Safety and Efficacy Study of AMG 073 in Hemodialysis Subjects - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 6, 2007

Last Updated Date

January 22, 2009

Start Date ^†

February 2002

Current Primary Outcome Measures ^†

To evaluate the efficacy of AMG 073 compared with placebo by determining the proportion of subjects with a mean intact parathyroid hormone (iPTH) value <= 250 pg/mL (26.5 pmol/L) during the efficacy assessment phase. [ Time Frame: Efficacy Assessment Phase - last 14 weeks of study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00527267 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

To evaluate the efficacy of AMG 073 compared with placebo by determining: the proportion of subjects with a reduction from baseline in iPTH of >= during the efficacy assessment phase [ Time Frame: Efficacy Assessment Phase - last 14 weeks of study ] [ Designated as safety issue: No ]
To evaluate the efficacy of AMG 073 compared with placebo by determining: percentage change from baseline in calcium x phosphorus (Ca x P) during the efficacy assessment phase [ Time Frame: Efficacy Assessment Phase - last 14 weeks of study ] [ Designated as safety issue: No ]
To evaluate the efficacy of AMG 073 compared with placebo by determining: changes in self-reported cognitive function from baseline to the end of the efficacy assessment phase [ Time Frame: Efficacy Assessment Phase - last 14 weeks of study ] [ Designated as safety issue: No ]
To evaluate the safety of AMG 073 compared with placebo. [ Time Frame: Entire study - 26 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Safety and Efficacy Study of AMG 073 in Hemodialysis Subjects

Official Title ^†

A Phase 3 Study to Assess the Efficacy and Safety of an Oral Calcimimetic Agent (AMG 073) in Secondary Hyperparathyroidism of End Stage Renal Disease Treated With Hemodialysis

Brief 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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Condition ^†

Hyperparathyroidism

Intervention ^†

Drug: Placebo
Drug: AMG 073

Study Arms / Comparison Groups

Experimental: AMG 073
Placebo Comparator: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Estimated Enrollment ^†

320

Completion Date

April 2003

Primary Completion Date

April 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00527267

Responsible Party

Global Development Leader, Amgen Inc.

Secondary IDs ^††

Study Sponsor ^†

Amgen

Collaborators ^††

Investigators ^†

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.