Study Complete
Sponsor ID
20050182
E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular EventsEVOLVE
Study Details
The purpose of this study is to evaluate the effects of cinacalcet (cinacalcet HCl or Sensipar®/Mimpara®) on cardiovascular events and death in chronic kidney disease (CKD) patients with secondary hyperparathyroidism (HPT) who are receiving dialysis.
Protocol Summary
Primary Outcome Measures
Time to the composite event comprising all-cause mortality or non-fatal cardiovascular events (MI, hospitalization for unstable angina, HF, or peripheral vascular event)
Timeframe: estimated 2.5 to 4 years
Secondary Outcome Measures
Time to all-cause mortality
Timeframe: estimated 2.5 to 4 years
Time to cardiovascular mortality
Timeframe: estimated 2.5 to 4 years
Time to fatal and non-fatal MI
Timeframe: estimated 2.5 to 4 years
Time to fatal and non-fatal hospitalization for unstable angina
Timeframe: estimated 2.5 to 4 years
Time to fatal and non-fatal HF event
Timeframe: estimated 2.5 to 4 years
Time to fatal and non-fatal peripheral vascular event
Timeframe: estimated 2.5 to 4 years
Time to fatal and non-fatal stroke
Timeframe: estimated 2.5 to 4 years
Time to bone fracture
Timeframe: estimated 2.5 to 4 years
Time to parathyroidectomy
Timeframe: estimated 2.5 to 4 years
Study Documents
Study Synopsis
Available Language(s): English
Locations
No locations found.