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Study of Heart and Renal Protection (SHARP)

This study has been completed.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Schering-Plough
National Health and Medical Research Council, Australia
British Heart Foundation
Medical Research Council
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT00125593
First received: July 29, 2005
Last updated: January 31, 2012
Last verified: January 2012
Results First Received: August 19, 2011  
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: Kidney Disease, Chronic
Interventions: Drug: Simvastatin 20 mg
Drug: Ezetimibe 10mg
Drug: Placebo

  Participant Flow


  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
Simvastatin Plus Ezetimibe Once daily tablet
Placebo Once daily tablet
Total Total of all reporting groups

Baseline Measures
    Simvastatin Plus Ezetimibe     Placebo     Total  
Number of Participants  
[units: participants]
  4650     4620     9270  
Age  
[units: Years]
Mean ± Standard Deviation
  62  ± 12     62  ± 12     62  ± 12  
Gender  
[units: participants]
     
Female     1735     1735     3470  
Male     2915     2885     5800  
Renal status  
[units: Participants]
     
On dialysis     1533     1490     3023  
Not on dialysis     3117     3130     6247  



  Outcome Measures
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1.  Primary:   Key Outcome as Per Statistical Analysis Plan = Major Atherosclerotic Events Among All Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo   [ Time Frame: Median follow-up 4.9 years ]

2.  Secondary:   Major Vascular Events Analyzed Among All Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo   [ Time Frame: Median follow-up 4.9 years ]

3.  Secondary:   Major Vascular Events Analyzed Amongst Patients Initially Randomized to Simvastatin Plus Ezetimibe Versus Placebo (Original Protocol-defined Primary Outcome)   [ Time Frame: Median follow-up 4.9 years ]

4.  Secondary:   Major Coronary Events Among All Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo   [ Time Frame: Median follow-up 4.9 years ]

5.  Secondary:   Non-hemorrhagic Stroke Among All of Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo   [ Time Frame: Median follow-up 4.9 years ]

6.  Secondary:   Coronary or Non-coronary Revascularization Among All Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo   [ Time Frame: Median follow-up 4.9 years ]

7.  Secondary:   End-stage Renal Disease Among All Patients Not on Dialysis at the Time of Randomization to Simvastatin Plus Ezetimibe Versus Placebo   [ Time Frame: Median follow-up 4.9 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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