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Safety and Efficacy Study of AMG 073 in Hemodialysis Subjects

NCT00527267 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2009-01-26

No results posted yet for this study

Summary

Subjects on Hemodialysis will be randomized to AMG 073 or placebo. The screening period is a maximum of 30 days followed by a 26-week treatment period. Lab assessments will be completed throughout the study along with PRO assessments.

Conditions

  • Hyperparathyroidism

Interventions

DRUG

Placebo

30 mg placebo once daily orally 60 mg placebo once daily orally 90 mg placebo once daily orally 120 mg placebo once daily orally 180 mg placebo once daily orally

DRUG

AMG 073

30 mg AMG 073 once daily 60 mg AMG 073 once daily 90 mg AMG 073 once daily 120 mg AMG 073 once daily 180 mg AMG 073 once daily

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-02-28
Primary Completion
2003-04-30
Completion
2003-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00527267 on ClinicalTrials.gov