A Study of an Investigational Medication for Severe Primary Hyperparathyroidism or Parathyroid Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

May 17, 2002

Last Updated Date

November 12, 2009

Start Date ^ICMJE

April 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Changes in serum calcium and PTH

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00037518 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety and tolerability of cinacalcet

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Study of an Investigational Medication for Severe Primary Hyperparathyroidism or Parathyroid Cancer

Official Title ^ICMJE

An Assessment of the Calcimimetic Agent AMG 073 for the Treatment of Subjects With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism.

Brief Summary

This study will assess an investigational medication for patients with severe primary hyperparathyroidism or parathyroid cancer.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hyperparathyroidism
Parathyroid Neoplasms

Intervention ^ICMJE

Drug: AMG 073

Study Arms / Comparison Groups

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 ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Patients must have parathyroid carcinoma or severe primary hyperparathyroidism; * Abnormally elevated calcium levels above 12.5 mg/dL; * Not be pregnant or nursing; * Not have had any type of cancer other than parathyroid carcinoma within the last 5 years.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00037518

Responsible Party

Global Development Leader, Amgen Inc.

Study ID Numbers ^ICMJE

20000204

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP