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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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
  Description
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  
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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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


No publications provided by AstraZeneca

Publications automatically indexed to this study:


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