A Study of an Investigational Medication for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

July 29, 2002

Last Updated Date

October 15, 2009

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00042432 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A Study of an Investigational Medication for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients

Official Title ^ICMJE

Brief Summary

This study will assess an investigational medication for patients with chronic renal insufficiency (pre-dialysis) who have secondary hyperparathyroidism.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Secondary Hyperparathyroidism
Chronic Renal Insufficiency

Intervention ^ICMJE

Drug: AMG 073

Study Arms / Comparison Groups

Publications *

Charytan C, Coburn JW, Chonchol M, Herman J, Lien YH, Liu W, Klassen PS, McCary LC, Pichette V. Cinacalcet hydrochloride is an effective treatment for secondary hyperparathyroidism in patients with CKD not receiving dialysis. Am J Kidney Dis. 2005 Jul;46(1):58-67.

* 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 chronic renal insufficiency (pre-dialysis); * Have below normal creatinine clearance; * Have elevated parathyroid hormone levels; * Not be pregnant or nursing; and * Not have had a heart attack in the last 3 months.

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

NCT00042432

Responsible Party

Global Development Leader, Amgen Inc.

Study ID Numbers ^ICMJE

20010239

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

October 2009

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