Safety and Efficacy Study of AMG 073 in Hemodialysis Subjects

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

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2003-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hyperparathyroidism

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 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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men and Women greater than or equal to 18 years of age
* Using effective contraceptive measures
* Mean iPTH during screening of greater than or equal to 300 pg/mL
* Mean calcium during screening of greater than or equal to 8.4 mg/dL
* Stable on hemodialysis

Exclusion Criteria

* Unstable medical conditions
* Parathyroidectomy within 3 months
* Change in Vitamin D therapy
* Receiving antidepressants
* Experienced an MI within 3 months
* Inability to swallow tablets
* Previously received AMG 073

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No