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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 (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00239681
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
  Description
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.
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Reporting Groups
  Description
Rosuvastatin Rosuvastatin 20 mg once daily
Placebo Placebo once daily
Total Total of all reporting groups

Baseline Measures
   Rosuvastatin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 8901   8901   17802 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.1  (7.64)   66.1  (7.8)   66.1  (7.72) 
Gender 
[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
e-mail: ClinicalTrialTransparency@astrazeneca.com


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