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
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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
Participants were recruited from dialysis clinics and hospitals between August 2006 to Jan 2008 from 22 countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were screened over a 30 day period.

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.

Participant Flow:   Overall Study
    Cinacalcet     Placebo  
STARTED     1948 [1]   1935 [2]
COMPLETED     1799 [3]   1776 [3]
NOT COMPLETED     149     159  
Withdrawal by Subject                 91                 98  
Lost to Follow-up                 58                 61  
[1] Randomized to cinacalcet
[2] Randomized to placebo
[3] Participants who completed study includes those with ended study due to death.



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

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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