A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Patients on Dialysis

Sponsor ID

20000188

Clinicaltrials.gov ID

NCT00042653

EUCTIS ID

N/A

EudraCT ID

N/A

Study Details

This 6 month study will assess an investigational medication for patients on dialysis with secondary hyperparathyroidism. The study will look at the effects on parathyroid hormone, calcium and phosphorus levels.

Additional Study Details

Phase

Phase 3

Product

cinacalcet hcl

Type

Interventional

Masking

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Enrollment

380

Additional Study Details

Protocol Summary

Primary Outcome Measures

To evaluate the efficacy of AMG 073 compared with placebo by determining the proportion of subjects with a mean intact parathyroid hormone (iPTH) value <= 250 pg/mL (26.5 pmol/L) during the efficacy assessment phase.

Timeframe: Efficacy Assessment phase - final 10 weeks of study

Secondary Outcome Measures

To evaluate the efficacy of AMG 073 compared with placebo by determining: the proportion of subjects with a reduction from baseline in mean iPTH of >= 30% during the efficacy assessment phase

Timeframe: Efficacy Assessment phase - final 10 weeks of study

To evaluate the efficacy of AMG 073 compared with placebo by determining: percentage change from baseline in iPTH during the efficacy assessment phase

Timeframe: Efficacy Assessment phase - final 10 weeks of study

To evaluate the safety of AMG 073 compared with placebo

Timeframe: Entire study - 26 weeks

Locations

No locations found.