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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2003-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Secondary Hyperparathyroidism End Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AMG 073

Group Type EXPERIMENTAL

AMG 073

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients must be receiving hemodialysis; have elevated parathyroid hormone levels; not be pregnant or nursing; and not have had a heart attack in the last 3 months.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No