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E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events (EVOLVE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00345839
First received: June 27, 2006
Last updated: July 11, 2014
Last verified: July 2014
Results First Received: June 6, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Secondary Hyperparathyroidism
Chronic Kidney Disease
Interventions: Drug: Cinacalcet
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
Cinacalcet Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
Placebo Participants were given matching placebo tablets compared to the cinacalcet group.
Total Total of all reporting groups

Baseline Measures
   Cinacalcet   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 1948   1935   3883 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.8  (14.5)   54.0  (14.2)   54.4  (14.4) 
Gender 
[Units: Participants]
     
Female   809   769   1578 
Male   1139   1166   2305 
Race/Ethnicity, Customized 
[Units: Participants]
     
White or Caucasian   1124   1116   2240 
Black or African American   409   428   837 
Hispanic or Latino   317   310   627 
Asian   47   38   85 
Japanese   4   1   5 
American Indian or Alaska Native   5   7   12 
Native Hawaiian or Other Pacific Islander   12   9   21 
Aborigine   1   4   5 
Other   29   22   51 
History of Diabetes Stratification Factor [1] 
[Units: Participants]
     
Diabetes   619   614   1233 
No Diabetes   1329   1321   2650 
[1] History of diabetes stratification factor from the interactive voice response system.
Country stratification factor [1] 
[Units: Participants]
     
Argentina   171   170   341 
Australia   74   75   149 
Austria   31   29   60 
Belgium   50   50   100 
Brazil   151   150   301 
Canada   73   73   146 
Denmark   8   11   19 
France   40   40   80 
Germany   81   81   162 
Hungary   66   67   133 
Ireland   5   6   11 
Italy   69   68   137 
Mexico   23   22   45 
Netherlands   15   14   29 
Poland   59   57   116 
Portugal   22   21   43 
Russia   143   140   283 
Spain   40   38   78 
Sweden   13   10   23 
Switzerland   18   19   37 
United Kingdom   81   79   160 
United States   715   715   1430 
[1] Country stratification factor from the interactive voice response system. Denmark and Sweden were combined to create Nordic stratum.


  Outcome Measures
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1.  Primary:   Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event)   [ Time Frame: From date of randomization until date of first confirmed primary composite endpoint event, assessed up to 5.4 years ]

2.  Secondary:   Time to All-cause Mortality   [ Time Frame: From date of randomization until date of confirmed all-cause mortality endpoint event, assessed up to 5.4 years ]

3.  Secondary:   Time to Myocardial Infarction   [ Time Frame: From date of randomization until date of first confirmed myocardial infarction endpoint event, assessed up to 5.4 years ]

4.  Secondary:   Time to Hospitalization for Unstable Angina   [ Time Frame: From date of randomization until date of first confirmed hospitalization for unstable angina endpoint event, assessed up to 5.4 years ]

5.  Secondary:   Time to Heart Failure   [ Time Frame: From date of randomization until date of first confirmed heart failure endpoint event, assessed up to 5.4 years ]

6.  Secondary:   Time to Peripheral Vascular Event   [ Time Frame: From date of randomization until date of first confirmed peripheral vascular endpoint event, assessed up to 5.4 years ]

7.  Secondary:   Time to Cardiovascular Mortality   [ Time Frame: From date of randomization until date of first confirmed cardiovascular mortality endpoint event, assessed up to 5.4 years ]

8.  Secondary:   Time to Stroke   [ Time Frame: From date of randomization until date of first confirmed stroke endpoint event, assessed up to 5.4 years ]

9.  Secondary:   Time to Bone Fracture   [ Time Frame: From date of randomization until date of first confirmed bone fracture endpoint event, assessed up to 5.4 years ]

10.  Secondary:   Time to Parathyroidectomy   [ Time Frame: From date of randomization until date of first confirmed parathyroidectomy endpoint event, assessed up to 5.4 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