tracking Information
First Submitted Date  ICMJE October 13, 2005
First Posted Date  ICMJE October 17, 2005
Results First Submitted Date August 20, 2009
Results First Posted Date March 24, 2014
Last Update Posted Date March 24, 2014
Study Start Date  ICMJE February 2003
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2014)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 13, 2005)
Investigate whether long-term treatment with rosuvastatin compared with placebo will decrease the rate of major cardiovascular events
Change History Complete list of historical versions of study NCT00239681 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2014)
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2005)
  • - 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.
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE JUPITER - Crestor 20mg Versus Placebo in Prevention of Cardiovascular (CV) Events
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Elevated High-sensitivity C-Reactive Protein (hsCRP)
Intervention  ICMJE
  • Drug: Rosuvastatin
    Oral
    Other Name: Crestor
  • Other: Placebo
    Oral
Study Arms
  • Experimental: Rosuvastatin
    Rosuvastatin 20 mg once daily
    Intervention: Drug: Rosuvastatin
  • Placebo Comparator: Placebo
    Placebo once daily
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 6, 2014)
17802
Original Enrollment  ICMJE
 (submitted: October 13, 2005)
15000
Actual Study Completion Date September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   Colombia,   Costa Rica,   Denmark,   El Salvador,   Estonia,   Germany,   Israel,   Mexico,   Netherlands,   Norway,   Panama,   Poland,   Puerto Rico,   Romania,   Russian Federation,   South Africa,   Switzerland,   United Kingdom,   United States,   Uruguay,   Venezuela
Removed Location Countries Guatemala
 
Administrative Information
NCT Number  ICMJE NCT00239681
Other Study ID Numbers  ICMJE D3560L00030
Jupiter
4522US/0011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Judith Hsia, MD AstraZeneca
Study Chair: Paul Ridker, MD Brigham and Women's Hospital
PRS Account AstraZeneca
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP