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

Phase 3 Completed 380 enrolled Amgen

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start: 2002-05
Primary completion: 2003-07
Completion: 2003-07

Publications

Results Lindberg JS, Culleton B, Wong G, Borah MF, Clark RV, Shapiro WB, Roger SD, Husserl FE, Klassen PS, Guo MD, Albizem MB, Coburn JW. Cinacalcet HCl, an oral calcimimetic agent for the treatment of secondary hyperparathyroidism in hemodialysis and peritoneal dialysis: a randomized, double-blind, multicenter study. J Am Soc Nephrol. 2005 Mar;16(3):800-7. doi: 10.1681/ASN.2004060512. Epub 2005 Feb 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cinacalcet	Other / unclassified	30 mg	Oral
Subject	Cinacalcet	Other / unclassified	60 mg	Oral
Subject	Cinacalcet	Other / unclassified	90 mg	Oral
Subject	Cinacalcet	Other / unclassified	120 mg	Oral
Subject	Cinacalcet	Other / unclassified	180 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications