NCT00042653

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

A Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of an Oral Calcimimetic Agent (AMG 073) in Secondary Hyperparathyroidism of Chronic Kidney Disease (Hemodialysis and Peritoneal Dialysis)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 380 (estimated)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Secondary Hyperparathyroidism
• End Stage Renal Disease

Interventions

Type	Name	Description
DRUG	Placebo	30 mg of placebo taken once daily orally 60 mg of placebo taken once daily orally 90 mg of placebo taken once daily orally 120 mg of placebo taken once daily orally 180 mg of placebo taken once daily orally
DRUG	AMG 073	30 mg of AMG 073 taken once daily orally 60 mg of AMG 073 taken once daily orally 90 mg of AMG 073 taken once daily orally 120 mg of AMG 073 taken once daily orally 180 mg of AMG 073 taken once daily orally

Timeline

• Start date: 2002-05-01
• Primary completion: 2003-07-01
• Completion: 2003-07-01
• First posted: 2002-08-06
• Last updated: 2013-05-08