Study Complete
Sponsor ID
20050182

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

Sponsor ID
20050182
Clinicaltrials.gov ID
NCT00345839
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 3
Product
cinacalcet hcl
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
3883
Additional Study Details

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.