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

PHASE3CompletedINTERVENTIONAL
Enrollment

3,883

Participants

Timeline

Start Date

August 22, 2006

Primary Completion Date

April 10, 2012

Study Completion Date

April 10, 2012

Conditions
Secondary HyperparathyroidismChronic Kidney Disease
Interventions
DRUG

Cinacalcet

Possible doses: 30, 60, 90, 120, and 180 mg using tablet strengths of 30, 60, or 90 mg. Sequential titration starting at 30 mg daily (QD), once every 4 weeks for the first 20 weeks and once every 8 weeks after Week 20. Titration increases or decreases based on PTH values, serum calcium, and safety. Daily dosing unless temporary hold criteria or withdrawal criteria is met, or until study completion; estimated 2.5 to 4 years of intervention.

DRUG

Placebo

Possible doses: 30, 60, 90, 120, and 180 mg using tablet strengths of 30, 60, or 90 mg. Sequential titration starting at 30 mg QD, once every 4 weeks for the first 20 weeks and once every 8 weeks after Week 20. Titration increases or decreases based on PTH values, serum calcium, and safety. Daily dosing unless temporary hold criteria or withdrawal criteria is met, or until study completion; estimated 2.5 to 4 years of intervention.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY

NCT00345839 - E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events | Biotech Hunter | Biotech Hunter