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

October 13, 2005
February 6, 2014
February 2003
September 2008   (final data collection date for primary outcome measure)
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
Investigate whether long-term treatment with rosuvastatin compared with placebo will decrease the rate of major cardiovascular events
Complete list of historical versions of study NCT00239681 on ClinicalTrials.gov Archive Site
  • 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
  • - 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.
Not Provided
Not Provided
 
JUPITER - Crestor 20mg Versus Placebo in Prevention of Cardiovascular (CV) Events
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Elevated High-sensitivity C-Reactive Protein (hsCRP)
  • Drug: Rosuvastatin
    Oral
    Other Name: Crestor
  • Other: Placebo
    Oral
  • Experimental: Rosuvastatin
    Rosuvastatin 20 mg once daily
    Intervention: Drug: Rosuvastatin
  • Placebo Comparator: Placebo
    Placebo once daily
    Intervention: Other: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
17802
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Venezuela,   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,   Uruguay
 
NCT00239681
D3560L00030, Jupiter, 4522US/0011
Yes
AstraZeneca
AstraZeneca
Not Provided
Study Director: Judith Hsia, MD AstraZeneca
Study Chair: Paul Ridker, MD Brigham and Women's Hospital
AstraZeneca
February 2014

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