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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.)
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: October 13, 2005
Last updated: February 6, 2014
Last verified: February 2014
Results First Received: August 20, 2009  
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
Condition: Elevated High-sensitivity C-Reactive Protein (hsCRP)
Interventions: Drug: Rosuvastatin
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The first subject was enrolled on 05 February 2003. The last subject completed on 20 August 2008. Study subjects were randomized at 1348 centers in 26 countries. Enrolled subjects participated in an initial 4-week, run-in phase and received placebo therapy.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
If found eligible for the main study on the basis of appropriate levels of baseline Low Density Lipoprotein (LDL), High-sensitivity C-Reactive Protein (hsCRP), and run-in phase compliance (>80% of pills taken), subjects were randomized to either rosuvastatin 20 mg or placebo once daily

Reporting Groups
Rosuvastatin Rosuvastatin 20 mg once daily
Placebo Placebo once daily

Participant Flow:   Overall Study
    Rosuvastatin     Placebo  
STARTED     8901     8901  
Randomized and Treated (Safety Pop)     8869     8864  
COMPLETED     8208     8186  
NOT COMPLETED     693     715  
Adverse Event                 100                 99  
Withdrawal by Subject                 458                 489  
Lost to Follow-up                 28                 22  
Protocol Violation                 4                 4  
Physician Decision                 13                 17  
No information chacked on CaseReportForm                 90                 84  

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Rosuvastatin Rosuvastatin 20 mg once daily
Placebo Placebo once daily
Total Total of all reporting groups

Baseline Measures
    Rosuvastatin     Placebo     Total  
Number of Participants  
[units: participants]
  8901     8901     17802  
[units: years]
Mean (Standard Deviation)
  66.1  (7.64)     66.1  (7.8)     66.1  (7.72)  
[units: Participants]
Female     3426     3375     6801  
Male     5475     5526     11001  

  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Major Cardiac Event (Cardiovascular Death, Stroke, Myocardial Infarction, Hospitalization Due to Unstable Angina or Arterial Revascularization)   [ Time Frame: up to 5 years ]

2.  Secondary:   Time to Death Due to Any Cause   [ Time Frame: up to 5 years ]

3.  Secondary:   Time to Non-cardiovascular Death   [ Time Frame: up to 5 years ]

4.  Secondary:   Time to Development of Diabetes Mellitus   [ Time Frame: up to 5 years ]

5.  Secondary:   Time to Venous Thromboembolic Event   [ Time Frame: up to 5 years ]

6.  Secondary:   Time to Bone Fracture   [ Time Frame: Up to 5 years ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Torbjorn Lundstrom
Organization: AstraZeneca

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: AstraZeneca Identifier: NCT00239681     History of Changes
Other Study ID Numbers: D3560L00030
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