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Clinical Trial Details

Trial ID: L0983
Source ID: NCT00345839
Associated Drug: Cinacalcet
Title: E.V.O.L.V.E. Trialâ„¢: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events
Acronym: EVOLVE
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00345839/results
Conditions: Secondary Hyperparathyroidism|Chronic Kidney Disease
Interventions: DRUG: Cinacalcet|DRUG: Placebo
Outcome Measures: Primary: Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event), Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event). Stratified by history of diabetes and country., From date of randomization until date of first confirmed primary composite endpoint event, assessed up to 5.4 years | Secondary: Time to All-cause Mortality, Time to All-cause Mortality. Stratified by history of diabetes and country., From date of randomization until date of confirmed all-cause mortality endpoint event, assessed up to 5.4 years|Time to Myocardial Infarction, Time to Myocardial Infarction. Stratified by history of diabetes and country., From date of randomization until date of first confirmed myocardial infarction endpoint event, assessed up to 5.4 years|Time to Hospitalization for Unstable Angina, Time to Hospitalization for Unstable Angina. Stratified by history of diabetes and country., From date of randomization until date of first confirmed hospitalization for unstable angina endpoint event, assessed up to 5.4 years|Time to Heart Failure, Time to Heart Failure. Stratified by history of diabetes and country., From date of randomization until date of first confirmed heart failure endpoint event, assessed up to 5.4 years|Time to Peripheral Vascular Event, Time to Peripheral Vascular Event. Stratified by history of diabetes and country., From date of randomization until date of first confirmed peripheral vascular endpoint event, assessed up to 5.4 years|Time to Cardiovascular Mortality, Time to Cardiovascular Mortality. Stratified by history of diabetes and country., From date of randomization until date of first confirmed cardiovascular mortality endpoint event, assessed up to 5.4 years|Time to Stroke, Time to Stroke. Stratified by history of diabetes and country., From date of randomization until date of first confirmed stroke endpoint event, assessed up to 5.4 years|Time to Bone Fracture, Time to Bone Fracture. Stratified by history of diabetes and country., From date of randomization until date of first confirmed bone fracture endpoint event, assessed up to 5.4 years|Time to Parathyroidectomy, Time to Parathyroidectomy. Stratified by history of diabetes and country., From date of randomization until date of first confirmed parathyroidectomy endpoint event, assessed up to 5.4 years
Sponsor/Collaborators: Sponsor: Amgen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 3883
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2006-08-22
Completion Date: 2012-04-10
Results First Posted: 2014-01-22
Last Update Posted: 2022-11-07
Locations:
URL: https://clinicaltrials.gov/show/NCT00345839